Label: BISMUTH CHEWABLE- bismuth subsalicylate 262 mg tablet, chewable
- NDC Code(s): 68998-046-88
- Packager: Marc Glassman, Inc.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated December 19, 2016
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- Official Label (Printer Friendly)
- Active ingredient
- 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)
■ taking other salicylate products
Ask a doctor or pharmacist before use if
you are taking a drug for
■ anticoagulation (thinning of the blood)
■ diabetes
■ gout
■ arthritis
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Directions
■ drink plenty of clear fluids to help revent deydration caused by diarrhea
■ Adults and children 12 years and over: 2 tablets every ½ to 1 hour or 4 tablets every hour as needed
■ do not exceed 16 tablets in 24 hours
■ use until diarrhea stops but no more than 2 days
■ Children under 12 years of age: ask a doctor
- Other information
- Inactive ingredients
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
BISMUTH CHEWABLE
bismuth subsalicylate 262 mg tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68998-046 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 ASPARTAME (UNII: Z0H242BBR1) CALCIUM CARBONATE (UNII: H0G9379FGK) D&C RED NO. 27 (UNII: 2LRS185U6K) DEXTRATES (UNII: G263MI44RU) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color pink Score no score Shape ROUND Size 17mm Flavor PEPPERMINT Imprint Code RH;046 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68998-046-88 30 in 1 CARTON 04/28/2003 1 1 in 1 CELLO PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M008 04/28/2003 Labeler - Marc Glassman, Inc. (094487477)