Upset Stomach Relief-bismuth Subsalicylate 262 Mg Capsule, Liquid Filled
FDA Label NDC 72090-053

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pioneer Life Sciences, Llc for the product Upset Stomach Relief-bismuth Subsalicylate 262 Mg (NDC 72090-053). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each softgel), purpose, uses, warnings, directions, other information, inactive ingredients, questions or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Softgel)

Bismuth subsalicylate 262 mg

Purpose

Upset stomach reliever and antidiarrheal

Uses

relieves:
■ travelers' diarrhea ■ diarrhea ■ upset stomach due to overindulgence in food and drink, including ■ heartburn ■ indigestion ■ nausea ■ gas ■ belching ■ fullness

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.

Allergy alert: Contains salicylate.Do not take if you are ■ allergic to salicylates (including aspirin) ■ taking other salicylate products

Directions

■ swallow with water, do not chew
■ adults and children 12 years and over:
■ 2 softgels every ½ hour or 4 softgels every hour as needed for diarrhea
■ 2 softgels every ½ hour to 1 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
■ do not exceed 8 doses (16 softgels) 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

Other Information

■ each softgel contains:
■ salicylate 99 mg
■ low sodium
■ do not exceed 25°C

Inactive Ingredients

Polyethylene Glycol-400, Polysorbate 80, Soya Lecithin, Povidone (PVPK 30), Gelatin, Glycerin, Sorbitol Sorbitan Solution, D & C Red 33 , Titanium Dioxide, Purified Water

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