Label: BISMATROL- bismuth subsalicylate liquid

  • 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 January 13, 2021

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  • Active ingredient (in each 15 mL tbsp)

    Bismuth subsalicylate 262 mg

  • Purpose

    Upset stomach reliever and anti-diarrheal

  • KEEP OUT OF REACH OF CHILDREN


  • Uses

    relieves:

    • diarrhea
    • heartburn
    • indigestion
    • nausea
    • upset stomach associated with these symptoms
  • Warnings

    Children and teenagers who have or are recovering from children 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. Reye's syndrome:

    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

    • bloody or black stool
    • an ulcer
    • a bleeding problem

    Ask a doctor before use if you have

    • fever
    • mucus in the stool

    Ask a doctor or pharmacist before use if you aretaking any drug for

    • anticoagulation (thinning of 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  immediately.

  • Directions

    • shake well before use
    • for accurate dosing, use dose cup
    • adults and children 12 years and over: 1 dose (2 tbsp or 30 mL) every 1/2 to 1 hour as needed
    • do not exceed 8 doses (16 tbsp or 240 mL) 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 Tbsp contains: sodium 5 mg, salicylate 130 mg, potassium 15 mg
    • protect from freezing
    • avoid excessive heat (over 104 F or 40 C) oo
    • . TAMPER EVIDENT:Do not use if imprinted shrinkband is missing or broken
  • Inactive ingredients

    benzoic acid, D and C red 22, D and C red 28, flavor, hydroxy ethyl cellulose, potassium hydroxide, purified water, saccharin sodium, salicylic acid, simethicone, xanthan gum.

  • BISMATROL (BISMUTH SUBSALICYLATE) LIQUID

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  • INGREDIENTS AND APPEARANCE
    BISMATROL  
    bismuth subsalicylate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-1313(NDC:0904-1313)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBSALICYLATE262 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    D&C RED NO. 22 (UNII: 1678RKX8RT)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorpinkScore    
    ShapeSize
    FlavorWINTERGREENImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17856-1313-115 mL in 1 CUP; Type 0: Not a Combination Product01/13/2021
    2NDC:17856-1313-330 mL in 1 CUP; Type 0: Not a Combination Product01/13/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33505/30/2008
    Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)
    Establishment
    NameAddressID/FEIBusiness Operations
    ATLANTIC BIOLOGICALS CORP.047437707RELABEL(17856-1313) , REPACK(17856-1313)
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