Label: PINK-BISMUTH- bismuth subsalicylate liquid

  • NDC Code(s): 53041-527-03, 53041-527-04, 53041-527-05, 53041-527-06
  • Packager: Guardian Drug Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 18, 2024

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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

    Reye's syndrome: 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.

    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 are taking 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.

  • SPL UNCLASSIFIED SECTION

  • 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 104oF or 40oC)
    • 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.

  • Principal Display Panel

    compare to the active ingredient in pepto-bismol®

    Pink-Bismuth

    Regular Strength

    Protective coating

    Bismuth subsalicylate

    Anti-diarrheal/Upset stomach reliever

    Soothing Relief For:

    upset stomach

    Indigestion

    Nausea

    Heartburn

    Diarrhea

    16 FL OZ (473 mL)

    Bismuth label

  • INGREDIENTS AND APPEARANCE
    PINK-BISMUTH  
    bismuth subsalicylate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53041-527
    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:53041-527-06473 mL in 1 BOTTLE; Type 0: Not a Combination Product05/30/2008
    2NDC:53041-527-05354 mL in 1 BOTTLE; Type 0: Not a Combination Product05/30/2008
    3NDC:53041-527-04236 mL in 1 BOTTLE; Type 0: Not a Combination Product05/30/2008
    4NDC:53041-527-03118 mL in 1 BOTTLE; Type 0: Not a Combination Product05/30/2008
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00805/30/2008
    Labeler - Guardian Drug Company (119210276)
    Registrant - Guardian Drug Company (119210276)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guardian Drug Company119210276manufacture(53041-527)
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