Label: KROGER STOMACH RELIEF- bismuth subsalicylate tablet, chewable
- NDC Code(s): 30142-324-30
- Packager: KROGER COMPANY
- 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 August 23, 2023
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- Official Label (Printer Friendly)
- Active ingredient (in each 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 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
Do not use if you have
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- an ulcer
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- a bleeding problem
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- bloody or black stool
Ask a doctor before use if you have
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- fever
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- mucus in the stool
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 completely 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 doses) 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 clear fluids to help prevent dehydration caused by diarrhea.
- Other information
- Inactive ingredients
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Principal Display
NDC# 30142-324-30
COMPARE TO the active ingredient of PEPTO-BISMOL® CHEWABLES *See side panel
CHEWABLE
Stomach Relief Tablets
Bismuth Subsalicylate 262 mg
Upset Stomach, Reliever / Antidiarrheal
5 SYMPTOM RELIEF
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- Heartburn
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- Indigestion
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- Nausea
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- Upset Stomach
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- Diarrhea
Original Flavor
30 CHEWABLE TABLETS
DISTRIBUTED BY:
THE KROGER CO.
CINCINNATI, OHIO 45202
QUALITY GUARANTEE
800-632-6900
IMPORTANT: KEEP THIS CARTON FOR FUTURE REFERENCE ON FUL LABELING.
*Pepto-Bismol® Chewable is a registered trademark of The Procter & Gamble Company, Cincinnati, OH 45202. The Procter & Gamble Company is not affiliated with The Kroger Co. or this product.
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INGREDIENTS AND APPEARANCE
KROGER STOMACH RELIEF
bismuth subsalicylate tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:30142-324 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (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 17mm Flavor Imprint Code RP124 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:30142-324-30 1 in 1 CARTON 03/31/2020 1 30 in 1 BOTTLE; 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 03/31/2020 Labeler - KROGER COMPANY (006999528)