ALPHA.-TOCOPHEROL: 872 Adverse Event Reports & Safety Profile

INFUVITE PEDIATRIC (multiple vitamins injection) is a sterile product consisting of two vials provided as a single dose or as a pharmacy bulk package for intravenous use intended for administration by intravenous infusion after dilution: INFUVITE PEDIATRIC (multiple vitamins injection) supplied as single dose consists of: (a)

Vial

1 (4 mL); and (b)

Vial

2 (1 mL).

Vial

1 will provide one daily dose of 1.2 mL, 2.6 mL or 4 mL and Vial 2 will provide one daily dose of 0.3 mL, 0.65 mL or 1 mL [ see Dosage and Administration ( 2.2 ) ] . INFUVITE PEDIATRIC (multiple vitamins injection) supplied as pharmacy bulk package consists of: (a)

Vial

1 (40 mL Fill in 50 mL Vial); and (b)

Vial

2 (10 mL). The mixed solution will provide many single doses [ see Dosage and Administration ( 2.2 ) ].

Each

4 mL of Vial 1 contains 10 vitamins and each 1 mL of Vial 2 contains 3 vitamins (see Table 3).

Table

3: INGREDIENTS IN INFUVITE PEDIATRIC FORMULATION Vial 1 Active Ingredient Quantity per 4 mL Ascorbic acid (Vitamin C) 80 mg Vitamin A* (as palmitate) 2,300 IU (equals 0.7 mg) Vitamin D 3 * (cholecalciferol) 400 IU (equals 10 mcg) Thiamine (Vitamin B 1 ) (as the hydrochloride) 1.2 mg Riboflavin (Vitamin B 2 ) (as riboflavin 5-phosphate sodium) 1.4 mg Pyridoxine HCl (Vitamin B 6 ) 1 mg Niacinamide 17 mg Dexpanthenol (as d -pantothenyl alcohol) 5 mg Vitamin E* ( dl -α-tocopheryl acetate) 7 IU (equals 7 mg) Vitamin K 1 * 0.2 mg *Polysorbate 80 is used to water solubilize the oil-soluble vitamins A, D, E, and K. Inactive ingredients in 4 mL of Vial 1: 50 mg polysorbate 80, sodium hydroxide and/or hydrochloric acid for pH adjustment, and water for injection.

Vial

2 Active Ingredient Quantity per 1 mL Folic acid 140 mcg Biotin 20 mcg Vitamin B 12 (cyanocobalamin) 1 mcg Inactive ingredients in 1 mL of Vial 2: 75 mg mannitol, citric acid and/or sodium citrate for pH adjustment and water for injection. INFUVITE PEDIATRIC (multiple vitamins injection) makes available a combination of oil-soluble and water-soluble vitamins in an aqueous solution, formulated for incorporation into intravenous solutions. The liposoluble vitamins A, D, E, and K have been solubilized in an aqueous medium with polysorbate 80, permitting intravenous administration of these vitamins. INFUVITE PEDIATRIC contains no more than 30 mcg/L of aluminum (combined Vials 1 and 2).

AND USAGE INFUVITE PEDIATRIC is a combination of vitamins indicated for the prevention of vitamin deficiency in pediatric patients up to 11 years of age receiving parenteral nutrition. The physician should not await the development of clinical signs of vitamin deficiency before initiating vitamin therapy. INFUVITE PEDIATRIC is a combination of vitamins indicated for the prevention of vitamin deficiency in pediatric patients up to 11 years of age receiving parenteral nutrition ( 1 )

AND ADMINISTRATION

• INFUVITE PEDIATRIC is a combination product that contains the following vitamins: ascorbic acid, vitamin A, vitamin D, thiamine, riboflavin, pyridoxine, niacinamide, dexpanthenol, vitamin E, vitamin K1, folic acid, biotin, and vitamin B12 ( 2.1 )
• INFUVITE PEDIATRIC is for administration by intravenous infusion after dilution ( 2.1 )
• Recommended daily dosage is based on patient’s actual weight ( 2.2 ):
• INFUVITE PEDIATRIC Single Dose: o Weight less than 1 kg: 1.2 mL of Vial 1 and 0.3 mL of Vial 2 o Weight 1 kg to less than 3 kg: 2.6 mL of Vial 1 and 0.65 mL Vial 2 o Weight 3 kg or greater: 4 mL of Vial 1 and 1 mL of Vial 2
• INFUVITE PEDIATRIC Pharmacy Bulk Package : o Weight less than 1 kg: 1.5 mL of combined content of Vials 1 and 2 o Weight 1 kg to less than 3 kg: 3.25 mL of combined content of Vials 1 and 2 o Weight 3 kg or greater: 5 mL of combined content of Vials 1 and 2.
• Supplemental vitamin A may be required for low-birth weight infants ( 2.2 )
• INFUVITE PEDIATRIC is supplied as a single dose and as a pharmacy bulk package:
• Single Dose consists of two vials labeled Vial 1 and Vial 2. Add one daily dose of Vial 1 and one daily dose of Vial 2 directly to at least 100 mL of intravenous dextrose or saline solution prior to intravenous use ( 2.3 )
• Pharmacy Bulk Package consists of two vials labeled Vial 1 and Vial 2. Transfer contents of Vial 2 to contents of Vial 1. Then, take 1.5 mL, 3.25 mL, or 5 mL from mixture and add to at least 100 mL of intravenous dextrose or saline solution prior to intravenous use ( 2.3 )
• After dilution in an intravenous infusion, refrigerate resulting solution unless used immediately. Use solution within 24 hours after dilution ( 2.3 )
• Monitor blood vitamin concentrations ( 2.4 )
• See Full Prescribing Information for drug incompatibilities ( 2.5 ).

2.1 Important Dosage Instructions INFUVITE PEDIATRIC is a combination product that contains the following vitamins: ascorbic acid, vitamin A, vitamin D, thiamine, riboflavin, pyridoxine, niacinamide, dexpanthenol, vitamin E, vitamin K1, folic acid, biotin, and vitamin B12 . INFUVITE PEDIATRIC is supplied as a single dose or as a pharmacy bulk package, for intravenous use intended for administration by intravenous infusion after dilution:

• INFUVITE PEDIATRIC Single Dose consists of two vials. A weight-based volume from each vial must be added directly to dextrose or saline solution prior to intravenous administration [ see Dosage and Administration ( 2.2 , 2.3 ) ].
• INFUVITE PEDIATRIC Pharmacy Bulk Package consists of two pharmacy bulk vials which must be mixed prior to use. The mixed solution will provide multiple daily doses which must be diluted prior to intravenous administration. Pharmacy bulk package of INFUVITE PEDIATRIC is intended for dispensing of single doses to multiple patients in a pharmacy admixture program and is restricted to the preparation of admixtures for infusion. [ see Dosage and Administration ( 2.2 , 2.3 ) ].

2.2 Dosage Information The recommended daily dosage volume is based on the patient&apos;s actual weight less than 1 kg, 1 kg to less than 3 kg, and 3 kg or greater. Patients with multiple vitamin deficiencies or with increased vitamin requirements may need multiple daily dosages as indicated or additional doses of individual vitamins. Supplemental vitamin A may be required for low-birth weight infants. Additional daily dosages of Vitamin E in infants are not recommended <span class="opacity-50 text-xs">[see Warnings and Precautions ( 5.8 )]</span>.

Infuvite Pediatric

Single Dose (see Table 1): One daily dose of Vial 1 (1.2 mL, 2.6 mL or 4 mL) and one daily dose of Vial 2 (0.3 mL, 0.65 mL or 1 mL) based on the patient’s weight are added directly to a specified volume of an intravenous fluid [ see Dosage and Administration ( 2.3 ) ] (see Table 1).

Table

1: Recommended Weight-Based Dosage of INFUVITE PEDIATRIC Single Dose Less than 1 kg 1 kg to less than 3 kg 3 kg or greater Daily Dosage Volume – Vial 1 1.2 mL 2.6 mL 4 mL Ascorbic acid (Vitamin C) 24 mg 52 mg 80 mg Vitamin A (as palmitate) 690 IU (equals 0.2 mg) 1495 IU (equals 0.5 mg) 2,300 IU (equals 0.7 mg) Vitamin D 3 (cholecalciferol) 120 IU (equals 3 mcg) 260 IU (equals 7 mc g) 400 IU (equals 10 mcg) Thiamine (Vitamin B 1 ) (as the hydrochloride) 0.4 mg 0.8 mg 1.2 mg Riboflavin (Vitamin B 2 ) (as riboflavin 5-phosphate sodium) 0.4 mg 0.9 mg 1.4 mg Pyridoxine HCl (Vitamin B 6 ) 0.3 mg 0.7 mg 1 mg Niacinamide 5.1 mg 11.1 mg 17 mg Dexpanthenol (as d -pantothenyl alcohol) 1.5 mg 3.3 mg 5 mg Vitamin E ( dl -α-tocopheryl acetate)

2.1 IU (equals 2 mg)

4.6 IU (equals 5 mg) 7 IU (equals 7 mg) Vitamin K 1 0.1 mg 0.1 mg 0.2 mg Daily Dosage Volume – Vial 2 0.3 mL 0.65 mL 1 mL Folic acid 42 mcg 91 mcg 140 mcg Biotin 6 mcg 13 mcg 20 mcg Vitamin B12 (cyanocobalamin) 0.3 mcg 0.7 mcg 1 mcg INFUVITE PEDIATRIC Pharmacy Bulk Package (see Table 2): The recommended daily dosage volume of combined content of vials 1 and 2 (1.5 mL, 3.25 mL or 5 mL) is based on the patient’s weight and then added directly to the specific volume of an intravenous fluid [ see Dosage and Administration ( 2.3 ) ].

Table

2: Recommended Weight-Based Dosage of INFUVITE PEDIATRIC Pharmacy Bulk Package Less than 1 kg 1 kg to less than 3 kg 3 kg or greater Daily Dosage Volume(combined contents of Vial 1 and Vial 2) 1.5 mL 3.25 mL 5 mL Ascorbic acid (Vitamin C) 24 mg 52 mg 80 mg Vitamin A (as palmitate) 690 IU (equals 0.2 mg) 1495 IU (equals 0.5 mg) 2,300 IU (equals 0.7 mg) Vitamin D 3 (cholecalciferol) 120 IU (equals 3 mcg) 260 IU (equals 7 mc g) 400 IU (equals 10 mcg) Thiamine (Vitamin B 1 ) (as the hydrochloride) 0.4 mg 0.8 mg 1.2 mg Riboflavin (Vitamin B 2 ) (as riboflavin 5-phosphate sodium) 0.4 mg 0.9 mg 1.4 mg Pyridoxine HCl (Vitamin B 6 ) 0.3 mg 0.7 mg 1 mg Niacinamide 5.1 mg 11.1 mg 17 mg Dexpanthenol (as d -pantothenyl alcohol) 1.5 mg 3.3 mg 5 mg Vitamin E ( dl -α-tocopheryl acetate)

2.1 IU (equals 2 mg)

4.6 IU (equals 5 mg) 7 IU (equals 7 mg) Vitamin K 1 0.1 mg 0.1 mg 0.2 mg Folic acid 42 mcg 91 mcg 140 mcg Biotin 6 mcg 13 mcg 20 mcg Vitamin B12 (cyanocobalamin) 0.3 mcg 0.7 mcg 1 mcg

2.3 Preparation and Administration Instructions Do not administer INFUVITE PEDIATRIC as a direct, undiluted intravenous injection as it may cause dizziness, faintness, and possible tissue irritation.

Infuvite Pediatric

Single Dose:

• Use only in a suitable work area such as a laminar flow hood (or an equivalent clean air compounding area). Add one weight-based dose of Vial 1 (1.2 mL, 2.6 mL or 4 mL) and one weight-based dose of Vial 2 (0.3 mL, 0.65 mL or 1 mL) directly to at least 100 mL of intravenous dextrose or saline solution.
• Discard unused portion.
• Visually inspect for particulate matter and discoloration prior to administration.
• After INFUVITE PEDIATRIC is diluted in an intravenous infusion, refrigerate the resulting solution unless it is to be used immediately, and use the solution within 24 hours after dilution.
• Minimize exposure to light because some of the vitamins in INFUVITE PEDIATRIC, particularly A, D and riboflavin, are light sensitive.

Infuvite Pediatric

Pharmacy Bulk Package :

• Use only in a suitable work area such as a laminar flow hood (or an equivalent clean air compounding area).
• Transfer the contents of Vial 2 (10 mL of solution) into the contents of Vial 1 (40 mL of solution). The mixed solution (50 mL) will provide thirty-three 1.5 mL single doses, fifteen 3.25 mL single doses or ten 5 mL single doses.
• Each bulk vial closure shall be penetrated only one time with a suitable sterile transfer device or dispensing set that allows measured dispensing of the contents.
• Once the closure system has been penetrated, complete dispensing from the pharmacy bulk vial should be completed within 4 hours. The mixed solution may be refrigerated and stored for up to 4 hours.
• Discard unused portion.
• Visually inspect for particulate matter and discoloration prior to administration.
• Add one dose directly to at least 100 mL of intravenous dextrose or saline solution for each patient.
• After INFUVITE PEDIATRIC is diluted in an intravenous infusion, refrigerate the resulting solution unless it is to be used immediately, and use the solution within 24 hours after dilution.
• Minimize exposure to light because some of the vitamins in INFUVITE PEDIATRIC, particularly A, D and riboflavin, are light sensitive.

2.4 Monitoring Vitamin Blood Levels Blood vitamin concentrations should be monitored to ensure maintenance of adequate levels, particularly in patients receiving parenteral multivitamins as the only source of vitamins for long periods of time.

2.5 Drug Incompatibilities

• INFUVITE PEDIATRIC is not physically compatible with moderately alkaline solutions such as a sodium bicarbonate solution and other alkaline drugs such as acetazolamide sodium, aminophylline, ampicillin sodium, tetracycline HCl and chlorothiazide sodium.
• Folic acid is unstable in the presence of calcium salts such as calcium gluconate.
• Vitamin A and thiamine in INFUVITE PEDIATRIC may react with bisulfite solutions such as sodium bisulfite or vitamin K bisulfite.
• Do not add INFUVITE PEDIATRIC directly to intravenous fat emulsions.
• Consult appropriate references for additional listings of physical and chemical compatibility of solutions and drugs with the vitamin infusion when needed. If incompatibilities are identified, avoid admixture or Y-site administration with vitamin solutions.

CONTRAINDICATIONS: Vitafol ® One is contraindicated in patients with hypersensitivity to any of its components or color additives. Folic acid is contraindicated in patients with untreated and uncomplicated pernicious anemia, and in those with anaphylactic sensitivity to folic acid. Iron therapy is contraindicated in patients with hemochromatosis and patients with iron storage disease or the potential for iron storage disease due to chronic hemolytic anemia (e.g., inherited anomalies of hemoglobin structure or synthesis and/or red cell enzyme deficiencies, etc.), pyridoxine responsive anemia, or cirrhosis of the liver. Cyanocobalamin is contraindicated in patients with sensitivity to cobalt or to cyanocobalamin (vitamin B-12).

REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling.

• Allergic reactions to thiamine [ see Warnings and Precautions ( 5.2 ) ].
• Hypervitaminosis A [ see Warnings and Precautions ( 5.3 ) ] The following adverse reactions have been identified during postapproval use of INFUVITE PEDIATRIC. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Dermatologic: rash, erythema, pruritis CNS: headache, dizziness, agitation, anxiety Ophthalmic: diplopia Adverse reactions have included anaphylaxis, rash, erythema, pruritis, headache, dizziness, agitation, anxiety, diplopia ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

AND PRECAUTIONS

• Risk of Aluminum Toxicity: For at risk patients (renal failure or those with prolonged therapy), consider periodic monitoring of aluminum levels ( 5.1 )
• Allergic Reactions: To thiamine may occur ( 5.2 )
• Hypervitaminosis A : Patients with renal failure or liver disease may be at higher risk ( 5.3 )
• Decreased Anticoagulant Effect of Warfarin: Monitor INR ( 5.4 , 7.1 )
• Interferes with Megaloblastic Anemia Diagnosis: Avoid during testing for this disorder ( 5.5 )
• Risk of Vitamin Deficiencies or Excesses: Monitor blood vitamin concentrations ( 5.6 )
• False Negative Urine Glucose Tests: Due to vitamin C ( 5.7 )
• Risk of Vitamin E Toxicity: Additional oral and parenteral vitamin E may result in elevated vitamin E blood concentrations in infants ( 5.8 )
• Low Vitamin A Levels: Monitor vitamin A levels ( 5.9 )
• Risk of E-Ferol Syndrome: Due to polysorbates ( 5.10 )

5.1 Aluminum Toxicity INFUVITE PEDIATRIC contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration in pediatric patients with renal impairment. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solution, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration. To prevent aluminum toxicity periodically monitor aluminum levels with prolonged parenteral administration of INFUVITE PEDIATRIC.

5.2 Allergic Reactions to Thiamine Allergic reactions such as urticaria, shortness of breath, wheezing and angioedema have been reported following intravenous administration of thiamine, which is found in INFUVITE PEDIATRIC. There have been rare reports of anaphylaxis following intravenous doses of thiamine. No fatal anaphylaxis associated with INFUVITE PEDIATRIC has been reported. 5.3. Hypervitaminosis A Hypervitaminosis A, manifested by nausea, vomiting, headache, dizziness, blurred vision has been reported in patients with renal failure receiving 1.5 mg/day retinol and in patients with liver disease. Therefore, supplementation of renal failure patients and patients with liver disease with vitamin A, an ingredient found in INFUVITE PEDIATRIC, should be undertaken with caution [ see Use in Specific Populations ( 8.6 , 8.7 ) ]. Blood levels of Vitamin A should be monitored periodically.

5.4 Decreased Anticoagulant Effect of Warfarin INFUVITE PEDIATRIC contains Vitamin K which may decrease the anticoagulant action of warfarin. In patients who are on warfarin anticoagulant therapy receiving INFUVITE PEDIATRIC monitor blood levels of prothrombin/INR to determine if dose of warfarin needs to be adjusted.

5.5 Interference with Diagnosis of Megaloblastic Anemia INFUVITE PEDIATRIC contains folic acid and cyanocobalamin which can mask serum deficiencies of folic acid and cyanocobalamin in patients with megaloblastic anemia. Avoid the use of INFUVITE PEDIATRICS in patients with suspected or diagnosed megaloblastic anemia prior to blood sampling for the detection of the folic acid and cyanocobalamin deficiencies.

5.6 Potential to Develop Vitamin Deficiencies or Excesses In patients receiving parenteral multivitamins such as with INFUVITE PEDIATRIC, blood vitamin concentrations should be periodically monitored to determine if vitamin deficiencies or excesses are developing. INFUVITE PEDIATRIC may not correct long-standing specific vitamin deficiencies. The administration of additional doses of specific vitamins may be required [ see Dosage and Administration ( 2.2 ) ].

5.7 Interference with Urine Glucose Testing INFUVITE PEDIATRIC contains vitamin C which is also known as ascorbic acid. Ascorbic acid in the urine may cause false negative urine glucose results.

5.8 Vitamin E Overdose in Infants Receiving Additional Vitamin E Additional vitamin E supplementations of patients receiving INFUVITE PEDIATRIC may result in elevated blood concentrations of vitamin E and potential vitamin E toxicity in infants. Avoid additional oral or parental doses of vitamin E in infants. Daily dose of INFUVITE PEDIATRIC contains adequate concentrations of vitamin E required to achieve normal blood levels of vitamin E.

5.9 Risk of Low Vitamin A Levels Lower vitamin A concentrations may occur after administration of INFUVITE PEDIATRIC due to the adherence of Vitamin A to plastic. Monitor blood vitamin A concentrations periodically. Additional administration of therapeutic doses of vitamin A may be required, especially in low-birth weight infants.

5.10 Risk of E-Ferol Syndrome in Low-Birth Weight Infants E-Ferol syndrome manifested by thrombocytopenia, renal dysfunction, hepatomegaly, cholestasis, ascites, hypotension and metabolic acidosis has been reported in low-birth weight infants following administration of polysorbates which are found in INFUVITE PEDIATRIC. No E-Ferol syndrome associated with INFUVITE PEDIATRIC has been reported.

CAUTION Do not use this product if you are allergic to any of the ingredients. Take this product at least 2 hours before or after taking any products containing calcium (including milk, yogurt, other dairy products) or aluminum/magnesium hydroxide (e.g., certain antacids/laxatives). Prolonged daily ingestion of excessive fluoride may result in varying degrees of dental fluorosis. Account for all daily sources of fluoride intake.

INTERACTIONS A number of interactions between vitamins and drugs have been reported. The following are examples of these types of interactions. Effect of INFUVITE PEDIATRIC on other drugs :

• Antibiotics: Thiamine, riboflavin, pyridoxine, niacinamide, and ascorbic acid decrease activities of erythromycin, kanamycin, streptomycin, doxycycline, and lincomycin ( 7.1 )
• Bleomycin: Ascorbic acid and riboflavin may reduce the activity of bleomycin ( 7.1 )
• Levodopa: Pyridoxine may decrease blood levels of levodopa and levodopa efficacy may decrease ( 7.1 )
• Phenytoin: Folic acid may decrease phenytoin blood levels and increase risk of seizure activity ( 7.1 )
• Methotrexate: Folic acid may decrease response to methotrexate ( 7.1 ) Effects of other drugs on INFUVITE PEDIATRIC:
• Hydralazine, Isoniazid: Concomitant administration of hydralazine or isoniazid may increase pyridoxine requirements ( 7.2 ).
• Phenytoin: May decrease folic acid concentrations ( 7.2 )

7.1 Drug Interactions Affecting Co-administered Drugs Warfarin : Vitamin K, a component of INFUVITE PEDIATRIC, antagonizes the anticoagulant action of warfarin. In patients who are co-administered warfarin and INFUVITE PEDIATRIC, blood levels of prothrombin/INR should be monitored to determine if dose of warfarin needs to be adjusted [ see Warnings and Precautions ( 5.4 ) ]. Antibiotics : Thiamine, riboflavin, pyridoxine, niacinamide, and ascorbic acid decrease antibiotic activities of erythromycin, kanamycin, streptomycin, doxycycline, and lincomycin. Bleomycin : Ascorbic acid and riboflavin inactivate bleomycin in vitro , thus the activity of bleomycin may be reduced. Levodopa : Pyridoxine may increase the metabolism of levodopa (decrease blood levels of levodopa) and decrease its efficacy. Phenytoin : Folic acid may increase phenytoin metabolism and lower the serum concentration of phenytoin resulting in increased seizure activity. Methotrexate : Folic acid may decrease a patient’s response to methotrexate therapy.

7.2 Drug Interactions Affecting Vitamin Levels Hydralazine, Isoniazid : Concomitant administration of hydralazine or isoniazid may increase pyridoxine requirements. Phenytoin : Phenytoin may decrease serum folic acid concentrations.

DESCRIPTION CitraNatal ® 90 DHA is a prescription prenatal/postnatal multivitamin/mineral tablet with Ferr-Ease ® , a patented dual-iron delivery comprising both a quick release and slow release iron, and a capsule of an essential fatty acid. The prenatal vitamin is a white, oval multivitamin/mineral tablet. The tablet is debossed “CN 90” on one side and “0821” on the other. The essential fatty acid DHA capsule is caramel colored and contains a light yellow to orange semi-solid mixture. Each prenatal tablet contains: Vitamin C (Ascorbic acid) 120 mg Calcium (Calcium citrate) 159 mg Iron (Carbonyl iron, ferrous gluconate) 90 mg Vitamin D3 (Cholecalciferol) 400 IU Vitamin E (dl-alpha tocopheryl acetate) 30 IU Thiamin (Vitamin B1) 3 mg Riboflavin (Vitamin B2) 3.4 mg Niacinamide (Vitamin B3) 20 mg Vitamin B6 (Pyridoxine HCl) 20 mg Folic Acid 1 mg Iodine (Potassium iodide) 150 mcg Zinc (Zinc oxide) 25 mg Copper (Cupric oxide) 2 mg Docusate Sodium 50 mg Each DHA gelatin capsule contains: Docosahexaenoic Acid(DHA, 40% from 750 mg Algal Oil) 300 mg Eicosapentaenoic Acid (EPA) Not more than 0.750 mg Other ingredients in DHA gelatin capsule: Gelatin, glycerin, sunflower oil, water, caramel color, tocopherols, rosemary extract, sunflower lecithin, ascorbyl palmitate.

Glycerin D-Sorbitol Solution Silica Carboxymethylcellulose Sodium Sodium Cocoyl Glycinate Mica Chitosan Xylitol Steviol Glycoside L-Menthol Glycyrrhiza Extract Sophora Flavescens Extract Scutellaria Baicalensis Root Extract Salvia Officinalis (Sage)

Extract Calendula Officinalis Flower Extract

Gentiana Lutea Root Extract Rosmarinus Officinalis (Rosemary)

Extract Aloe Barbadensis Leaf Extract

Citrus Paradisi (Grapefruit)

Seed Extract Lavandula

Angustifolia (Lavender)

Extract Propolis Extract Eucalyptus Globulus

Leaf Oil Chamaecyparis Obtusa Oil Pistacia Lentiscus (Mastic)

Gum

Anethole fravor Silver Activated Carbon Hydroxyapatite Water