Label: REXALL BISMUTH- bismuth subsalicylate liquid 

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 05/14

If you are a consumer or patient please visit this version.

  • Active ingredient (in each 30 mL dose cup)

    Bismuth subsalicylate 1050 mg

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  • Purposes

    Upset stomach reliever and antidiarrheal

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  • Uses

    relieves

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

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  • Directions

    shake well before use
    use dose cup
    adults and children 12 years and over: 1 dose (30 mL or 2 TBSP) every hour as needed
    do not exceed 4 doses (120 mL or 8 TBSP) 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
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  • Other information

    each 30 mL dose cup contains: magnesium 15 mg, potassium 5 mg and sodium 12 mg
    salicylate 461 mg
    low sodium
    store at 20-25°C (68-77°F)
    protect from freezing
    does not meet USP requirements for pH
    for health information visit www.more-info.info
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  • Inactive ingredients

    D&C red #22, D&C red #28, magnesium aluminum silicate, methyl salicylate, methylcellulose, purified water, saccharin sodium, salicylic acid, sodium salicylate, sorbic acid, xanthan gum

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  • Principal Display Panel

    MAXIMUM STRENGTH

    Bismuth

    Bismuth subsalicylate 1050 mg per 30 mL

    Upset stomach reliever / Antidiarrheal

    Soothing relief for:

    Indigestion

    Upset stomach

    Diarrhea

    Heartburn

    Nausea

    GLUTEN FREE

    12 FL OZ (355 mL)

    Rexall Bismuth Image
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  • INGREDIENTS AND APPEARANCE
    REXALL BISMUTH 
    bismuth subsalicylate liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55910-337
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BISMUTH SUBSALICYLATE (SALICYLIC ACID and BISMUTH CATION) BISMUTH SUBSALICYLATE 1050 mg  in 30 mL
    Inactive Ingredients
    Ingredient Name Strength
    MAGNESIUM ALUMINUM SILICATE  
    WATER  
    SACCHARIN SODIUM  
    SALICYLIC ACID  
    SODIUM SALICYLATE  
    SORBIC ACID  
    XANTHAN GUM  
    D&C RED NO. 22  
    D&C RED NO. 28  
    METHYL SALICYLATE  
    Product Characteristics
    Color PINK (viscous) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55910-337-40 355 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part335 09/06/2012
    Labeler - Dolgencorp, LLC (068331990)
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