Label: BISMUTH CHEWABLE- bismuth subsalicylate 262 mg tablet, chewable
- NDC Code(s): 68998-046-88
- Packager: Marc Glassman, 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.
Updated December 19, 2016
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- Active ingredient
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)
Stop use and ask a doctor if
■ symptoms get worse
■ ringing in the ears or loss of hearing occurs
■ diarrhea lasts for more than 2 days
■ 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
INGREDIENTS AND APPEARANCE
bismuth subsalicylate 262 mg tablet, chewable
Product 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 final part335 04/28/2003 Labeler - Marc Glassman, Inc. (094487477)