Label: STOMACH RELIEF- bismuth subsalicylate tablet

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

Drug Label Information

Updated June 16, 2021

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  • Active ingredient(s)

    Bismuth subsalicylate 262mg (each tablet contains 102mg salicylate)

  • Purpose

    Antidiarrheal/Antacid

  • Use(s)

    • relieves
    • travelers’ diarrhea
    • diarrhea  
    • upset stomach due to overindulgence in food and drink including:  
    • heartburn
    • indigestion
    • nausea
    • gas
    • belching
    • fullness
  • 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

    • an ulcer
    • a bleeding problem
    • bloody or black stool

    Ask a doctor before use if

    • 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

    Pregnancy/Breastfeeding

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children

    In case of accidental overdose, get medical help or contact a Poison Control Center
    (1-800-222-1222) right away.

  • Directions

    Chew or dissolve in mouth

    Adults and children 12 years and over:

    • 2 tablets (1 dose) every ½ hour or 4 tablets (2 doses) every
      hour as needed for diarrhea 
    • 2 tablets (1 dose) every ½ hour as needed for overindulgence (upset
      stomach, heartburn, indigestion, nausea)
    • do not exceed 8 doses (16 tablets) in 24 hours
    • use until diarrhea stops but not more than 2 days

    Children under 12 years of age: ask a doctor

    • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • Other information

    Phenylketonurics: contains phenylalanine 1.1mg per tablet Calcium content per tablet: 73mg

    Do not use if cellophane unit is torn

  • Storage

    Store at room temperature 15°– 30°C (59°– 86°F)

  • Inactive ingredients

    acacia gum, aspartame, calcium carbonate, D&C red #27 aluminum
    lake, dextrates, magnesium stearate, maltodextrin, microcrystalline cellulose, peppermint flavor, silicon dioxide

  • Principal Display Panel

    Stomach Relief

    Stomach Relief


  • INGREDIENTS AND APPEARANCE
    STOMACH RELIEF 
    bismuth subsalicylate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-622
    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
    ASPARTAME (UNII: Z0H242BBR1)  
    ACACIA (UNII: 5C5403N26O)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    DEXTRATES (UNII: G263MI44RU)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeROUNDSize17mm
    FlavorImprint Code RH046
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-622-3030 in 1 CELLO PACK; Type 0: Not a Combination Product06/16/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00812/23/2014
    Labeler - CDMA- QC (011920774)
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