Label: CHEWABLE- bismuth subsalicylate tablet, chewable
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Contains inactivated NDC Code(s)
NDC Code(s): 56062-469-65 - Packager: Publix Super Markets 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.
Drug Label Information
Updated November 26, 2011
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- 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
- allergic to salicylates (including aspirin)
- taking other salicylate products
Ask a doctor before use if you have
- fever
- mucus in the stool
- kidney stones
- a calcium-restricted diet
Ask a doctor or pharmacist before use if you are
taking any drug for
- anticoagulation (thinning the blood)
- diabetes
- gout
- arthritis
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Directions
- chew or dissolve tablets in mouth
- drink plenty of clear fluids to help prevent dehydration 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 not more than 2 days
- children under 12 years: ask a doctor
- Other information
- Inactive ingredients
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
CHEWABLE
bismuth subsalicylate tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:56062-469 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH SUBSALICYLATE - UNII:62TEY51RR1) BISMUTH SUBSALICYLATE 262 mg Inactive Ingredients Ingredient Name Strength CALCIUM CARBONATE (UNII: H0G9379FGK) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) SACCHARIN SODIUM (UNII: SB8ZUX40TY) Product Characteristics Color PINK Score no score Shape ROUND Size 17mm Flavor Imprint Code L469 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:56062-469-65 5 in 1 CARTON 1 6 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part335 03/15/2001 Labeler - Publix Super Markets Inc (006922009)