Label: PINK BISMUTH- 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 October 25, 2016

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  • Active ingredient (in each 15 mL)

    Bismuth subsalicylate 262 mg

  • Purposes

    Upset stomach reliever/antidiarrheal

  • Uses

    • relieves upset stomach, heartburn, indigestion, 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 vomitting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrom, a rare but serious illness.

    Allergy alert:Contains salicylates. Do not take if you are

    • taking other salicylate products
    • allergic to salicylates (including aspirin) 

    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, a sodium-restricted diet, a magnesium restricted diet

    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 this and all drugs out of the reach of children.

    In case of accidental overdose, seek professional assistance or contact a Poison Control Center right away.

  • Directions

    • Shake well before use
    • Use pre-measured cup for accurate dosing. mL = mililiter
    • Adults and children 12 years and over: 1 dose (30 mL) every 1/2 to 1 hour as needed
    • Do not take more than 4 doses 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 15 mL contains: Sodium 24 mg, Sugar free, Magnesium 32 mg
    • Salicylate 159 mg
    • Keep tightly closed
    • Avoid excessive heat (over 104°F or 40°C)
    • protect from freezing
    • store at room temperature
    • TEMPER EVIDENT: DO NOT USE THIS PRODUCT IF PRINTED INNER CAP SEAL IS BROKEN OR MISSING
  • Inactive ingredients

    carboxymethylcellulose sodium, D&C red #3, FD&C red #40, flavor, glycerin, magnesium aluminum silicate, saccharin sodium, salicylic acid, sodium benzoate, sodium salicylate, sorbitol, water

  • Questions or comments?

    1-888-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com

  • Principal Display Panel

    Compare to Original Pepto-Bismol® active ingredient

    ORIGINAL STRENGTH

    Stomach Relief

    Upset Stomach Reliever/Antidiarrheal

    Bismuth Subsalicylate 262 mg

    Protective Coating Action

    Soothing Relief for 5 Symptoms:

    Heartburn

    Indigestion

    Upset Stomach

    Nausea

    Diarrhea

    Pink Bismuth

  • INGREDIENTS AND APPEARANCE
    PINK BISMUTH 
    bismuth subsalicylate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70005-047
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE, SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE262 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    SODIUM SALICYLATE (UNII: WIQ1H85SYP)  
    SORBITOL (UNII: 506T60A25R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Product Characteristics
    ColorPINK (viscous) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70005-047-01120 mL in 1 BOTTLE; Type 0: Not a Combination Product10/25/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33510/25/2016
    Labeler - We Care Distributor Inc. (079832998)
    Establishment
    NameAddressID/FEIBusiness Operations
    PURINE PHARMA LLC019950491manufacture(70005-047)
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