Label: KROGER DIGESTIVE RELIEF- bismuth subsalicylate tablet, film coated
- NDC Code(s): 30142-524-24
- 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)
- Drug Facts
- 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
- ▪
- allergic to salicylates (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 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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- swallow with water, do not chew
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- adults and children 12 years and older: 2 caplets every 1/2 to 1 hour as needed
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- do not exceed 8 doses (16 caplets) 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
- Questions or comments?
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PRINCIPAL DISPLAY PANEL
NDC# 30142-524-24
COMPARE TO the active ingredient PEPTO-BISMOL®
*See top panel
Kroger®
Stomach Relief
Bismuth Subsalicylate 262 mg
Upset stomach Reliever/ Antidiarrheal
5 SYMPTOMS RELIEF
- •
- Heartburn
- •
- Indigestion
- •
- Nausea
- •
- Upset Stomach
- •
- Diarrhea
24 CAPLETS
TAMPER EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS BROKEN OR MISSING.
IMPORTANT: KEEP THIS CARTON FOR FUTURE REFERENCE ON FULL LABELING
DISTRIBUTED BY:
THE KROGER CO.
CINCINNATI, OHIO 45202
QUALITY GUARANTEE
800-632-6900
www.kroger.com
*This product is not manufactured or distributed by Procter & Gamble Inc., the distributor of Pepto-Bismol®.
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INGREDIENTS AND APPEARANCE
KROGER DIGESTIVE RELIEF
bismuth subsalicylate tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:30142-524 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 CALCIUM CARBONATE (UNII: H0G9379FGK) CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK) D&C RED NO. 27 (UNII: 2LRS185U6K) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SODIUM LAURYL SULFATE (UNII: 368GB5141J) Product Characteristics Color PINK Score no score Shape OVAL (Caplet) Size 16mm Flavor Imprint Code RP125 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:30142-524-24 1 in 1 CARTON 03/31/2020 1 24 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)