Label: STOMACH RELIEF- bismuth subsalicylate tablet

  • 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 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 finalpart33512/23/2014
    Labeler - CDMA- QC (011920774)
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