Label: REGULAR STRENGTH STOMACH RELIEF- bismuth subsalicylate tablet, chewable

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

Drug Label Information

Updated February 10, 2025

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  • Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)
    Bismuth subsalicylate 262 mg

  • PURPOSE

    Purpose
    Upset stomach reliever and antidiarrheal

  • INDICATIONS & USAGE

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

  • WARNINGS

    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)
    • 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 or last more than 2 days
    • 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 (1-800-222-1222).

  • DOSAGE & ADMINISTRATION

    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: ask a doctor
    drink plenty of clear fluids to help prevent dehydration caused by diarrhea

  • OTHER SAFETY INFORMATION

    Other information

    • each tablet contains: calcium 140 mg
    • salicylate 101 mg
    • low sodium
    • avoid excessive heat (over 104°F or 40°C)
  • INACTIVE INGREDIENT

    Inactive ingredients calcium carbonate, D&C red #27 lake, flavor, magnesium stearate, mannitol, povidone, saccharin sodium, talc

  • QUESTIONS

    Questions or comments?

    call 1-877-290-4008

  • PRINCIPAL DISPLAY PANEL

    727R-DG-Bismuth-30s-ifc

  • INGREDIENTS AND APPEARANCE
    REGULAR STRENGTH STOMACH RELIEF 
    bismuth subsalicylate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-204
    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
    MANNITOL (UNII: 3OWL53L36A)  
    D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    POVIDONE (UNII: FZ989GH94E)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    TALC (UNII: 7SEV7J4R1U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    Colorpink (Light pink to pink) Scoreno score
    ShapeROUNDSize15mm
    FlavorImprint Code 118
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-204-305 in 1 CARTON09/18/2023
    16 in 1 CELLO PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00809/18/2023
    Labeler - DOLGENCORP, INC. (068331990)
    Registrant - TIME CAP LABORATORIES, INC. (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    Marksans Pharma Ltd925822975manufacture(55910-204)
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