Label: BISMATROL- bismuth subsalicylate tablet, chewable

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated April 6, 2023

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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

  • 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.

  • Keep Out of Reach of Children

    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 caused by diarrhea.
  • Other information:

    each tablet contains:

    •
    sodium less than 1 mg
    •
    salicylate 102 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.

  • Principal Display Panel

    MAJOR

    NDC 68788-7140-3

    Bismatrol Chewable Tablets

    Soothing, coating action provides

    fast relief for heartburn, indigestion, nausea, upset stomach and diarrhea

    COMPARE TO THE ACTIVE INGREDIENT IN PEPTO-BISMOL®

    Relabeled By: Preferred Pharmaceuticals Inc.

    30 chewable tablets

    Bismatrol Chewable Tablets
  • INGREDIENTS AND APPEARANCE
    BISMATROL 
    bismuth subsalicylate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-7140(NDC:0904-1315)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE) 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, 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:68788-7140-35 in 1 CARTON04/19/2018
    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 finalpart33504/19/2018
    Labeler - Preferred Pharmaceuticals Inc. (791119022)
    Registrant - Preferred Pharmaceuticals Inc. (791119022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Preferred Pharmaceuticals Inc.791119022RELABEL(68788-7140)
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