Label: SUNMARK STOMACH RELIEF- bismuth subsalicylate tablet, chewable

  • NDC Code(s): 70677-0138-1
  • Packager: Strategic Sourcing Services LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 13, 2024

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  • ACTIVE INGREDIENT(in each tablet)

    Bismuth subsalicylate 262 mg


  • 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 immediately 1-800-222-1222.

  • 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
    • use until diarrhea stops but not more than 2 days
    • children under 12 years: ask a doctor
    • drink plenty of 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. 
  • INACTIVE INGREDIENTS

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

  • PRINCIPAL DISPLAY PANEL

    sunmark

    NDC 70677-0138-1

    COMPARE TO PEPTO-BISMOL® CHEWABLE TABLETS ACTIVE INGREDIENT*

    stomach relief

    Regular Strength

    Antidiarrheal / Upset Stomach Reliever 
    Soothing Relief For Upset stomach, Nausea,

    Heartburn, Indigestion & Diarrhea

    BISMUTH SUBSALICYLATE 262 mg

    CHEWABLE
    30 TABLETS

    92

  • INGREDIENTS AND APPEARANCE
    SUNMARK STOMACH RELIEF 
    bismuth subsalicylate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70677-0138
    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:70677-0138-15 in 1 BOX09/08/2021
    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 DrugM00809/08/202112/13/2024
    Labeler - Strategic Sourcing Services LLC (116956644)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guardian Drug Company119210276MANUFACTURE(70677-0138)
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