Label: CVS STOMACH RELIEF- bismuth subsalicylate tablet
- NDC Code(s): 51316-124-48
- Packager: CVS
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated September 12, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each tablet)
- Purpose
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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
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- allergic to salicylates (including aspirin)
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- taking other salicylate products
Ask a doctor before use if you are taking any drug for
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- anticoagulation (thinning of the blood)
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- diabetes
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- gout
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- arthritis
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Directions
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- chew or dissolve tablets in mouth. Do not swallow tablets whole.
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- 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
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- 2 tablets (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
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- do not exceed 8 doses (16 tablets) in 24 hours
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- use until diarrhea stops but not more than 2 days
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- children under 12 years: ask a doctor
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- drink plenty of clear fluids to help prevent dehydration caused by diarrhea
- Other information
- Inactive ingredients
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PRINCIPAL DISPLAY PANEL
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
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- Upset stomach,
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- Nausea,
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- Heartburn,
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- Indigestion,
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- Diarrhea
- Original flavor
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.
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INGREDIENTS AND APPEARANCE
CVS STOMACH RELIEF
bismuth subsalicylate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51316-124 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE, SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE 262 mg Inactive Ingredients Ingredient Name Strength D&C RED NO. 27 (UNII: 2LRS185U6K) magnesium stearate (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color PINK Score no score Shape ROUND Size 16mm Flavor Imprint Code RP124 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51316-124-48 48 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/06/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part335 08/06/2021 Labeler - CVS (062312574)