Label: CVS HEALTH ANTI-DIARRHEAL VANILLA- bismuth subsalicylate suspension

  • 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 September 13, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient (in each 15 ml)

    Bismuth Subsalicylate 262 mg

  • Purposes

    Antidiarrheal/Upset stomach reliever

  • Uses

    relieves

    ▪
    traveler’s diarrhea
    ▪
    diarrhea
    ▪
    upset stomach due to overindulgence in food and drink
    ▪
    heartburn
    ▪
    indigestion
    ▪
    nausea
    ▪
    gas
  • 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

    ▪
    a sodium-restricted diet
    ▪
    fever
    ▪
    mucus in the stool

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

    ▪
    diabetes
    ▪
    gout
    ▪
    arthritis
    ▪
    anticoagulation (thinning the blood)

    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 at 1-800-222-1222.

  • Directions

    •
    shake well immediately before each use
    •
    adults and children 12 years of age and older: 30 ml or 2 tablespoonful
    •
    for accurate dosing, use convenient pre-measured dose cup
    •
    repeat dose every 1/2 hour to 1 hour as needed
    •
    do not exceed 8 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 15mL tablespoon contains: sodium 10 mg
    •
    each 15mL tablespoon contains: salicylate 130 mg
    •
    do not use if printed inner seal is broken or missing
    •
    store at room temperature
  • Inactive ingredients

    caramel, carboxymethylcellulose sodium, microcrystalline cellulose, natural and artificial flavor, potassium sorbate, salicylic acid , simethicone emulsion, sucralose, sucrose, water, xanthan gum

    Questions or comments?

    1-866-467-2748

  • PRINCIPAL DISPLAY PANEL - 355 mL Bottle Label

    50% MORE FREE THAN THE 8 OZ NATIONAL BRAND

    CVS Health ™

    NDC 59779-883-12

    Compare to the active ingredient in Kaopectate®*

    Vanilla

    Anti-Diarrheal

    Bismuth Subsalicylate, 262 mg

    Upset stomach reliever

    •
    Effective diarrhea relief
    •
    Restores natural balance
    •
    Contains Salicylates
    NaN
    Vanilla

    12 FL OZ (355 mL)

    Distributed by: CVS Pharmacy, Inc.

    One CVS Drive, Woonsocket, RI 02895

    © 2017CVS/pharmacy

    CVS.com® 1-800-SHOP CVS

    V-16415

    *This product is not manufactured or distributed by Chattem Inc., the distributor of Kaopectate ®.

    CVS Health Anti-Diarrheal
  • INGREDIENTS AND APPEARANCE
    CVS HEALTH ANTI-DIARRHEAL VANILLA 
    bismuth subsalicylate suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-883
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Bismuth subsalicylate (UNII: 62TEY51RR1) (Salicylic acid - UNII:O414PZ4LPZ, Bismuth cation - UNII:ZS9CD1I8YE) Bismuth subsalicylate262 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARAMEL (UNII: T9D99G2B1R)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    salicylic acid (UNII: O414PZ4LPZ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorVANILLAImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-883-12355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/11/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33508/11/2015
    Labeler - CVS Pharmacy,Inc. (062312574)
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