Label: CHEWABLE STOMACH RELIEF- bismuth subsalicylate tablet, chewable
- NDC Code(s): 41415-124-30
- Packager: PUBLIX SUPER MARKETS INC,
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 17, 2022
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- SPL UNCLASSIFIED SECTION
- Active ingredient (in each chewable tablet)
- Purpose
- Uses
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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 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
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- allergic to salicylate (including aspirin)
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- taking other salicylate products
Ask a doctor or pharmacist 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
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- adults and children 12 years and over: 2 tablets every 1/2 to 1 hour as needed
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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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- drink plenty of clear fluids to help prevent dehydration caused by diarrhea
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- children under 12 years: ask a doctor
- Other information
- Inactive ingredients
- Questions or comments?
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PRINCIPAL DISPLAY PANEL
Compare to active ingredient in Pepto-Bismol® Chewable Tablets*
Pink bismuth chewable tablets
Original flavor
BISMUTH SUBSALICYLATE 262 mg
ANTIDIARRHEAL/UPSET STOMACH RELIEVER
Soothing relief for:
- •
- Heartburn
- •
- Indigestion
- •
- Upset Stomach
- •
- Nausea Diarrhea
30 CHEWABLE TABLETS
DO NOT USE IF INDIVIDUAL BLISTER COMPARTMENTS ARE TORN OR OPEN
*This product is not manufactured or distributed by Procter & Gamble Inc., the distributor of Pepto-Bismol®
DISTRIBUTED BY PUBLIX SUPER MARKETS, INC.
3300 PUBLIX CORPORATE PARKWAY
LAKELAND, FL 33811
Publix.com
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INGREDIENTS AND APPEARANCE
CHEWABLE STOMACH RELIEF
bismuth subsalicylate tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41415-124 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 (light-pink) Score no score Shape ROUND Size 16mm Flavor WINTERGREEN Imprint Code RP124 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41415-124-30 5 in 1 CARTON 06/30/2017 1 6 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part335 06/30/2017 Labeler - PUBLIX SUPER MARKETS INC, (006922009)