Label: GNP PINK BISMUTH- bismuth subsalicylate tablet, chewable

  • 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 April 5, 2016

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  • Active ingredient (in each tablet)

    Bismuth subsalicylate 262 mg

    (total salicylate 102 mg per tablet)

  • Purpose

    Upset stomach reliever and anti-diarrheal

  • KEEP OUT OF REACH OF CHILDREN

  • uses

    • relieves:
    • diarrhea
    • heartburn
    • indigestion
    • nausea
    • upset stomach associated with these symptoms
  • 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 stools
    • 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

    When using this product

    a temporary, but harmless darkening of the stool and/or tongue may occur.

    Stop use and ask a doctor if
    • symptoms get worse
    • ringing in the ears or loss of hearing occurs
    • diarrhea lasts more than 2 days

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

  • 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.
  • Other information

    • each tablet contains: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

    calcium carbonate, D&C red 27 aluminum lake, flavor, magnesium stearate, mannitol, pregelatinized starch, saccharin sodium.

  • PDP

    Good Neighbor Pharmacy

    Compare to pepto-bismol chewable active ingredient

    protective coating

    Pink Bismuth

    Anti-Diarrheal

    Soothing relief for:

    upset stomach, indigestion, heartburn, diarrhea & neausea

    30 chewable tablets

    Carton

  • INGREDIENTS AND APPEARANCE
    GNP PINK BISMUTH 
    bismuth subsalicylate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24385-024
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE262 mg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeROUNDSize17mm
    FlavorImprint Code GDC122
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24385-024-655 in 1 CARTON07/07/2011
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33507/07/2011
    Labeler - Amerisource Bergen (007914906)
    Registrant - Guardian Drug Company (119210276)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guardian Drug Company119210276manufacture(24385-024)
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