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Drug Facts
Stomach Relief Tablet, Chewable
FDA Label NDC 21130-241
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Safeway for the product Stomach Relief (NDC 21130-241). 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 other, active ingredient (in each chewable tablet), purpose, uses, reye's syndrome, allergy alert, otc - do not use, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Chewable Tablet)
Bismuth subsalicylate 262 mg
Purpose
Antidiarrheal/ upset stomach reliever
Uses
relieves
▪ travelers' diarrhea▪ diarrhea▪ upset stomach due to overindulgence in food and drink, including▪ heartburn▪ indigestion▪ nausea▪ gas▪ belching▪ fullness
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 or vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.
Allergy Alert
Do not use if you are
▪ allergic to salicylate (including aspirin)▪ taking other salicylate products
Otc - Do Not Use
Do not use if you have
▪ an ulcer▪ a bleeding problem▪ bloody or black stool
Otc - Ask Doctor
Ask a doctor before use if you have
▪ fever▪ mucus in the stool
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking any drug for
▪ anticoagulation (thinning of the blood)▪ diabetes▪ gout▪ arthritis
Otc - When Using
When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur
Otc - Stop Use
Stop use and ask a doctor if
▪ symptoms get worse or last more than 2 days▪ ringing in the ears or loss of hearing occurs▪ diarrhea lasts more than 2 days
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately at 1-800-222-1222
Directions
▪ chew completely or dissolve tablets in mouth. Do not swallow tablets whole.▪ adults and children 12 years and over:▪ 2 tablets (1 dose) every ½ hour to 1 hour or 4 tablets (2 doses) every hour as needed for diarrhea▪ 2 tablets (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)▪ do not exceed 8 doses (16 tablets) in 24 hours▪ use until diarrhea stops but not more than 2 days▪ drink plenty of clear fluids to help prevent dehydration caused by diarrhea▪ children under 12 years: ask a doctor
Other Information
▪ each tablet contains: salicylate 102 mg▪ Store at room temperature▪ avoid excessive heat▪ keep this carton for future reference on full labeling
Inactive Ingredients
D&C Red No. 27, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucralose.
Questions Or Comments?
1-866-467-2748
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Compare to the active ingredient in Pepto-Bismol® Chewables*
Stomach Relief
Chewable Tablets
Upset Stomach Reliever/Antidiarrheal
Original flavor
5 Symptoms Digestive Relief:
- Heartburn
- Indigestion
- Nausea
- Upset Stomach
- Diarrhea
30 Chewable Tablets
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR OF STRIP UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
*This product is not manufactured or distributed by Procter & Gamble Inc., the distributor of Pepto-Bismol® Chewables.
Distributed by:
Stomach Relief Bismuth Subsaqlicylate (Pepto Bismol 01)
* Please review the disclaimer below.
