Label: SUNMARK STOMACH RELIEF- bismuth subsalicylate tablet, chewable

  • NDC Code(s): 49348-953-44
  • Packager: Strategic Sourcing Services LLC
  • 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 January 7, 2022

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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
    • use untill diarrhea stops but not more than 2 days
    • children under 12 years: ask a doctor
    • drink plenty of fluids to help prevent dehydration which 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 open.
  • Inactive ingredients

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

  • Principal Display Panel

    sunmark

    COMPARE TO PEPTO-BISMOL® CHEWABLE TABLETS ACTIVE INGREDIENT*

    NDC 49348-953-44

    stomach relief tablets

    Regular Strength

    Antidiarrheal/Upset Stomach Reliever

    Soothing relief for upset stomach, nausea

    heartburn, indigestion and diarrhea

    BISMUTH SUBSALICYLATE 262 mg

    CHEWABLE

    30 TABLETS

    image description

  • INGREDIENTS AND APPEARANCE
    SUNMARK STOMACH RELIEF 
    bismuth subsalicylate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-953
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ, 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:49348-953-445 in 1 CARTON09/24/2019
    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 finalpart33509/24/2019
    Labeler - Strategic Sourcing Services LLC (116956644)
    Registrant - Guardian Drug Company (119210276)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guardian Drug Company119210276manufacture(49348-953)
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