Label: REXALL BISMUTH- 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 June 14, 2016

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  • Active ingredient (in each tablet)

    Bismuth subsalicylate 262 mg

  • Purposes

    Upset stomach reliever and 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

    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 in mouth
    •
    adults and children 12 years and over: 2 tablets every ½ to 1 hour as needed
    •
    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 information

    •
    each tablet contains: calcium 190 mg
    •
    salicylate 104 mg
    •
    very low sodium
    •
    store at 20-25°C (68-77°F). Avoid excessive heat over 104°F (40°C).
  • Inactive Ingredients

    calcium carbonate, D&C red #27 aluminum lake, flavor, magnesium stearate, mannitol, saccharin sodium, stearic acid

  • Principal Display Panel

    Bismuth Tabs

    Bismuth subsalicylate 262 mg

    Upset stomach reliever / Antidiarrheal

    Soothing relief for:

    Indigestion

    Upset stomach

    Diarrhea

    Heartburn

    Nausea

    actual size

    30 Chewable Tablets

    Rexall Bismuth Tabs Image
  • INGREDIENTS AND APPEARANCE
    REXALL BISMUTH 
    bismuth subsalicylate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-469
    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)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeROUNDSize17mm
    FlavorImprint Code L469
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-469-6515 in 1 CARTON09/28/2012
    12 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33509/28/2012
    Labeler - Dolgencorp Inc (068331990)
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