Otc - Active Ingredient
Active ingredient (in each tablet)
Bismuth subsalicylate 262 mg
The following Structured Product Label (SPL) was submitted to the FDA by Dolgencorp, Inc. for the product Regular Strength Stomach Relief (NDC 55910-204). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredient (in each tablet)
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:
o heartburn
o indigestion
o nausea
o gas
o belching
o 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
Do not use if you have
• an ulcer
• a bleeding problem
• bloody or black stool
Ask a doctor before use if you have
• fever
• mucus in the stool
Ask a doctor or pharmacist before use if you are taking any drug for
• anticoagulation (thinning the blood)
• diabetes
• gout
• arthritis
When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur
Stop use and ask a doctor if
If pregnant or breast feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Directions
chew or dissolve in mouth
adults and children 12 years and over:
do not exceed 8 doses (16 tablets) 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
Inactive ingredients calcium carbonate, D&C red #27 lake, flavor, magnesium stearate, mannitol, povidone, saccharin sodium, talc
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