BENZOIC ACID: 18 Adverse Event Reports & Safety Profile

DESCRIPTION Uribel® Tabs for oral administration Each tablet contains: Methenamine .........................................................................................................................81.6 mg Benzoic Acid ..........................................................................................................................9.0 mg Phenyl Salicylate ...................................................................................................................36.2 mg Methylene Blue ......................................................................................................................10.8 mg Hyoscyamine Sulfate..............................................................................................................0.12 mg HYOSCYAMINE SULFATE. [620-61-1][3(S)-endo]-α-(Hydroxymethyl)-benzeneacetic acid 8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester sulfate(2:1)(salt); 1αH, 5αH-tropan-3α-ol(-)- tropate(ester) sulfate(2:1)(salt); 3α-tropanyl S-(-)-tropate; I-tropic acid ester with tropine; I-tropine tropate. C 34 H 48 N 2 O 10 S.

Hyoscyamine

Sulfate is an alkaloid of belladonna. Exists as a white crystalline powder. Its solutions are alkaline to litmus. Affected by light, it is slightly soluble in water; freely soluble in alcohol; sparingly soluble in ether. METHENAMINE. [100-97-0] 1,3,5,7-Tetraazatricyclo [3.3.1.-1 3,7] decane; hexamethylenetetramine; HMT; HMTA; hexamine; 1,3,5,7-tetraazaadamantane hexamethyleneimine; Uritone; Urotropin. C 6 H 12 N 4 ; mol wt 140.19; C 51.40%, H 8.63%, N 39.96%. Methenamine (hexamethylenetetramine) exists as colorless, lustrous crystals or white crystalline powder. Its solutions are alkaline to litmus. Freely soluble in water, soluble in alcohol and in chloroform. METHYLENE BLUE. [61-73-4] 3,7-Bis(dimethylamino) phenothiazin-5-ium chloride; C.I.

Basic Blue

9; methylthioninium chloride; tetramethylthionine chloride; 3,7-bis(dimethylamino) phenazathionium chloride. C 16 H 18 ClN 3 S; mol wt 319.85, C 60.08%, H 5.67%, Cl 11.08%, N 13.14%, S 10.03%.

Methylene

Blue (Methylthionine chloride) exists as dark green crystals. It is soluble in water and in chloroform; sparingly soluble in alcohol. PHENYL SALICYLATE. [118-55-8] 2-Hydroxybenzoic acid phenyl ester; Salol. C 13 H 10 O 3 ; mol wt 214.22, C 72.89%, H 4.71%, O 22.41%. Made by the action of phosphorus oxychloride on a mixture of phenol and salicylic acid.

Phenyl

Salicylate exists as white crystals with a melting point of 41°-43°C. It is very slightly soluble in water and freely soluble in alcohol. BENZOIC ACID. [65-85-0] Benzenecarboxylic acid; Benzeneformic acid; Benzenemethanoic acid. C 7 H 6 O 2 ; mol wt 122.12, C 68.85%, H 4.95%, O 26.20%. Exists as white powder or crystals, scales or needles. It has a strong odor and is slightly soluble in alcohol; also soluble in volatile and fixed oils, slightly soluble in petroleum ether.

Uribel

Tabs contain inactive ingredients: Crospovidone, FD&C Blue #2, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Rice Starch, Silicon Dioxide, Sodium Starch Glycolate, Stearic Acid, Talc, and Titanium Dioxide.

Uses Temporarily relieves occasional heel discomfort often caused by daily activities and exercises. It also temporarily relieves occasional sharp localized aches, strong heel discomfort in the morning and after rest, and aggravated aches by prolonged weight-bearing activity.* *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED. This product is not intended to diagnose, treat, cure, or prevent any disease.

DOSAGE & ADMINISTRATION SECTION Directions: Children, ages 0 to 11, give 3 pellets by mouth (ages 12 and up, give 6 pellets) at bedtime or as directed by a health professioal. Under age 2, crush/dissolve pellets in purified water. Sensitive person begin with 1 pellet and gradually increase to full dose.

CONTRADICTIONS Hypersensitivity to any of the ingredients is possible. Risk benefits should be carefully considered when the following medical problems exist: cardiac disease (especially cardiac arrhythmias, congestive heart failure, coronary heart disease, and mitral stenosis); gastrointestinal tract obstructive disease; glaucoma; myasthenia gravis, acute urinary retention may be precipitated in obstructive uropathy (such as bladder neck obstruction due to prostatic hypertrophy).

Warnings and Storage: Ask a professional before use if pregnant or breastfeeding or if you have severe symptoms. Keep away from children. If you have a reaction to this product that is not positive, discontinue use. Store in a cool and dry place. *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED. This product is not intended to diagnose, treat, cure, or prevent any disease.

PRECAUTIONS Cross sensitivity and/or related problems Patients intolerant of belladonna alkaloids or salicylates may be intolerant of this medication also. Delay in gastric emptying could complicate the management of gastric ulcers. Pregnancy/Reproduction (FDA Pregnancy Category C) Hyoscyamine and methenamine cross the placenta. Studies concerning the effect of hyoscyamine and methenamine on pregnancy and reproduction have not been done in animals or humans. Thus, it is not known whether Uribel Tabs cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

Uribel

Tabs should be given to a pregnant woman only if clearly needed.

Breastfeeding

Problems in humans have not been documented; however, methenamine and traces of hyoscyamine are excreted in breast milk. Accordingly, Uribel Tabs should be given to a nursing mother with caution and only if clearly needed. Prolonged use There have been no studies to establish the safety of prolonged use in humans. No known long-term animal studies have been performed to evaluate carcinogenic potential. Pediatric use Infants and young children are especially susceptible to the toxic effect of the belladonna alkaloids. Geriatric use Use with caution in elderly patients as they may respond to usual doses of hyoscyamine with excitement, agitation, drowsiness or confusion.

Adverse Reactions

Cardiovascular: rapid heartbeat, flushing Central Nervous System: blurred vision, dizziness, drowsiness Genitourinary: difficult micturition, acute urinary retention Gastrointestinal: dry mouth, nausea and vomiting Respiratory: shortness of breath or trouble breathing Serious allergic reactions to this drug are rare. Seek immediate medical attention if you notice symptoms of a serious allergic reaction, including itching, rash, severe dizziness, swelling or trouble breathing. This medication can cause urine and sometimes stools to turn blue to blue-green. This effect is harmless and will subside after medication is stopped. Call your doctor or physician for medical advice about side effects. To report SUSPECTED ADVERSE REACTIONS, contact Mission Pharmacal at 1-800-298-1087 or FDA at 1-800-FDA-1088, www.fda.gov/medwatch. Drug interactions As a result of hyoscyamine's effects on gastrointestinal motility and gastric emptying, absorption of other oral medications may be decreased during concurrent use with this combination medication. Methylene blue inhibits a range of CYP isozymes in vitro, including 1A2, 2B6, 2C8, 2C9, 2C19, 2D6 and 3A4/5. This interaction could be more pronounced with narrow therapeutic index drugs that are metabolized by one of these enzymes (e.g., digoxin, warfarin, phenytoin, alfentanil, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus and tacrolimus). However, the clinical relevance of these in vitro interactions is unknown. Urinary alkalizers and thiazide diuretics May cause the urine to become alkaline reducing the effectiveness of methenamine by inhibiting its conversion to formaldehyde. Antimuscarinics: Concurrent use may intensify antimuscarinic effects of hyoscyamine because of secondary antimuscarinic activities of these medications. Antacids/antidiarrheals Concurrent use may reduce absorption of hyoscyamine resulting in decreased therapeutic effectiveness. Concurrent use with antacids may cause urine to become alkaline reducing the effectiveness of methenamine by inhibiting its conversion to formaldehyde. Doses of these medications should be spaced 1 hour apart from doses of hyoscyamine.

Antimyasthenics

Concurrent use with hyoscyamine may further reduce intestinal motility, therefore, caution is recommended. Ketoconazole and hyoscyamine may cause increased gastrointestinal pH. Concurrent administration with hyoscyamine may result in marked reduction in the absorption of ketoconazole. Patients should be advised to take this combination at least 2 hours after ketoconazole. Monoamine oxidase (MAO) inhibitors Concurrent use with hyoscyamine may intensify antimuscarinic side effects. Opioid (narcotic) analgesics may result in increased risk of severe constipation.

Sulfonamides

These drugs may precipitate with formaldehyde in the urine increasing the danger of crystalluria. Patients should be advised that the urine and/or stools may become blue to blue-green as a result of the excretion of methylene blue.

ACTIVE INGREDIENTS: Agnus Castus 12X, Aurum Metallicum 12X, Benzoicum Acidum 6X, Bryonia (Alba) 12X, Bufo Rana 16X, Caladium Seguinum 6X, Chimaphila Umbellata 6X, Clematis Erecta 6X, Conium Maculatum 12X, Cortisone Aceticum 8X, 12X, 30X, 200X, Hypothalamus Suis 8X, 12X, 30X, 200X, Kali Arsenicosum 15X, Lycopodium Clavatum 12X, Natrum Muriaticum 6X, 12X, 30X, 200X, Prostate (Suis) 8X, 12X, 30X, 200X), Rhododendron Chrysanthum 6X, Sabal Serrulata 6X, Selenium Metallicum 12X, Sepia 12X, Testosterone 8X, 12X, 30X, 200X, Thuja Occidentalis 12X.

INACTIVE INGREDIENT SECTION Inactive Ingredients: Gluten-free, non-GMO, organic beet-derived sucrose (lactose-free) pellets.