CALCIUM: 15,685 Adverse Event Reports & Safety Profile

DESCRIPTION Cardioplegic Solution is a sterile, nonpyrogenic, essentially isotonic, formulation of electrolytes in water for injection. It is a "core solution" intended for use only after addition of sodium bicarbonate to adjust pH prior to administration. After buffering with sodium bicarbonate it is suitable for cardiac instillation (usually with hypothermia) to induce arrest during open heart surgery. Other agents may be added to the solution prior to instillation (See INSTRUCTIONS FOR USE ).

Each

100 mL of solution contains calcium chloride, dihydrate 17.6 mg, magnesium chloride, hexahydrate 325.3 mg, potassium chloride 119.3 mg and sodium chloride 643 mg in water for injection. May contain HCl or NaOH for pH adjustment. Electrolyte content per liter (not including ions for pH adjustment): Calcium (Ca ++ ) 2.4 mEq; magnesium (Mg ++ ) 32 mEq; potassium (K + ) 16 mEq; sodium (Na + ) 110 mEq; chloride (Cl‾) 160 mEq. Osmolar concentration, 304 mOsmol/liter (calc.); pH 3.8 (3.5 to 3.9) prior to sodium bicarbonate addition. It is required that 10 mL (840 mg) of 8.4% Sodium Bicarbonate Injection, USP (10 mEq each of sodium and bicarbonate) be added aseptically and thoroughly mixed with each 1000 mL of cardioplegic solution to adjust pH.

Use

10 mL of 8.4% Sodium Bicarbonate Injection, USP, to achieve the approximate pH of 7.8 when measured at room temperature. Use of any other Sodium Bicarbonate Injection may not achieve this pH due to the varying pH's of Sodium Bicarbonate Injections. Due to its inherent instability with other components, sodium bicarbonate must be added just prior to administration. After this addition, the solution must be stored under refrigeration and be used within 24 hours. The buffered admixture contains the following electrolytes (per liter): Ca ++ 2.4 mEq, Mg ++ 32 mEq, K + 16 mEq, Na + 120 mEq, Cl‾ 160 mEq and bicarbonate (HCO 3 ‾) 10 mEq; osmolar concentration, 324 mOsmol/liter (calc.); pH 7.8 (approx.). If other agents are added, these values may be altered. The solution contains no bacteriostat, or antimicrobial agent and is intended only for use (after adjusting pH with sodium bicarbonate) in a single operative procedure. When smaller amounts are required, the unused portion should be discarded.

Cardioplegic

Solution with added sodium bicarbonate used as a coronary artery infusate induces cardiac arrest, combats ischemic ionic disturbances, buffers ischemic acidosis and protects energy sources for functional recovery after ischemia.

Calcium

Chloride, USP is chemically designated calcium chloride, dihydrate (CaCl 2

• 2 H 2 O), white fragments or granules freely soluble in water.

Magnesium

Chloride, USP is chemically designated magnesium chloride, hexahydrate (MgCl 2

• 6 H 2 O), deliquescent flakes or crystals very soluble in water.

Potassium

Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water.

Sodium

Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for Injection, USP is chemically designated H 2 O. The flexible plastic container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers ( free flex ® bag). Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.

Uses for temporary relief of minor discomfort of the throat

Uses for temporary relief of minor discomfort of the throat

Uses for temporary relief of minor discomfort of the throat

Uses for temporary relief of minor discomfort of the throat.

Uses

For temporary relief of minor discomfort of the throat

Uses For temporary relief of minor discomfort of the throat

Uses For temporary relief of minor discomfort of the throat

Uses for temporary relief of minor discomfort of the throat

Uses for temporary relief of minor discomfort of the throat

Uses for temporary relief of minor discomfort of the throat

Uses For temporary relief of minor discomfort of the throat

Uses For temporary relief of minor discomfort of the throat

Uses for temporary relief of minor discomfort of the throat

Uses for temporary relief of minor discomfort of the throat

Uses For temporary relief of minor discomfort of the throat

Uses For temporary relief of minor discomfort of the throat

Uses for temporary relief of minor discomfort of the throat

Uses for temporary relief of minor discomfort of the throat

Uses For temporary relief of minor discomfort of the throat

Uses for temporary relief of minor discomfort of the throat

Uses for temporary relief of minor discomfort of the throat

Uses for temporary relief of minor discomfort of the throat

Uses for temporary relief of minor discomfort of the throat

Uses for temporary relief of minor discomfort of the throat

Uses for temporary relief of minor discomfort of the throat

Uses Relieves: heartburn, sour stomach, acid indigestion

Uses Relieves: heartburn, sour stomach, acid indigestion

Uses Relieves:

• heartburn
• sour stomach
• acid indigestion

Uses Relieves: heartburn sour stomach acid indigestion

Uses for temporary relief of minor discomfort of the throat

Uses for temporary relief of minor discomfort of the throat

Uses for temporary relief of minor discomfort of the throat

Uses for temporary relief of minor discomfort of the throat

Uses for temporary relief of minor discomfort of the throat

Uses for temporary relief of minor discomfort of the throat

Uses for temporary relief of minor discomfort of the throat

AND ADMINISTRATION Contains 100 mg of calcium gluconate per mL which contains 9.3 mg (0.465 mEq) of elemental calcium ( 2.1 )

See Full Prescribing

Information (FPI) for dilution instructions, administration rates, and appropriate monitoring ( 2.1 ) Individualize the dose within the recommended range in adults and pediatric patients depending on the severity of symptoms of hypocalcemia, the serum calcium level, and the acuity of onset of hypocalcemia.

See Table

1 in the FPI for dosing recommendations in mg of calcium gluconate for neonates, pediatric and adult patients. ( 2.2 ) Measure serum calcium during intermittent infusions every 4 to 6 hours and during continuous infusion every 1 to 4 hours. ( 2.3 )

Calcium Gluconate

Injection is not physically compatible with fluids containing phosphate or bicarbonate. Precipitation may result if mixed. See FPI for all drug incompatibilities. ( 2.5 ) Supplied in a pharmacy bulk package (PBP). For PBP, dispense single doses to many patients in a pharmacy admixture program; use within 4 hours of puncture ( 2.6 )

2.1 Important Administration Instructions Calcium Gluconate Injection contains 100 mg of calcium gluconate per mL which contains 9.3 mg (i.e., 0.465 mEq) of elemental calcium.

Dilute Calcium Gluconate

Injection prior to use in 5% dextrose or normal saline and assess for potential drug or IV fluid incompatibilities [see Dosage and Administration ( 2.5 )].

Inspect Calcium Gluconate

Injection visually prior to administration. The solution should appear clear and colorless to slightly yellow. Do not administer if there is particulate matter or discoloration. Use the diluted solution immediately after preparation.

Administer Calcium Gluconate

Injection intravenously via a secure intravenous line to avoid calcinosis cutis and tissue necrosis [see Warnings and Precautions ( 5.3 )].

Administer Calcium Gluconate

Injection by bolus administration or continuous infusion: For bolus intravenous administration: Dilute the dose [see Dosage and Administration ( 2.2 )] of Calcium Gluconate Injection in 5% dextrose or normal saline to a concentration of 10-50 mg/mL prior to administration. Administer the dose slowly and DO NOT exceed an infusion rate of 200 mg/minute in adults or 100 mg/minute in pediatric patients, including neonates. Monitor patients, vitals and electrocardiograph (ECG) during administration [see Warnings and Precautions ( 5.4 )]. For continuous intravenous infusion: Dilute Calcium Gluconate Injection in 5% dextrose or normal saline to a concentration of 5.8-10 mg/mL prior to administration. Administer at the rate recommended in Table 1 [see Dosage and Administration ( 2.2 )] and monitor patients, vitals, calcium and ECG during the infusion [see Warnings and Precautions ( 5.4 )] .

Calcium Gluconate

Injection is supplied in pharmacy bulk packages [see Dosage and Administration ( 2.6 )].

2.2 Recommended Dosage Individualize the dose of Calcium Gluconate Injection within the recommended range depending on the severity of symptoms of hypocalcemia, the serum calcium level, and the acuity of onset of hypocalcemia.

Table

1 provides dosing recommendations for Calcium Gluconate Injection in mg of calcium gluconate for neonates, pediatric and adult patients.

Table

1 .

Dosing

Recommendations in mg of Calcium Gluconate for Neonate, Pediatric, and Adult Patients Patient Population Initial Dose Subsequent Doses (if needed)

Bolus Continuous Infusion

Neonate (≤ 1 month) 100 - 200 mg/kg 100 - 200 mg/kg every 6 hours Initiate at 17 - 33 mg/kg/hour Pediatric (> 1 month to < 17 years) 29 - 60 mg/kg 29 - 60 mg/kg every 6 hours Initiate at 8 - 13 mg/kg/hour Adult 1000 - 2000 mg 1000 - 2000 mg every 6 hours Initiate at 5.4 - 21.5 mg/kg/hour For bolus administration, DO NOT exceed an infusion rate of: 200 mg/minute in adult patients 100 mg/minute in pediatric patients For continuous infusions, adjust rate as needed based on serum calcium levels

2.3 Serum Calcium Monitoring Measure serum calcium every 4 to 6 hours during intermittent infusions with Calcium Gluconate Injection and measure serum calcium every 1 to 4 hours during continuous infusion.

2.4 Dosage in Renal Impairment For patients with renal impairment, initiate Calcium Gluconate Injection at the lowest dose of the recommended dose ranges for all age groups and monitor serum calcium levels every 4 hours.

2.5 Drug Incompatibilities Do not mix Calcium Gluconate Injection with ceftriaxone. Concurrent use of intravenous ceftriaxone and Calcium Gluconate Injection can lead to the formation of ceftriaxone-calcium precipitates. Concomitant use of ceftriaxone and intravenous calcium-containing products is contraindicated in neonates (28 days of age or younger) <span class="opacity-50 text-xs">[see Contraindications ( 4 )]</span>. In patients older than 28 days of age, ceftriaxone and calcium-containing products may be administered sequentially, provided the infusion lines are thoroughly flushed between infusions with a compatible fluid. Ceftriaxone must not be administered simultaneously with intravenous calcium-containing solutions via a Y-site in any age group <span class="opacity-50 text-xs">[see Warnings and Precautions ( 5.2 ), Drug Interactions ( 7.3 )]</span>. Do not mix Calcium Gluconate Injection with fluids containing bicarbonate or phosphate.

Calcium Gluconate

Injection is not physically compatible with fluids containing phosphate or bicarbonate. Precipitation may result if mixed. Do not mix Calcium Gluconate Injection with minocycline injection. Calcium complexes minocycline rendering it inactive.

2.6 Preparation of Pharmacy Bulk Package The pharmacy bulk package (PBP) of Calcium Gluconate Injection is intended for dispensing of single doses to multiple patients in a pharmacy admixture program. Penetrate the container closure only one time with a suitable sterile transfer device or dispensing set that allows measured dispensing of the contents. Use the PBP only in a suitable ISO Class 5 work area such as a laminar flow hood (or an equivalent clean air compounding area). Complete dispensing from the pharmacy bulk vial within 4 hours after the container closure is penetrated. Each dose dispensed from the Pharmacy Bulk Package must be used immediately. CAUTION: DO NOT ADD SUPPLEMENTARY MEDICATION. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration or admixture and final infusate should be inspected for cloudiness or precipitation immediately after mixing, prior to administration, and periodically during administration, whenever solution and container permit. Use of a final filter is recommended during administration of all parenteral solutions where possible. This solution is intended for use in the preparation of sterile, intravenous admixtures. Protect from light until use. When compounding admixtures, use aseptic technique. Mix thoroughly. Do not store any unused portion.

Identify Two

Ports (See Figure A). To aseptically remove the set port closure: hold container below the set port and grasp the foil tab between the thumb and forefinger then pull the tab in two steps as shown in Figure B Steps 1 and 2. The foil tab maintains port sterility; therefore, it should be removed in a suitable environment such as a laminar flow hood. Attach suitable transfer device or compounding set (See Figure C) . Refer to complete directions of accompanying device. Hang container using hole on the lower flap. Once container closure has been penetrated, withdrawal of contents should be completed within 4 hours. Figure A Figure B Figure C

2.1 Important Administration Instructions Calcium Gluconate Injection contains 100 mg of calcium gluconate per mL which contains 9.3 mg (i.e., 0.465 mEq) of elemental calcium.

Dilute Calcium Gluconate

Injection prior to use in 5% dextrose or normal saline and assess for potential drug or IV fluid incompatibilities [see Dosage and Administration ( 2.5 )].

Inspect Calcium Gluconate

Injection visually prior to administration. The solution should appear clear and colorless to slightly yellow. Do not administer if there is particulate matter or discoloration. Use the diluted solution immediately after preparation.

Administer Calcium Gluconate

Injection intravenously via a secure intravenous line to avoid calcinosis cutis and tissue necrosis [see Warnings and Precautions ( 5.3 )].

Administer Calcium Gluconate

Injection by bolus administration or continuous infusion: For bolus intravenous administration: Dilute the dose [see Dosage and Administration ( 2.2 )] of Calcium Gluconate Injection in 5% dextrose or normal saline to a concentration of 10-50 mg/mL prior to administration. Administer the dose slowly and DO NOT exceed an infusion rate of 200 mg/minute in adults or 100 mg/minute in pediatric patients, including neonates. Monitor patients, vitals and electrocardiograph (ECG) during administration [see Warnings and Precautions ( 5.4 )]. For continuous intravenous infusion: Dilute Calcium Gluconate Injection in 5% dextrose or normal saline to a concentration of 5.8-10 mg/mL prior to administration. Administer at the rate recommended in Table 1 [see Dosage and Administration ( 2.2 )] and monitor patients, vitals, calcium and ECG during the infusion [see Warnings and Precautions ( 5.4 )] .

Calcium Gluconate

Injection is supplied in pharmacy bulk packages [see Dosage and Administration ( 2.6 )].

2.2 Recommended Dosage Individualize the dose of Calcium Gluconate Injection within the recommended range depending on the severity of symptoms of hypocalcemia, the serum calcium level, and the acuity of onset of hypocalcemia.

Table

1 provides dosing recommendations for Calcium Gluconate Injection in mg of calcium gluconate for neonates, pediatric and adult patients.

Table

1 .

Dosing

Recommendations in mg of Calcium Gluconate for Neonate, Pediatric, and Adult Patients Patient Population Initial Dose Subsequent Doses (if needed)

Bolus Continuous Infusion

Neonate (≤ 1 month) 100 - 200 mg/kg 100 - 200 mg/kg every 6 hours Initiate at 17 - 33 mg/kg/hour Pediatric (> 1 month to < 17 years) 29 - 60 mg/kg 29 - 60 mg/kg every 6 hours Initiate at 8 - 13 mg/kg/hour Adult 1000 - 2000 mg 1000 - 2000 mg every 6 hours Initiate at 5.4 - 21.5 mg/kg/hour For bolus administration, DO NOT exceed an infusion rate of: 200 mg/minute in adult patients 100 mg/minute in pediatric patients For continuous infusions, adjust rate as needed based on serum calcium levels

2.3 Serum Calcium Monitoring Measure serum calcium every 4 to 6 hours during intermittent infusions with Calcium Gluconate Injection and measure serum calcium every 1 to 4 hours during continuous infusion.

Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection is contraindicated in:

• Neonates (28 days of age or younger) who are receiving concomitant treatment with ceftriaxone, even if separate infusion lines are used, due to the risk of fatal ceftriaxone-calcium salt precipitation in the neonate’s bloodstream [see Warnings and Precautions (5.1) and Specific Populations (8.4) ] .
• Patients with known hypersensitivity to any of the components of Potassium Chloride in Lactated Ringer’s solution and Dextrose (5%) Injection [see Warnings and Precautions (5.3) ] .
• Patients with clinically significant hyperkalemia [see Warnings and Precautions (5.4) ] .
• Patients with clinically significant hyperglycemia [see Warnings and Precautions (5.7) ] .
• Concomitant treatment with ceftriaxone in neonates (28 days of age or younger). ( 4 )
• Patients with known hypersensitivity to any of the components of Potassium Chloride in Lactated Ringer’s solution and Dextrose (5%) Injection ( 4 )
• Patients with clinically significant hyperkalemia ( 4 ).
• Patients with clinically significant hyperglycemia ( 4 ).

REACTIONS The most common adverse reaction (incidence > 5%) was rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Vantive US Healthcare LLC at 1-855-857-0003 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Trials Experience EXTRANEAL was originally studied in controlled clinical trials of 493 patients with kidney failure in patients requiring long-term kidney replacement therapy who received a single daily exchange of EXTRANEAL for the long dwell (8-to 16- hours). There were 215 patients exposed for at least 6 months and 155 patients exposed for at least one year. The population was 18-83 years of age, 56% male and 44% female, 73% Caucasian, 18% Black, 4% Asian, 3% Hispanic, and it included patients with the following comorbid conditions: 27% diabetes, 49% hypertension and 23% hypertensive nephropathy. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates. Rash was the most frequently occurring EXTRANEAL-related adverse reaction (5.5%, EXTRANEAL; 1.7% Control). Seven patients on EXTRANEAL discontinued treatment due to rash, and one patient on EXTRANEAL discontinued due to exfoliative dermatitis. The rash typically appeared within the first three weeks of treatment and resolved with treatment discontinuation or, in some patients, with continued treatment.

Table

1 shows the adverse events reported in these clinical studies regardless of causality, occurring in ≥ 5% of patients and more common on EXTRANEAL than control.

Table

1 - Adverse Experiences in ≥5% of Patients and More Common on EXTRANEAL EXTRANEAL Control N = 493 N = 347 Peritonitis 26% 25% Upper respiratory infection 15% 13% Hypertension 13% 8% Rash 10% 5% Headache 9% 7% Abdominal Pain 8% 6% Flu syndrome 7% 6% Nausea 7% 5% Cough increase 7% 4% Edema 6% 5% Accidental injury 6% 4% Chest pain 5% 4% Dyspepsia 5% 4% Hyperglycemia 5% 4% Clinical Laboratory Findings An increase in mean serum alkaline phosphatase has been observed in clinical studies of ESRD patients receiving EXTRANEAL. No associated increases in other liver chemistry tests were observed. Serum alkaline phosphatase levels did not show progressive increase over a 12-month study period. Levels returned to normal approximately two weeks after discontinuation of EXTRANEAL. Decreases in serum sodium and chloride have been observed in patients using EXTRANEAL. The mean change in serum sodium from baseline to the last study visit was -2.8 mmol/L for patients on EXTRANEAL and -0.3 mmol/L for patients on control solution. Four EXTRANEAL patients and two control patients developed serum sodium < 125 mmol/L. The mean change in serum chloride from baseline to last study visit was -2 mmol/L for EXTRANEAL patients and + 0.6 mmol/L for control patients. Similar changes in serum chemistries were observed in an additional clinical study in a subpopulation of high average/high transporter patients. The declines in serum sodium and chloride may be related to dilution resulting from the presence of icodextrin metabolites in plasma. An apparent decrease in serum amylase activity has been observed in patients administered EXTRANEAL. Investigations indicate that icodextrin and its metabolites interfere with enzymatic-based amylase assays, resulting in inaccurately low values. This should be taken into account when evaluating serum amylase levels for diagnosis or monitoring of pancreatitis in patients using EXTRANEAL.

6.2 Post-Marketing Experience The following adverse reactions have been identified during post-approval use of EXTRANEAL, or in conjunction with performing the peritoneal dialysis procedure. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to estimate their frequency reliably or to establish a causal relationship to drug exposure. INFECTIONS AND INFESTATIONS: Fungal peritonitis, Peritonitis bacterial, Catheter related infection BLOOD AND LYMPHATIC SYSTEM DISORDERS: Thrombocytopenia, Leukopenia, Leukocytosis IMMUNE SYSTEM DISORDERS: Vasculitis, Serum sickness, Hypersensitivity METABOLISM AND NUTRITION DISORDERS: Hypoglycemic shock, Dehydration NERVOUS SYSTEM DISORDERS: Hypoglycemic coma, Burning sensation EYE DISORDERS: Vision blurred RESPIRATORY, THORACIC, AND MEDIASTINAL DISORDERS: Bronchospasm, Stridor GASTROINTESTINAL DISORDERS: Encapsulating peritoneal sclerosis, Aseptic peritonitis, Ileus, Ascites, Inguinal hernia SKIN AND SUBCUTANEOUS DISORDERS: Toxic epidermal necrolysis, Angioedema, Urticaria generalized, Prurigo, Dermatitis (including bullous, allergic and contact), Erythema, Onychomadesis, Dry skin, Skin chapped, Blister MUSCULOSKELETAL, CONNECTIVE TISSUE DISORDERS: Musculoskeletal pain REPRODUCTIVE SYSTEM AND BREAST DISORDERS: Penile edema, Scrotal edema GENERAL DISORDERS AND ADMINISTRATIVE SITE CONDITIONS: Pyrexia, Chills, Malaise, Catheter site erythema, Catheter site inflammation, Infusion related reaction (including Infusion site pain, Instillation site pain) INVESTIGATIONS: Liver function test abnormal, Urine output decreased

Warnings Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. Stop use and ask a doctor if: sore throat does not improve in 7 days irritation, pain, or redness persists or worsens Keep out of reach of children.

Warnings

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. Stop use and ask a doctor if sore throat does not improve in 7 days irritation, pain, or redness persists or worsens Keep out of reach of children.

Warnings

Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. Stop use and ask a doctor if sore throat does not improve in 7 days irritation, pain, or redness persists or worsens Keep out of reach of children.

Warnings

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. Stop use and ask a doctor if sore throat does not improve in 7 days. irritation, pain, or redness persists or worsens. Keep out of reach of children.

Warnings

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea or vomiting, consult a doctor promptly. These may be serious. Stop use and ask a doctor if sore throat does not improve in 7 days Keep out of reach of children.

Warnings

Sore throat warning: If sore throat is severe, persists for more than 7 days, is accompanied or followed by fever, headache, rash, swelling, nausea or vomiting, consult a doctor promptly. These may be serious. Stop use and ask a doctor if sore throat does not improve in 7 days irritation, pain, or redness persists or worsens Keep out of reach of children.

Warnings

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea or vomiting, consult a doctor promptly. These may be serious. Stop use and ask a doctor if sore throat does not improve in 7 days. Keep out of reach of children.

Warnings

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. Stop use and ask a doctor if: sore throat does not improve in 7 days irritation, pain, or redness persists or worsens Keep out of reach of children.

Warnings

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. Stop use and ask a doctor if: sore throat does not improve in 7 days irritation, pain, or redness persists or worsens Keep out of reach of children.

Warnings

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea or vomiting, consult a doctor promptly. These may be serious. Stop use and ask a doctor if sore throat does not improve in 7 days irritation, pain, or redness persists or worsens Keep out of reach of children.

Warnings

Sore throat warning: If sore throat is severe, persists for more than 7 days, is accompanied or followed by fever, headache, rash, swelling, nausea or vomiting, consult a doctor promptly. These may be serious. Stop use and ask a doctor if Sore throat does not improve in 7 days Irritation, pain, or redness persists or worsens Keep out of reach of children.

Warnings

Sore throat warning: If sore throat is severe, persists for more than 7 days, is accompanied or followed by fever, headache, rash, swelling, nausea or vomiting, consult a doctor promptly. These may be serious. Stop use and ask a doctor if Sore throat does not improve in 7 days Irritation, pain, or redness persists or worsens Keep out of reach of children.

Warnings

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. Stop use and ask a doctor if sore throat does not improve in 7 days irritation, pain, or redness persists or worsens Keep out of reach of children.

Warnings

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. Stop use and ask a doctor if sore throat does not improve in 7 days irritation, pain, or redness persists or worsens Keep out of reach of children.

Warnings

Sore throat warning: if sore throat is severe, persists for more than 7 days, is accompanied or followed by fever, headache, rash, swelling, nausea or vomiting, consult a doctor promptly. These may be serious. Stop use and ask a doctor if sore throat does not improve in 7 days irritation, pain, or redness persists or worsens Keep out of reach of children.

Warnings

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea or vomiting, consult a doctor promptly. These may be serious. Stop use and ask a doctor if sore throat does not improve in 7 days Keep out of reach of children.

Warnings

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. Stop use and ask a doctor if sore throat does not improve in 7 days irritation, pain, or redness persists or worsens Keep out of reach of children.

Warnings

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. Stop use and ask a doctor if sore throat does not improve in 7 days irritation, pain, or redness persists or worsens Keep out of reach of children.

Warnings

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. These may be serious. Stop use and ask a doctor if sore throat does not improve in 7 days. Keep out of reach of children.

Warnings

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. Stop use and ask a doctor if sore throat does not improve in 7 days irritation, pain, or redness persists or worsens Keep out of reach of children.

Warnings

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea or vomiting, consult a doctor promptly. These may be serious. Stop use and ask a doctor if sore throat does not improve in 7 days irritation, pain, or redness persists or worsens Keep out of reach of children.

Warnings

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomitting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. Stop use and ask a doctor if sore throat does not improve in 7 days irritation, pain, or redness persists or worsens Keep out of reach of children.

Warnings

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. Stop use and ask a doctor if sore throat does not improve in 7 days irritation, pain, or redness persists or worsens Keep out of reach of children.

Warnings

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. Stop use and ask a doctor if sore throat does not improve in 7 days irritation, pain, or redness persists or worsens Keep out of reach of children.

Warnings

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. Stop use and ask a doctor if sore throat does not improve in 7 days irritation, pain, or redness persists or worsens Keep out of reach of children.

Warnings

Ask a doctor or pharmacist before use if the child is: presently taking a prescription drug. Antacids may interact with certain prescription drugs. Stop use and ask a doctor if symptoms last more than 2 weeks Keep this and all drugs out of the reach of children.

Warnings

Ask a doctor or pharmacist before use if the child is: presently taking a prescription drug. Antacids may interact with certain prescription drugs Stop use and ask a doctor if symptoms last more than 2 weeks Keep this and all drugs out of the reach of children.

Warnings

Ask a doctor or pharmacist before use if the child is: presently taking a prescription drug. Antacids may interact with certain prescription drugs. Do not take more than 6 pops (ages 3 to 5) to 12 pops (ages 6 to 12) in a 24-hour period, or use the maximum dosage for more than two weeks, except under the advice and supervision of a doctor Stop use and ask a doctor if symptoms last more than 2 weeks Keep out of reach of children.

Warnings

Ask a doctor or pharmacist before use if the child is: presently taking a prescription drug. Antacids may interact with certain prescription drugs. Do not take more than 6 pops (ages 3 to 5) to 12 pops (ages 6 to 12) in a 24-hour period, or use the maximum dosage for more than two weeks, except under the advice and supervision of a doctor Stop use and ask a doctor if symptoms last more than 2 weeks Keep out of reach of children.

Warnings

Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. Stop use and ask a doctor if sore throat does not improve in 7 days irritation, pain, or redness persists or worsens Keep out of reach of children.

Warnings

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. Stop use and ask a doctor if sore throat does not improve in 7 days irritation, pain, or redness persists or worsens Keep out of reach of children.

Warnings

Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. Stop use and ask a doctor if sore throat does not improve in 7 days irritation, pain, or redness persists or worsens Keep out of reach of children.

Warnings

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. Stop use and ask a doctor if sore throat does not improve in 7 days irritation, pain, or redness persists or worsens Keep out of reach of children.

Warnings

Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. Stop use and ask a doctor if sore throat does not improve in 7 days irritation, pain, or redness persists or worsens Keep out of reach of children.

Warnings

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. Stop use and ask a doctor if sore throat does not improve in 7 days irritation, pain, or redness persists or worsens Keep out of reach of children.

Warnings

Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. Stop use and ask a doctor if sore throat does not improve in 7 days irritation, pain, or redness persists or worsens Keep out of reach of children.

PRECAUTIONS General This solution should be used with care in patients with hypervolemia, renal insufficiency, urinary tract obstruction, or impending or frank cardiac decompensation. Extraordinary electrolytes losses such as may occur during protracted nasogastric suction, vomiting, diarrhea or gastrointestinal fistula drainage may necessitate additional electrolyte supplementation. Additional essential electrolytes, minerals and vitamins should be supplied as needed. Sodium-containing solutions should be administered with caution to patients receiving corticosteroids or corticotropin, or to other salt-retaining patients. Care should be exercised in administering solutions containing sodium or potassium to patients with renal or cardiovascular insufficiency, with or without congestive heart failure, particularly if they are postoperative or elderly. Potassium therapy should be guided primarily by serial electrocardiograms, especially in patients receiving digitalis. Serum potassium levels are not necessarily indicative of tissue potassium levels. Solutions containing calcium should be used with caution in the presence of cardiac disease, particularly when accompanied by renal disease. Parenteral calcium should be administered with extreme caution to patients receiving digitalis preparations. Solutions containing lactate should be used with caution. Excess administration may result in metabolic alkalosis. The conversion of lactate to bicarbonate is markedly delayed in the presence of tissue anoxia and reduced capacity of the liver to metabolize lactate. This may occur under conditions such as metabolic acidosis associated with circulatory insufficiency, extracorporeal circulation, hypothermia, glycogen storage disease, liver dysfunction, respiratory alkalosis, shock or cardiac decompensation. To minimize the risk of possible incompatibilities arising from mixing this solution with other additives that may be prescribed, the final infusate should be inspected for cloudiness or precipitation immediately after mixing, prior to administration, and periodically during administration. Do not use plastic container in series connection. If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result. If administration is not controlled by a pumping device, refrain from applying excessive pressure (>300mmHg) causing distortion to the container such as wringing or twisting. Such handling could result in breakage of the container. This solution is intended for intravenous administration using sterile equipment. It is recommended that intravenous administration apparatus be replaced at least once every 24 hours. Use only if solution is clear and container and seals are intact.

Laboratory Tests

Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation. Significant deviations from normal concentrations may require tailoring of the electrolyte pattern, in this or an alternative solution.

Drug Interactions Ceftriaxone

Precipitation of ceftriaxone-calcium can occur when ceftriaxone is mixed with calcium-containing solutions, such as Lactated Ringer’s Injection USP, in the same intravenous administration line. Do not administer ceftriaxone simultaneously with Lactated Ringer’s Injection USP via a Y-site. However, in patients other than neonates, ceftriaxone and Lactated Ringer’s Injection USP may be administered sequentially if the infusion lines are thoroughly flushed between infusions with a compatible fluid [see Warnings, Dosage and Administration ]. Deaths have occurred in neonates (28 days of age or younger) who received concomitant intravenous calcium-containing solutions with ceftriaxone resulting from calcium-ceftriaxone precipitates in the lungs and kidneys, even when separate infusion lines were used [see Contraindications, Warnings, Pediatric Use, Dosage and Administration ]. Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Carcinogenesis, Mutagenesis, Impairment of Fertility Studies with Lactated Ringer's Injection USP have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility. Pregnancy: Teratogenic Effects Animal reproduction studies have not been conducted with Lactated Ringer's Injection USP. It is also not known whether Lactated Ringer's Injection USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

Lactated

Ringer's Injection USP should be given to a pregnant woman only if clearly needed. Labor and Delivery As reported in the literature, Lactated Ringer's Injection USP has been administered during labor and delivery. Caution should be exercised, and the fluid balance, glucose and electrolyte concentrations, and acid-base balance, of both mother and fetus should be evaluated periodically or whenever warranted by the condition of the patient or fetus.

Nursing

Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Lactated Ringer's Injection USP is administered to a nursing woman.

Pediatric Use

Deaths have occurred in neonates (28 days of age or younger) who received concomitant intravenous calcium-containing solutions with ceftriaxone resulting from calcium-ceftriaxone precipitates in the lungs and kidneys, even when separate infusion lines were used.

Lactated

Ringer’s Injection USP is contraindicated in neonates receiving ceftriaxone [see Contraindications, Warnings, Drug Interactions ]. Safety and effectiveness of Lactated Ringer's Injection USP in pediatric patients have not been established by adequate and well controlled trials, however, the use of electrolyte solutions in the pediatric population is referenced in the medical literature. The warnings, precautions, and adverse reactions identified in the label copy should be observed in the pediatric population.

Geriatric Use

Clinical studies of Lactated Ringer's Injection USP did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

INTERACTIONS

• Drugs that Affect Electrolyte and/or Fluid Balance : Avoid concomitant use. If concomitant use cannot be avoided, closely monitor electrolyte concentrations and fluid balance. ( 7.1 )
• Lithium : Avoid concomitant use. If concomitant use is unavoidable, monitor serum lithium concentrations more frequently. ( 7.2 )
• Digoxin : Consider reducing the volume or rate of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection due to the increased risk of digoxin toxicity with calcium-containing solutions. ( 7.3 )
• Drugs with pH-Dependent Renal Elimination : Renal clearance of acidic drugs may be increased. In contrast, renal clearance of alkaline drugs may be decreased. ( 7.4 )

7.1 Drugs that Affect Electrolyte and/or Fluid Balance Hyperkalemia Administration of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection to patients concomitantly treated or recently treated with drugs that are associated with hyperkalemia increases the risk of severe and potentially fatal hyperkalemia, especially in the presence of other hyperkalemia risk factors. Avoid use of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection in patients receiving drugs that are associated with hyperkalemia (e.g., potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, or calcineurin inhibitors). If concomitant use cannot be avoided, closely monitor serum potassium concentrations during concomitant use <span class="opacity-50 text-xs">[see Warnings and Precautions (5.4) ]</span>.

Hyponatremia

Administration of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection to patients treated concomitantly with drugs associated with hyponatremia may increase the risk of developing hyponatremia. These drugs include diuretics and those that cause SIADH (e.g., arginine vasopressin analogs, certain antiepileptic, psychotropic, or cytotoxic drugs). Avoid use of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection in patients receiving such drugs. If use cannot be avoided, closely monitor serum sodium concentrations during concomitant use [see Warnings and Precautions (5.5) ].

Hypercalcemia

Avoid the use of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection in patients treated with thiazide diuretics or vitamin D because these drugs can increase the risk of hypercalcemia. If use cannot be avoided, closely monitor serum calcium concentrations during concomitant use [see Warnings and Precautions (5.8) ]. Hypernatremia and Fluid Retention Administration of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection to patients treated concomitantly with drugs associated with sodium and fluid retention (e.g., corticosteroids or corticotropin) may increase the risk of hypernatremia and volume overload. Avoid use of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection in patients receiving such drugs. If use cannot be avoided, closely monitor serum electrolytes, fluid balance, and acid-base balance during concomitant use.

7.2 Lithium Renal sodium and lithium clearance may be increased during concomitant use of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection and lithium and may result in decreased lithium concentrations. Avoid use of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection in patients receiving lithium. If use cannot be avoided, increase the frequency of monitoring of serum lithium concentrations during concomitant use.

7.3 Digoxin Administration of calcium via use of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection may increase digoxin’s effects and lead to digoxin toxicity including serious or fatal cardiac arrhythmias. In digoxin-treated patients, consider reducing the volume and/or rate of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection administration.

7.4 Drugs with pH-Dependent Renal Elimination Due to the alkalinizing action of lactate (formation of bicarbonate), Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection may interfere with the elimination of drugs with pH-dependent renal elimination. Renal clearance of alkaline drugs may be decreased. In contrast, renal clearance of acidic drugs may be increased.

7.5 Interference of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection with Interpretation of Serum Lactate Levels in Patients with Severe Metabolic Acidosis Because administration of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection may interfere with the interpretation of serum lactate levels in patients with severe metabolic acidosis, including lactic acidosis, assessment of the patient’s clinical status should not solely rely on the measurement of serum lactate.

Active Ingredient (in each pop)

Pectin

11.5 mg

Active Ingredient (in each drop)

Pectin

11.5 mg

Active Ingredient (in each drop)

Pectin

11.5 mg

Active ingredient (in each pop)

Pectin

11.5 mg

Active ingredient (in each pop)

Pectin

11.5 mg

Active ingredient (in each pop)

Pectin

11.5 mg

Active ingredient (in each pop)

Pectin

11.5 mg

Active Ingredient (in each pop)

Pectin

11.5 mg

Active Ingredient (in each pop)

Pectin

11.5 mg

Active Ingredient (in each pop)

Pectin

11.5 mg

Active ingredient (in each pop)

Pectin

11.5 mg

Active ingredient (in each pop)

Pectin

11.5 mg

Active Ingredient (in each pop)

Pectin

11.5 mg

Active Ingredient (in each pop)

Pectin

11.5 mg

Active ingredient (in each pop)

Pectin

11.5 mg

Active ingredient (in each pop)

Pectin

11.5 mg

Active Ingredient (in each pop)

Pectin

11.5 mg

Active Ingredient (in each pop)

Pectin

11.5 mg

Active ingredient (in each pop)

Pectin

11.5 mg

Active Ingredient (in each pop)

Pectin

11.5 mg

Active Ingredient (in each pop)

Pectin

11.5 mg

Active Ingredient (in each pop)

Pectin

11.5 mg

Active Ingredient (in each pop)

Pectin

11.5 mg

Active Ingredient (in each pop)

Pectin

11.5 mg

Active Ingredient (in each pop)

Pectin

11.5 mg

Active ingredient (in each pop) Calcium carbonate 200 mg (calcium 80 mg)

Active ingredient (in each pop) Calcium carbonate 200 mg (calcium 80 mg)

Active

Ingredient (in each pop) Calcium carbonate 200mg (calcium 80mg)

Active

Ingredient (in each pop) Calcium carbonate 200mg (calcium 80mg)

Active

Ingredient (in each drop)

Pectin

11.5 mg

Active Ingredient (in each drop)

Pectin

11.5 mg

Active Ingredient (in each drop)

Pectin

11.5 mg

Active Ingredient (in each drop)

Pectin

11.5 mg

Active Ingredient (in each drop)

Pectin

11.5 mg

Active Ingredient (in each drop)

Pectin

11.5 mg

Active Ingredient (in each drop)

Pectin

11.5 mg

Inactive ingredients Watermelon: citric acid, organic apple juice concentrate, organic blackberry juice concentrate, organic blueberry juice concentrate, organic cane sugar, organic cherry juice concentrate, organic cranberry juice concentrate, organic elderberry juice concentrate, organic grape juice concentrate, organic honey, organic pear juice concentrate, organic raspberry juice concentrate, organic raspberry powder, organic rice syrup, organic strawberry powder, organic watermelon flavor. Strawberry: citric acid, organic apple juice concentrate, organic cane sugar, organic elderberry juice concentrate, organic flavor, organic honey, organic orange juice concentrate, organic pear juice concentrate, organic raspberry powder, organic rice syrup, organic strawberry juice concentrate, organic strawberry powder.

Orange

Mango: citric acid, organic apple juice concentrate, organic blackberry juice concentrate, organic blueberry juice concentrate, organic cane sugar, organic cherry juice concentrate, organic cranberry juice concentrate, organic elderberry juice concentrate, organic honey, organic mango powder, organic orange juice concentrate, organic pear juice concentrate, organic raspberry juice concentrate, organic rice syrup

Inactive ingredients citric acid, organic cane sugar, organic honey, organic raspberry flavor, organic raspberry juice concentrate, organic raspberry juice powder, organic rice syrup, organic vegetable juice (color)

Inactive ingredients citric acid, organic cane sugar, organic cherry juice concentrate, organic honey, organic natural flavor, organic rice syrup, organic strawberry juice concentrate, organic strawberry powder, tart cherry powder

Inactive ingredients Watermelon: citric acid, organic apple juice concentrate, organic blackberry juice concentrate, organic blueberry juice concentrate, organic cane sugar, organic cherry juice concentrate, organic cranberry juice concentrate, organic elderberry juice concentrate, organic grape juice concentrate, organic honey, organic pear juice concentrate, organic raspberry juice concentrate, organic raspberry powder, organic rice syrup, organic strawberry powder, organic watermelon flavor Strawberry: citric acid, organic apple juice concentrate, organic cane sugar, organic elderberry juice concentrate, organic flavor, organic honey, organic orange juice concentrate, organic pear juice concentrate, organic raspberry powder, organic rice syrup, organic strawberry juice concentrate, organic strawberry powder Birthday Cake: organic cane sugar, organic flavors, organic honey, organic rice syrup.

Mixed

Berry: citric acid, organic apple juice concentrate, organic blackberry juice concentrate, organic blueberry juice concentrate, organic cane sugar, organic cherry juice concentrate, organic cranberry juice concentrate, organic elderberry juice concentrate, organic flavor, organic honey, organic pear juice concentrate, organic raspberry juice concentrate, organic raspberry powder, organic rice syrup.

Inactive ingredients Watermelon: citric acid, organic apple juice concentrate, organic blackberry juice concentrate, organic blueberry juice concentrate, organic cane sugar, organic cherry juice concentrate, organic cranberry juice concentrate, organic elderberry juice concentrate, organic flavor, organic grape juice concentrate, organic honey, organic pear juice concentrate, organic raspberry juice concentrate, organic raspberry powder, organic rice syrup, organic strawberry powder, organic watermelon flavor. Strawberry: citric acid, organic apple juice concentrate, organic cane sugar, organic elderberry juice concentrate, organic flavors, organic honey, organic orange juice concentrate, organic pear juice concentrate, organic raspberry powder, organic rice syrup, organic strawberry juice concentrate, organic strawberry powder.

Orange

Mango: citric acid, organic apple juice concentrate, organic blackberry juice concentrate, organic blueberry juice concentrate, organic cane sugar, organic cherry juice concentrate, organic cranberry juice concentrate, organic elderberry juice concentrate, organic flavor, organic honey, organic mango powder, organic orange juice concentrate, organic pear juice concentrate, organic raspberry juice concentrate, organic rice syrup.

Inactive ingredients Watermelon: citric acid, organic apple juice concentrate, organic blackberry juice concentrate, organic blueberry juice concentrate, organic cane sugar, organic cherry juice concentrate, organic cranberry juice concentrate, organic elderberry juice concentrate, organic flavor, organic grape juice concentrate, organic honey, organic pear juice concentrate, organic raspberry juice concentrate, organic raspberry powder, organic rice syrup, organic strawberry powder, organic watermelon flavor. Strawberry: citric acid, organic apple juice concentrate, organic cane sugar, organic elderberry juice concentrate, organic flavors, organic honey, organic orange juice concentrate, organic pear juice concentrate, organic raspberry powder, organic rice syrup, organic strawberry juice concentrate, organic strawberry powder.

Orange

Mango: citric acid, organic apple juice concentrate, organic blackberry juice concentrate, organic blueberry juice concentrate, organic cane sugar, organic cherry juice concentrate, organic cranberry juice concentrate, organic elderberry juice concentrate, organic flavor, organic honey, organic mango powder, organic orange juice concentrate, organic pear juice concentrate, organic raspberry juice concentrate, organic rice syrup

Inactive ingredients Watermelon: citric acid, organic apple juice concentrate, organic blackberry juice concentrate, organic blueberry juice concentrate, organic cane sugar, organic cherry juice concentrate, organic cranberry juice concentrate, organic elderberry juice concentrate, organic flavor, organic grape juice concentrate, organic honey, organic pear juice concentrate, organic raspberry juice concentrate, organic raspberry powder, organic rice syrup, organic strawberry powder, organic watermelon flavor. Strawberry: citric acid, organic apple juice concentrate, organic cane sugar, organic elderberry juice concentrate, organic flavors, organic honey, organic orange juice concentrate, organic pear juice concentrate, organic raspberry powder, organic rice syrup, organic strawberry juice concentrate, organic strawberry powder.

Orange

Mango: citric acid, organic apple juice concentrate, organic blackberry juice concentrate, organic blueberry juice concentrate, organic cane sugar, organic cherry juice concentrate, organic cranberry juice concentrate, organic elderberry juice concentrate, organic flavor, organic honey, organic mango powder, organic orange juice concentrate, organic pear juice concentrate, organic raspberry juice concentrate, organic rice syrup

Inactive ingredients Watermelon : citric acid, organic apple juice concentrate, organic blackberry juice concentrate, organic blueberry juice concentrate, organic cane sugar, organic cherry juice concentrate, organic cranberry juice concentrate, organic elderberry juice concentrate, organic grape juice concentrate, organic honey, organic pear juice concentrate, organic raspberry juice concentrate, organic raspberry powder, organic rice syrup, organic strawberry powder, organic watermelon flavor. Strawberry : citric acid, organic apple juice concentrate, organic cane sugar, organic elderberry juice concentrate, organic flavor, organic honey, organic orange juice concentrate, organic pear juice concentrate, organic raspberry powder, organic rice syrup, organic strawberry juice concentrate, organic strawberry powder.

Orange

Mango : citric acid, organic apple juice concentrate, organic blackberry juice concentrate, organic blueberry juice concentrate, organic cane sugar, organic cherry juice concentrate, organic cranberry juice concentrate, organic elderberry juice concentrate, organic honey, organic mango powder, organic orange juice concentrate, organic pear juice concentrate, organic raspberry juice concentrate, organic rice syrup

Inactive ingredients Watermelon : citric acid, organic apple juice concentrate, organic blackberry juice concentrate, organic blueberry juice concentrate, organic cane sugar, organic cherry juice concentrate, organic cranberry juice concentrate, organic elderberry juice concentrate, organic grape juice concentrate, organic honey, organic pear juice concentrate, organic raspberry juice concentrate, organic raspberry powder, organic rice syrup, organic strawberry powder, organic watermelon flavor. Strawberry : citric acid, organic apple juice concentrate, organic cane sugar, organic elderberry juice concentrate, organic flavor, organic honey, organic orange juice concentrate, organic pear juice concentrate, organic raspberry powder, organic rice syrup, organic strawberry juice concentrate, organic strawberry powder.

Orange

Mango : citric acid, organic apple juice concentrate, organic blackberry juice concentrate, organic blueberry juice concentrate, organic cane sugar, organic cherry juice concentrate, organic cranberry juice concentrate, organic elderberry juice concentrate, organic honey, organic mango powder, organic orange juice concentrate, organic pear juice concentrate, organic raspberry juice concentrate, organic rice syrup

Inactive ingredients Watermelon: citric acid, organic apple juice concentrate, organic blackberry juice concentrate, organic blueberry juice concentrate, organic cane sugar, organic cherry juice concentrate, organic cranberry juice concentrate, organic elderberry juice concentrate, organic flavor, organic grape juice concentrate, organic honey, organic pear juice concentrate, organic raspberry juice concentrate, organic raspberry powder, organic rice syrup, organic strawberry powder, organic watermelon flavor Strawberry: citric acid, organic apple juice concentrate, organic cane sugar, organic elderberry juice concentrate, organic flavors, organic honey, organic orange juice concentrate, organic pear juice concentrate, organic raspberry powder, organic rice syrup, organic strawberry juice concentrate, organic strawberry powder Orange Mango: citric acid, organic apple juice concentrate, organic blackberry juice concentrate, organic blueberry juice concentrate, organic cane sugar, organic cherry juice concentrate, organic cranberry juice concentrate, organic elderberry juice concentrate, organic flavor, organic honey, organic mango powder, organic orange juice concentrate, organic pear juice concentrate, organic raspberry juice concentrate, organic rice syrup Mixed Berry: citric acid, organic apple juice concentrate, organic blackberry juice concentrate, organic blueberry juice concentrate, organic cane sugar, organic cherry juice concentrate, organic cranberry juice concentrate, organic elderberry juice concentrate, organic flavor, organic honey, organic pear juice concentrate, organic raspberry juice concentrate, organic raspberry powder, organic rice syrup

Inactive ingredients citric acid, organic apple juice concentrate, organic blackberry juice concentrate, organic blueberry juice concentrate, organic cane sugar, organic cherry juice concentrate, organic cranberry juice concentrate, organic elderberry juice concentrate, organic flavor, organic grape juice concentrate, organic honey, organic pear juice concentrate, organic raspberry juice concentrate, organic raspberry powder, organic rice syrup, organic strawberry powder, organic watermelon flavor

Inactive ingredients citric acid, organic apple juice concentrate, organic cane sugar, organic elderberry juice concentrate, organic flavors, organic honey, organic orange juice concentrate, organic pear juice concentrate, organic raspberry powder, organic rice syrup, organic strawberry juice concentrate, organic strawberry powder

Inactive ingredients citric acid, organic apple juice concentrate, organic cane sugar, organic elderberry juice concentrate, organic flavors, organic honey, organic orange juice concentrate, organic pear juice concentrate, organic raspberry powder, organic rice syrup, organic strawberry juice concentrate, organic strawberry powder

Inactive ingredients citric acid, organic apple juice concentrate, organic cane sugar, organic elderberry juice concentrate, organic flavors, organic honey, organic orange juice concentrate, organic pear juice concentrate, organic raspberry powder, organic rice syrup, organic strawberry juice concentrate, organic strawberry powder

Inactive ingredients Citric acid, organic apple juice concentrate, organic blackberry juice concentrate, organic blueberry juice concentrate, organic cane sugar, organic cherry juice concentrate, organic cranberry juice concentrate, organic elderberry juice concentrate, organic flavor, organic honey, organic mango powder, organic orange juice concentrate, organic pear juice concentrate, organic raspberry juice concentrate, organic rice syrup

Inactive ingredients citric acid, organic apple juice concentrate, organic blackberry juice concentrate, organic blueberry juice concentrate, organic cane sugar, organic cherry juice concentrate, organic cranberry juice concentrate, organic elderberry juice concentrate, organic flavor, organic honey, organic pear juice concentrate, organic raspberry juice concentrate, organic raspberry powder, organic rice syrup

Inactive ingredients citric acid, organic apple juice concentrate, organic blackberry juice concentrate, organic blueberry juice concentrate, organic cane sugar, organic cherry juice concentrate, organic cranberry juice concentrate, organic elderberry juice concentrate, organic flavor, organic honey, organic pear juice concentrate, organic raspberry juice concentrate, organic raspberry powder, organic rice syrup

Inactive ingredients citric acid, organic apple juice concentrate, organic blackberry juice concentrate, organic blueberry juice concentrate, organic cane sugar, organic cherry juice concentrate, organic cranberry juice concentrate, organic elderberry juice concentrate, organic flavor, organic honey, organic pear juice concentrate, organic raspberry juice concentrate, organic raspberry powder, organic rice syrup

Inactive ingredients citric acid, organic apple juice concentrate, organic blackberry juice concentrate, organic blueberry juice concentrate, organic cane sugar, organic cherry juice concentrate, organic cranberry juice concentrate, organic elderberry juice concentrate, organic flavor, organic honey, organic pear juice concentrate, organic raspberry juice concentrate, organic raspberry powder, organic rice syrup

Inactive ingredients citric acid, organic apple juice concentrate, organic blackberry juice concentrate, organic blueberry juice concentrate, organic cane sugar, organic cherry juice concentrate, organic cranberry juice concentrate, organic elderberry juice concentrate, organic flavor, organic honey, organic pear juice concentrate, organic raspberry juice concentrate, organic raspberry powder, organic rice syrup

Inactive ingredients organic cane sugar, organic flavors, organic honey, organic rice syrup, organic sprinkles (organic sugar, organic corn starch, organic flavor, natural colors).

Inactive ingredients carnauba wax, corn starch (NGMO), organic cane sugar, organic flavors, organic honey, organic rice syrup, spirulina extract [color], turmeric [color], and vegetable juice concentrate (extracts of beet, beta-carotene (from carrots), paprika, radish) [color]

Inactive ingredients carnauba wax, corn starch (NGMO), organic cane sugar, organic flavors, organic honey, organic rice syrup, spirulina extract [color], turmeric [color], and vegetable juice concentrate (extracts of beet, beta-carotene (from carrots), paprika, radish) [color]

Inactive ingredients carnauba wax, corn starch (NGMO), organic cane sugar, organic flavors, organic honey, organic rice syrup, spirulina extract [color], turmeric [color], and vegetable juice concentrate (extracts of beet, beta-carotene (from carrots), paprika, radish) [color]

Inactive ingredients carnauba wax, corn starch (NGMO), organic cane sugar, organic flavors, organic honey, organic rice syrup, spirulina extract [color], turmeric [color], and vegetable juice concentrate (extracts of beet, beta-carotene (from carrots), paprika, radish) [color]

Inactive ingredients Apple: organic apple flavor, organic apple juice concentrate, organic apple powder, organic cane sugar, organic honey, organic rice syrup. Grape: organic cane sugar, organic grape flavor, organic grape juice concentrate, organic honey, organic rice syrup.

Inactive ingredients Apple: organic apple flavor, organic apple juice concentrate, organic apple powder, organic cane sugar, organic honey, organic rice syrup. Grape: organic cane sugar, organic grape flavor, organic grape juice concentrate, organic honey, organic rice syrup.

Inactive ingredients Apple: organic apple flavor, organic apple juice concentrate, organic apple powder, organic cane sugar, organic honey, organic rice syrup. Grape: organic cane sugar, organic grape flavor, organic grape juice concentrate, organic honey, organic rice syrup

Inactive ingredients Apple: organic apple flavor, organic apple juice concentrate, organic apple powder, organic cane sugar, organic honey, organic rice syrup. Grape: organic cane sugar, organic grape flavor, organic grape juice concentrate, organic honey, organic rice syrup

Inactive ingredients organic cane sugar, organic honey, organic natural flavors, organic rice syrup

Inactive ingredients organic cane sugar, organic honey, organic natural flavors, organic rice syrup

Inactive ingredients citric acid, organic cane sugar, organic honey, organic lemon flavor, organic lemon juice concentrate, organic lemon powder, organic raspberry flavor, organic raspberry juice concentrate, organic raspberry powder, organic rice syrup, organic strawberry juice concentrate, organic vegetable juice concentrate (carrot, radish)

Inactive ingredients citric acid, organic cane sugar, organic honey, organic lemon flavor, organic lemon juice concentrate, organic lemon powder, organic raspberry flavor, organic raspberry juice concentrate, organic raspberry powder, organic rice syrup, organic strawberry juice concentrate, organic vegetable juice concentrate (carrot, radish)

Inactive ingredients citric acid, organic apple juice concentrate, organic cane sugar, organic grape juice concentrate, organic honey, organic mint flavor, organic raspberry powder, organic rice syrup, organic strawberry powder, organic vegetable juice concentrate (carrot, radish), organic watermelon flavor, organic wildberry juice concentrate

Inactive ingredients citric acid, organic apple juice concentrate, organic cane sugar, organic grape juice concentrate, organic honey, organic mint flavor, organic raspberry powder, organic rice syrup, organic strawberry powder, organic vegetable juice concentrate (carrot, radish), organic watermelon flavor, organic wildberry juice concentrate

Inactive ingredients citric acid, organic apple juice concentrate, organic cane sugar, organic honey, organic lemon flavor, organic lemon juice concentrate, organic lemon powder, organic raspberry powder, organic rice syrup, organic strawberry flavor, organic strawberry juice concentrate, organic strawberry powder, organic vegetable juice concentrate (carrot, radish)