Label: MAJOR BISMUTH SUBSALICYLATE- bismuth subsalicylate tablet, chewable

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 11, 2024

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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

  • USE(S)

    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 behaviour 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
  • WHEN USING THIS PRODUCT

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

  • STOP USE AND ASK 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 (1-800-222-1222) 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 clear fluids to help prevent dehydration caused diarrhea
  • OTHER INFORMATION

    •
    each tablet contains:
    •
    sodium less than 1 mg
    •
    salicylate 102 mg
    •
    very low sodium
    •
    avoid excessive heat (over 104oF or 40oC)
    •
    TAMPER EVIDENT: Do not use if individual compartments are torn on open. 

    Preferred Pharmaceuticals Inc.

  • INACTIVE INGREDIENTS

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

  • PRINCIPAL DISPLAY PANEL

    MAJOR

    NDC 68788-8239-3
    *Compare to the active ingredient in Pepto-Bismol®

    Bismuth Subsalicylate 262 mg

    Upset Stomach Reliever / Anti-diarrheal

    Soothing, coating action provides fast relief for

    heartburn, indigestion

    nausea, upset stomach

    and diarrhea



    Relabeled By: Preferred Pharmaceuticals Inc.

    30 Chewable Tablets

    Schematic, timeline Description automatically generated with medium confidence
  • INGREDIENTS AND APPEARANCE
    MAJOR BISMUTH SUBSALICYLATE 
    bismuth subsalicylate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-8239(NDC:0904-7205)
    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, CORN (UNII: O8232NY3SJ)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeROUNDSize16mm
    FlavorImprint Code G122
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68788-8239-35 in 1 BOX04/06/2023
    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 Drug33504/06/2023
    Labeler - Preferred Pharmaceuticals Inc. (791119022)
    Registrant - Preferred Pharmaceuticals Inc. (791119022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Preferred Pharmaceuticals Inc.791119022RELABEL(68788-8239)
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