Label: BISMATROL- bismuth subsalicylate tablet, chewable
-
Contains inactivated NDC Code(s)
NDC Code(s): 53217-058-01 - Packager: Aidarex Pharmaceuticals LLC
- This is a repackaged label.
- Source NDC Code(s): 0904-1315
- Category: HUMAN OTC DRUG LABEL
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 December 13, 2013
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- KEEP OUT OF REACH OF CHILDREN
- Uses
-
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 of the blood)
- diabetes
- gout
- arthritis
- allergic to salicylates (including aspirin)
-
Directions
- chew or dissolve in mouth
- adults and children 12 years and over: 2 tablets every 1/2 to 1 hour as needed
- do not take more than 8 doses (16 tablets) in 24 hours
- children under 12 years: ask a doctor
- drink plenty of fluids to help prevent dehydration which may accompany diarrhea.
- sodium less than 1 mg
- salicylate 102 mg
- calcium 140 mg
- very low sodium
- avoid excessive heat (over 104˚F or 40˚C)
- TAMPER EVIDENT: Do not use if individual compartments are torn or missing.
- Inactive ingredients
- Principal Display Panel
-
INGREDIENTS AND APPEARANCE
BISMATROL
bismuth subsalicylate tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53217-058(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:53217-058-01 30 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part335 01/03/2003 Labeler - Aidarex Pharmaceuticals LLC (801503249)