Label: PINK BISMUTH- bismuth subsalicylate liquid

  • Category: HUMAN OTC DRUG LABEL

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 August 29, 2011

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  • Active ingredient (in each 15 ml Tablespoon)

    Bismuth subsalicylate 262 mg

  • Purpose

    Upset stomach reliever and antidiarrheal

  • Uses

    relieves

    • heartburn
    • indigestion
    • upset stomach
    • nausea
    • diarrhea
  • 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 Reyes 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.

  • Directions

    • shake well before use
    • for accurate dosing, use dose cup
    • adults and children 12 years and over: 1 dose (2Tbsp 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 Tspb contains: sodium 9 mg
    • salicylate 130 mg
    • protect from freezing
    • low sodium
    • avoid excessive heat (over 104°F or 40°C)
    • sugar free
    • TAMPER EVIDENT: Do not use if printed shrinkband is missing or broken.
  • Inactive ingredients

    propylene glycol, sodium benzoate, flavor, magnesium aluminum silicate, methylcellulose, red 40, saccharin sodium, salicylic acid, sodium slicylate, sorbic acid, water, sucrose, xanthan gum

  • Package label

    Pink Bismuthimage of bottle label

  • INGREDIENTS AND APPEARANCE
    PINK BISMUTH 
    bismuth subsalicylate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0505
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH SUBSALICYLATE - UNII:62TEY51RR1) BISMUTH SUBSALICYLATE262 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    METHYLCELLULOSE (100 CPS) (UNII: 4GFU244C4J)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    SODIUM SALICYLATE (UNII: WIQ1H85SYP)  
    SORBIC ACID (UNII: X045WJ989B)  
    WATER (UNII: 059QF0KO0R)  
    SUCROSE (UNII: C151H8M554)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67510-0505-4120 mL in 1 BOTTLE
    2NDC:67510-0505-6177 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33508/29/2011
    Labeler - Kareway Product, Inc. (121840057)
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