Label: CHEWABLE- 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 November 26, 2011

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  • Active ingredient (in each tablet)

    Bismuth subsalicylate 262 mg

  • Purpose

    Upset stomach reliever/antidiarrheal

  • Uses

    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

    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
    • kidney stones
    • a calcium-restricted diet

    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
    • 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)

  • Directions

    • chew or dissolve tablets in mouth
    • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
    • adults and children 12 years and over: 2 tablets every ½ to 1 hour, or 4 tablets every hour as needed
    • do not exceed 16 tablets in 24 hours
    • use until diarrhea stops but not more than 2 days
    • children under 12 years: ask a doctor
  • Other information

    • each tablet contains: calcium 265 mg and salicylate 99 mg
    • store at 20°-25°C (68°-77°F)
  • Inactive ingredients

    calcium carbonate, D&C red #27 aluminum lake, FD&C blue #1 aluminum lake, flavor, magnesium stearate, mannitol, saccharin sodium

  • Principal Display Panel

    STOMACH RELIEF

    chewable

    BISMUTH SUBSALICYLATE 262mg

    ANTIDIARRHEAL

    UPSET STOMACH RELIEVER

    Soothing relief for:

    heartburn

    indigestion

    upset stomach

    nausea

    diarrhea

    ACTUAL SIZE

    Compare to Active Ingredient in Pepto-Bismol® Chewable Tablets

    Chewable Carton Image 1

    Chewable Carton Image 1

    Chewable Carton Image 2

    Chewable Carton Image 2

  • INGREDIENTS AND APPEARANCE
    CHEWABLE 
    bismuth subsalicylate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56062-469
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH SUBSALICYLATE - UNII:62TEY51RR1) BISMUTH SUBSALICYLATE262 mg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeROUNDSize17mm
    FlavorImprint Code L469
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56062-469-655 in 1 CARTON
    16 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33503/15/2001
    Labeler - Publix Super Markets Inc (006922009)
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