Label: GNP PINK BISMUTH- bismuth subsalicylate tablet
- NDC Code(s): 24385-017-58
- Packager: Amerisource Bergen
- 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 April 6, 2016
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each caplet)
- Purpose
- KEEP OUT OF REACH OF CHILDREN
- 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
Do not use if you have
- bloody or black stool
- an ulcer
- a bleeding problem
Ask a doctor before use if you have
- fever
- mucus in the stool
Ask a doctor or pharmacist before use if you are taking any drug for
- anticoagulation (thinning of the blood)
- diabetes
- gout
- arthritis
- Directions
- Other information
- Inactive ingredients
- PDP
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INGREDIENTS AND APPEARANCE
GNP PINK BISMUTH
bismuth subsalicylate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:24385-017 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 CALCIUM CARBONATE (UNII: H0G9379FGK) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) D&C RED NO. 27 (UNII: 2LRS185U6K) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) Product Characteristics Color pink Score no score Shape capsule Size 16mm Flavor Imprint Code G172 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:24385-017-58 1 in 1 CARTON 08/08/2011 1 40 in 1 BOTTLE; 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 08/08/2011 Labeler - Amerisource Bergen (007914906) Registrant - Guardian Drug Company (119210276) Establishment Name Address ID/FEI Business Operations Guardian Drug Company 119210276 manufacture(24385-017)