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

  • 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 September 16, 2023

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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
    D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    MANNITOL (UNII: 3OWL53L36A)  
    POVIDONE (UNII: FZ989GH94E)  
    TALC (UNII: 7SEV7J4R1U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    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 finalM00809/18/2023
    Labeler - DOLGENCORP, INC. (068331990)
    Registrant - TIME CAP LABORATORIES, INC. (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    Marksans Pharma Ltd925822975manufacture(55910-204)
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