Active Ingredient (In Each Caplet)
Bismuth subsalicylate 262 mg
Stomach Relief Tablet
FDA Label NDC 63868-691
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Association Inc for the product Stomach Relief (NDC 63868-691). 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 caplet), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Upset stomach reliever/antidiarrheal
Uses
relieves:
- travelers' diarrhea
- diarrhea
- upset stomach due to overindulgence in food and drink, including:
- belching
- indigestion
- gas
- fullness
- heartburn
- nausea
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
- diabetes
- arthritis
- anticoagulation (thinning the blood)
- gout
When Using This Product
a temporary, but harmless, darkening of the stool and/or tongue may occur.
Stop Use And Ask A Doctor If
- symptoms get worse
- ringing in the ears or loss of hearing occurs
- diarrhea lasts more than 2 days
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.
Directions
- do not take more than directed
- swallow with water; do not chew
- drink plenty of clear fluids to help prevent dehydration caused by diarrhea
- adults and children 12 years and over: 2 caplets every 1/2 to 1 hour as needed. Do not exceed 8 doses (16 caplets) in 24 hours.
- use until diarrhea stops, but not more than 2 days
- children under 12 years: ask a doctor
Other Information
- each caplet contains: calcium 20 mg, salicylate 103 mg
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- avoid excessive heat
- see end flap for expiration date and lot number
Inactive Ingredients
calcium carbonate, corn starch, D&C red #27 aluminum lake, D&C red #30 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, povidone, silicon dioxide, sodium starch glycolate, stearic acid
Questions Or Comments?
1-800-426-9391
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CHOICE
NDC 63868-691-40
*Compare to the Active Ingredient in Pepto-Bismol®
Stomach Relief
Bismuth Subsalicylate 262 mg
Upset Stomach Reliever/Antidiarrheal
Relieves Nausea, Heartburn, Indigestion,
Upset Stomach, Diarrheal
actual size
40 Caplets
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*This product is not manufactured or distributed by The Procter & Gamble Company, owner of the registered trademark Pepto-Bismol®.
50844 ORG122034610
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