Stomach Relief - Maximum Strength

BISMUTH SUBSALICYLATE ORAL HUMAN OTC DRUG

Stomach Relief - Maximum Strength is an FDA drug label for the active ingredient BISMUTH SUBSALICYLATE manufactured by AptaPharma Inc. administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231230.

Generic name
BISMUTH SUBSALICYLATE
Manufacturer
AptaPharma Inc.
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
76281-538
Application
M008
Label effective
20231230

Active ingredients

Active ingredient (in each 30 mL dose cup or 2 tablespoons) Bismuth subsalicylate 1050 mg

Indications & Usage

Uses relieves ■ travelers' diarrhea ■ diarrhea ■ upset stomach due to overindulgence of food and drink including: ■ heart burn ■ indigestion ■ nausea ■ gas ■ belching

Dosage & Administration

Directions ■ Shake well before use ■ use dose cup or tablespoon (TBSP) ■ adults and children 12 years and over: 1 dose (30 mL or 2 TBSP) every 1 hour as needed ■ do not exceed 4 doses (120 mL or 8 TBSP) in 24 hours ■ use until diarrhea stops but not more than 2 days ■ children under 12 years: ask a doctor ■ drink plenty of clear fluids to help prevent dehydration caused by diarrhea

Contraindications

Not available.

Warnings

Warnings Reye's syndrome : Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Adverse Reactions

Not available.

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