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 30, 2022

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  • Active ingredient (in each caplet)

    Bismuth subsalicylate 262 mg 

  • Purpose

    Upset stomach reliever/antidiarrheal 

  • Uses

    relieves:

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

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

    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 the blood)
    • gout
    • diabetes
    • 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 right away.

  • Directions

    • do not take more than directed
    • swallow with water; do not chew
    • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
    • adults and children 12 years and over: 2 caplets every ½ to 1 hour as needed. Do not exceed 8 doses (16 caplets) in 24 hours.
    • do not use for more than 2 days unless directed by a doctor
    • use until diarrhea stops, but not more than 2 days
    • children under 12 years: ask a doctor
  • Other information

    • each caplet contains: calcium 20 mg, salicylate 103 mg
    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • avoid excessive heat
    • see end flap for expiration date and lot number 
  • Inactive ingredients

    calcium carbonate, corn starch, D&C red #27 aluminum lake, D&C red #30 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, povidone, silicon dioxide, sodium starch glycolate, stearic acid

  • Questions or comments?

    1-800-426-9391

  • Principal display panel

    Compare to Pepto-Bismol® active ingredient*

    NDC 37808-346-08

    H-E-B®

    Stomach
    Relief

    Bismuth subsalicylate 262 mg
    Upset Stomach Reliever/Antidiarrheal

    Relief of:
    • Heartburn
    • Upset Stomach
    • Indigestion
    • Nausea
    • Diarrhea

    Multi-Symptom Relief

    24 CAPLETS

    actual
    size

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY
    SEAL UNDER CAP IS BROKEN OR MISSING

    *This product is not manufactured or distributed
    by The Procter & Gamble Company, owner of the
    registered trademark Pepto-Bismol®.
    50844 REV0521B34608

    MADE WITH PRIDE AND CARE FOR
    H-E-B®, SAN ANTONIO, TX 78204

    H-E-B®
    100%
    GUARANTEE
    promise

    If you aren't completely
    pleased with this
    product, we'll be happy 
    to replace it or
    refund your money.
    You have our word on it.

    HEB 44-346

    HEB 44-346

  • INGREDIENTS AND APPEARANCE
    STOMACH RELIEF 
    bismuth subsalicylate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-346
    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)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeOVALSize16mm
    FlavorImprint Code 44;346
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37808-346-081 in 1 CARTON05/06/2011
    124 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33505/06/2011
    Labeler - H E B (007924756)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(37808-346)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837manufacture(37808-346)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.117025878manufacture(37808-346)
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