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Uralgic

Generic Name: methenamine, sodium biphosphate, phenyl salicylate, methylene blue, hyoscyamine
Dosage Form: tablet

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Uralgic

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

Uralgic 
methenamine, sodium biphosphate, phenyl salicylate, methylene blue, hyoscyamine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:69367-103
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
methenamine (methenamine) methenamine 81.6 mg
methylene Blue (methylene blue cation) methylene Blue 10.8 mg
Hyoscyamine sulfate (Hyoscyamine) Hyoscyamine sulfate .12 mg
phenyl salicylate (phenyl salicylate) phenyl salicylate 36.2 mg
potassium phosphate, monobasic (potassium cation) potassium phosphate, monobasic 40.8 mg
Inactive Ingredients
Ingredient Name Strength
Polydextrose  
Titanium Dioxide  
talc  
D&C RED NO. 27  
Triacetin  
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS  
magnesium stearate  
cellulose, microcrystalline  
FD&C BLUE NO. 2  
FD&C RED NO. 40  
Hypromelloses  
Polyethylene Glycols  
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)  
Product Characteristics
Color purple Score no score
Shape OVAL Size 13mm
Flavor Imprint Code WP;103
Contains         
Packaging
# Item Code Package Description
1 NDC:69367-103-04 100 TABLET in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/22/2015
Labeler - WESTMINSTER (079516651)
Revised: 02/2015
 
WESTMINSTER



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