INACTIVE INGREDIENT SECTION

Carbopol 934p, Di-calcium Phosphate, Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate, D&C Red # 27, FD&C Blue # 2, FD&C Red # 40, Hypromellose, Macrogol, Polydextrose, Talc, Titanium Dioxide, Triacetin.

CLINICAL PHARMACOLOGY SECTION

HYOSCYAMINE is a parasympatholytic which relaxes smooth muscles and thus produces an antispasmodic effect. It is well absorbed from the gastrointestinal tract and is rapidly distributed throughout body tissues. Most is excreted in the urine within 12 hours, 13% to 50% being unchanged. Its biotransformation is hepatic. Its protein binding is moderate.

PHENYL SALICYLATE releases salicylate, a mild analgesic for pain.

METHENAMINE degrades in an acidic urine environment releasing formaldehyde which provides bactericidal or bacteriostatic action. It is well absorbed from the gastrointestinal tract. 70% to 90% reaches the urine unchanged at which point it is hydrolyzed if the urine is acidic. Within 24 hours it is almost completely (90%) excreted; of this amount at pH 5, approximately 20% is formaldehyde. Protein binding: some formaldehyde is bound to substances in the urine and surrounding tissues. Methenamine is freely distributed to body tissues and fluids but is not clinically significant as it does not hydrolyze at pH greater than 6.8.

METHYLENE BLUE possesses weak antiseptic properties. It is well absorbed in the gastrointestinal tract and is rapidly reduced to leukomethylene blue which is stabilized in some combination form in the urine. 75% is excreted unchanged.

MONOBASIC SODIUM PHOSPHATE helps to maintain an acid pH in the urine necessary for the degradation of methenamine.

DESCRIPTION SECTION

Each tablet contains:

Methenamine, USP ------------------------- 81.6 mg

Sodium Biphosphate, USP –------------- 40.8 mg

Phenyl Salicylate, USP --------------------- 36.2 mg

Methylene Blue, USP ----------------------- 10.8 mg

Hyoscyamine Sulfate, USP ---------------- 0.12 mg

ACKAGE LABEL PRINCIPAL DISPLAY PANEL