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Drug Facts
Cvs Stomach Relief Tablet
FDA Label NDC 51316-124
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs for the product Cvs Stomach Relief (NDC 51316-124). 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 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 Tablet)
Bismuth subsalicylate 262 mg
Purpose
Upset stomach reliever and anti-diarrheal
Uses
relieves
- traveler’s 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 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
Otc - Do Not Use
Do not use if you have
- bloody or black stool
- an ulcer
- a bleeding problem
Otc - Ask Doctor
Ask a doctor before use if you have
- fever
- mucus in the stool
Otc - Ask Doctor/Pharmacist
Ask a doctor 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 occurs or loss of hearing occurs
- diarrhea lasts more than 2 days
Otc - Pregnancy Or Breast Feeding
If pregnant or breast feeding, 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.1-800-222-1222.
Directions
- chew or dissolve tablets in mouth. Do not swallow tablets whole.
- adults and children 12 years and older: 2 tablets (1 dose) every 1/2 hour or 4 tablets (2 dose) every hour as needed for diarrhea
- 2 tablets (1 dose) every 1/2 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
- children under 12 years: ask a doctor
- drink plenty of clear fluids to help prevent dehydration caused by diarrhea
Other Information
- each tablets contains: salicylate 102 mg
- store at room temperature
- avoid excessive heat
Inactive Ingredients
D&C Red# 27 lake, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucralose.
Questions Or Comments?
1-866-467-2748
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NDC 51316-124-48
Compare to active ingredient in Pepto-Bismol® Chewables*
Stomach Relief
Chewable tablets
Bismuth subsalicylate, Upset Stomach Reliever / Antidiarrheal
5- symptom digestive relief
- Upset stomach,
- Nausea,
- Heartburn,
- Indigestion,
- Diarrhea
48 chewable tablets
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF STRIP UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
Dist.by
*This product is not manufactured or distributed by Procter & Gamble Inc., the distributor of PEPTO-BISMOL® Chewables.
Cvs Stomach Relief Bismuth Subsalicylate (Pepto 01)
* Please review the disclaimer below.
