Label: BISMUTH- bismuth subsalicylate tablet
- NDC Code(s): 69168-046-32, 69168-046-69, 69168-046-88
- Packager: Allegiant Health
- 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 November 7, 2018
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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 any drug for
- anticoagulation (thinning the blood)
- diabetes
- gout
- arthritis
- Keep Out of Reach of Children
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Directions
- chew or dissolve in mouth
Adults and children over 12 years : 2 tablets (1 dose) every ½ hour or 4 tablets (2 doses) every hour as needed for diarrhea
- 2 tablets (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
- do not exceed 8 doses (16 tablets) in 24 hours
- use until diarrhea stops but no more than 2 days
Children under 12 years of age: ask a doctor
- drink plenty of clear fluids to prevent dehydration caused by diarrhea
- Inactive Ingredients
- Package/Label Principal Display Panel
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INGREDIENTS AND APPEARANCE
BISMUTH
bismuth subsalicylate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69168-046 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE) 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) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ACACIA (UNII: 5C5403N26O) MALTODEXTRIN (UNII: 7CVR7L4A2D) PEPPERMINT (UNII: V95R5KMY2B) Product Characteristics Color pink Score no score Shape ROUND Size 17mm Flavor Imprint Code RH046 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69168-046-69 12 in 1 CELLO PACK; Type 0: Not a Combination Product 12/23/2014 2 NDC:69168-046-88 30 in 1 CELLO PACK; Type 0: Not a Combination Product 12/23/2014 3 NDC:69168-046-32 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/31/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part335 12/23/2014 Labeler - Allegiant Health (079501930)