Phosphasal (Page 2 of 2)

Drug interactions

because of this product’s effect on gastrointestinal motility and gastric emptying, it may decrease the absorption of other oral medications during concurrent use such as: urinary alkalizers; 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 (may reduce absorption of hyoscyamine, concurrent use with antacids may cause urine to become alkaline, reducing 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); ketoconazole (patients should be advised to take this combination at least 2 hours after ketoconazole); monoamine oxidase (MAO) inhibitors (concurrent use 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 may become blue to blue-green and the feces may be discolored as a result of the excretion of the Methylene blue.

DRUG ABUSE AND DEPENDENCE

A dependence on the use of Phosphasal tablets has not been reported and due to the nature of its ingredients, abuse of Phosphasal tablets is not expected.

OVERDOSAGE

Emesis or gastric lavage. Slow intravenous administration of physostigmine in doses of 1 to 4 mg (0.5 to 1 mg in children), repeated as needed in one to two hours to reverse severe antimuscarinic symptoms.

Administration of small doses of diazepam to control excitement and seizures. Artificial respiration with oxygen if needed for respiratory depression. Adequate hydration. Symptomatic treatment as necessary.

If overdose is suspected, contact your local poison center or emergency room immediately. US residents can contact the US National Poison Hotline at 1-800-222-1222.

HOW SUPPLIED

Phosphasal tablets are blue tablets imprinted with “SAT” on one side and “902” on opposite side. NDC 0076-0902-01, Bottle of 100 Tablets.

STORAGE

Dispense in a tight, light-resistant container as defined in the USP/NF with a child resistant closure.

Store at controlled room temperature 15°-30°C (59°-86°F).

Keep in a cool, dry place.
Keep container tightly closed.

DOSAGE AND ADMINISTRATION

Adults — one tablet orally 4 times per day followed by liberal fluid intake.

Older Children — Dosage must be individualized by physician. Not recommended for use in children six years of age or younger.

Phosphasal Bottle Label

Phosphasal
(click image for full-size original)

WARNING: Keep this and all drugs out of reach of children.

Rx Only

Phosphasal is a trademark of Stellar Pharmacal

Distributed by:
BIOCOMP PHARMA, INC.
San Antonio, Texas 78230

Manufactured for:
STELLAR PHARMACAL
Ft. Lauderdale, FL 33306

Rev. 90201-23-07/12

PHOSPHASAL
methenamine, sodium phosphate, monobasic, monohydrate, phenyl salicylate, methylene blue, and hyoscyamine sulfate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0076-0902
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (SODIUM CATION) SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 40.8 mg
PHENYL SALICYLATE (PHENYL SALICYLATE) PHENYL SALICYLATE 36.2 mg
HYOSCYAMINE SULFATE (HYOSCYAMINE) HYOSCYAMINE SULFATE 0.12 mg
METHYLENE BLUE (METHYLENE BLUE CATION) METHYLENE BLUE 10.8 mg
METHENAMINE (METHENAMINE) METHENAMINE 81.6 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
ALUMINUM OXIDE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
POLYVINYL ALCOHOL
STEARIC ACID
TALC
TITANIUM DIOXIDE
Product Characteristics
Color blue Score no score
Shape OVAL Size 12mm
Flavor Imprint Code SAT;902
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0076-0902-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 09/21/2010
Labeler — Star Pharmaceuticals, LLC (962184003)

Revised: 01/2017 Star Pharmaceuticals, LLC

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