KAOPECTATE REGULAR STRENGTH CHERRY FLAVOR (BISMUTH SUBSALICYLATE) LIQUID [CHATTEM, INC.]

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KAOPECTATE REGULAR STRENGTH CHERRY FLAVOR (BISMUTH SUBSALICYLATE) LIQUID [CHATTEM, INC.]
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NDC 41167-6050-2, 41167-6050-5
Set ID 8f99ffa2-f064-4c92-bf4d-d2dc54278b90
Category HUMAN OTC DRUG LABEL
Packager Chattem, Inc.
Generic Name
Product Class
Product Number
Application Number PART335
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  • SPL UNCLASSIFIED SECTION

  • Active Ingredient 

    (per 15mL):

    Bismuth subsalicylate 262 mg

  • Purpose

    Anti-diarrheal

    Upset stomach reliever

  • Uses

    • 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

    • 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.

  • 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
  • Other Information

    •  each 15 mL tablespoonful contains: potassium 5 mg, sodium 9 mg
    •  each 15 mL tablespoonful contains: total salicylates 130 mg
    •  do not use if inner seal is broken or missing
  • 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 

  • Principal Display Panel

    NDC 41167-6050-2

    Bismuth Subsalicylate

    Kaopectate®

    • Anti-Diarrheal
    • Upset Stomach Reliever

    Contains Salicylates

    Cherry

    262 mg bismuth subsalicylate per 15 mL

    8 fl oz (236 mL)

    0070902-02

       Principal Display Panel NDC 41167-6050-2 Bismuth Subsalicylate Kaopectate® • Anti-Diarrheal • Upset Stomach Reliever Contains Salicylates Cherry 262 mg bismuth subsalicylate per 15 mL 8 fl oz (236 mL) 0070902-02

    Principal Display Panel NDC 41167-6050-2 Bismuth Subsalicylate Kaopectate® • Anti-Diarrheal • Upset Stomach Reliever Contains Salicylates Cherry 262 mg bismuth subsalicylate per 15 mL 8 fl oz (236 mL) 0070902-02   

  • INGREDIENTS AND APPEARANCE
    KAOPECTATE REGULAR STRENGTH CHERRY FLAVOR 
    bismuth subsalicylate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-6050
    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
    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    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-6050-2177 mL in 1 BOTTLE; Type 0: Not a Combination Product04/30/2004
    2NDC:41167-6050-5236 mL in 1 BOTTLE; Type 0: Not a Combination Product04/30/2004
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33504/30/2004
    Labeler - Chattem, Inc. (003336013)
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