Label: KAOPECTATE REGULAR STRENGTH CHERRY FLAVOR- bismuth subsalicylate liquid

  • NDC Code(s): 41167-6050-2, 41167-6050-5
  • Packager: Chattem, Inc.
  • 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, 2015

If you are a consumer or patient please visit this version.

  • Active Ingredient 

    (per 15mL):

    Bismuth subsalicylate 262 mg

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  • Purpose

    Anti-diarrheal

    Upset stomach reliever

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  • Uses

    • relieves diarrhea
    • relieves nausea and upset stomach associated with this symptom
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  • 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

    • 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.

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  • Directions

    • shake well immediately before each use
    • adults and children 12 years of age and older: 30 mL or 2 tablespoonfuls
    • 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
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  • Other Information

    •  each 15 mL tablespoonful contains: sodium 4 mg
    •  each 15 mL tablespoonful contains: total salicylates 130 mg
    •  do not use if inner seal is broken or missing
    •  low sodium
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  • Inactive Ingredients

    caramel, carboxymethylcellulose sodium, flavor, microcrystalline cellulose, red 40, sodium salicylate, sorbic acid, sucrose, water, xanthan gum (245-240)

    Dist. by CHATTEM, INC.

    P.O. Box 2219

    Chattanooga, TN 37409 USA

    © 2008 Chattem, Inc.

    Made in Canada

    CHATTEM® www.chattem.com 

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  • Principal Display Panel

    NDC 41167-6050-2

    Bismuth Subsalicylate

    Kaopectate®

    • Anti-Diarrheal
    • Upset Stomach Reliever

    Goes to the Source to Help Relieve Diarrhea

    Contains Salicylates

    Cherry

    262 mg bismuth subsalicylate per 15 mL

    6 fl oz (177 mL)

    0071005-01

    Principal Display Panel   Principal Display Panel

    Principal Display Panel  Principal Display Panel

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  • INGREDIENTS AND APPEARANCE
    KAOPECTATE REGULAR STRENGTH CHERRY FLAVOR 
    bismuth subsalicylate liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-6050
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBSALICYLATE 262 mg  in 15 mL
    Inactive Ingredients
    Ingredient Name Strength
    CARAMEL (UNII: T9D99G2B1R)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SODIUM SALICYLATE (UNII: WIQ1H85SYP)  
    SORBIC ACID (UNII: X045WJ989B)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor CHERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41167-6050-2 177 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2 NDC:41167-6050-5 236 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part335 04/30/2004
    Labeler - Chattem, Inc. (003336013)
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