Label: BISMATROL- bismuth subsalicylate tablet, chewable
- NDC Code(s): 63187-650-30
- Packager: Proficient Rx LP
- This is a repackaged label.
- Source NDC Code(s): 0904-1315
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 1, 2024
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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
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 or dissolve in mouth
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- adults and children 12 years and over: 2 tablets every 1/2 to 1 hour as needed
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- do not take more than 8 doses (16 tablets) in 24 hours
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- children under 12 years: ask a doctor
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- drink plenty of fluids to help prevent dehydration which may accompany diarrhea.
Other information: each tablet contains:
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- sodium less than 1 mg
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- salicylate 102 mg
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- calcium 140 mg
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- very low sodium
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- avoid excessive heat (over 104˚F or 40˚C)
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- TAMPER EVIDENT: Do not use if individual compartments are torn or missing.
- Inactive ingredients
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
BISMATROL
bismuth subsalicylate tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63187-650(NDC:0904-1315) 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 CALCIUM CARBONATE (UNII: H0G9379FGK) D&C RED NO. 27 (UNII: 2LRS185U6K) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) STARCH, CORN (UNII: O8232NY3SJ) SACCHARIN SODIUM (UNII: SB8ZUX40TY) Product Characteristics Color pink Score no score Shape ROUND Size 17mm Flavor Imprint Code GDC122 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63187-650-30 5 in 1 CARTON 12/01/2018 1 6 in 1 BLISTER 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 01/03/2003 Labeler - Proficient Rx LP (079196022) Establishment Name Address ID/FEI Business Operations Proficient Rx LP 079196022 RELABEL(63187-650)
