STOMACH RELIEF
STOMACH RELIEF is an FDA drug label for the active ingredient BISMUTH SUBSALICYLATE manufactured by Consumer Value Products, 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 20231229.
Generic: BISMUTH SUBSALICYLATE
Manufacturer: Consumer Value Products, Inc.
Product Type: HUMAN OTC DRUG
Route: ORAL
Dosage Form:
NDC: 57243-557
Application: M008
Effective: 20231229
Active Ingredients: Active ingredient (in each 30 mL dose cup or 2 tablespoons) Bismuth subsalicylate 525 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 1/2 to 1 hour as needed ■ do not exceed 8 doses (240 mL or 16 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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