Label: BISMUTH SUBSALICYLATE- sunmark stomach relief tablet, chewable

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

Drug Label Information

Updated June 10, 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

  • 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
    • 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

    PDP

  • INGREDIENTS AND APPEARANCE
    BISMUTH SUBSALICYLATE 
    sunmark stomach relief tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68071-4523(NDC:49348-953)
    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
    ShapeROUNDSize17mm
    FlavorImprint Code GDC122
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68071-4523-330 in 1 BOX; Type 0: Not a Combination Product08/10/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02203/01/2011
    Labeler - NuCare Pharmaceuticals,Inc. (010632300)
    Establishment
    NameAddressID/FEIBusiness Operations
    NuCare Pharmaceuticals,Inc.010632300relabel(68071-4523)
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