KAOPECTATE (BISMUTH SUBSALICYLATE) TABLET [CHATTEM, INC.]

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KAOPECTATE (BISMUTH SUBSALICYLATE) TABLET [CHATTEM, INC.]
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NDC 41167-4002-5, 41167-4002-8
Set ID 9d15ff85-9a7c-42fe-bd85-bcbf7711c277
Category HUMAN OTC DRUG LABEL
Packager Chattem, Inc.
Generic Name
Product Class
Product Number
Application Number PART335
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  • SPL UNCLASSIFIED SECTION

    Kaopectate

  • Active ingredient (per caplet)

    Bismuth subsalicylate 262 mg

  • Purpose

    Anti-diarrheal, Upset stomach reliever

  • Uses

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

    • 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 out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • adults and children 12 years of age and older: 2 caplets
    • swallow caplets with water; do not chew
    • repeat does 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 caplet contains: total salicylates 99 mg
    • do not use if carton was opened or if printed foil inner seal under bottle cap is torn or missing
    • store at room temperature 20º-25ºC (68º-77º F)
  • Inactive Ingredients

    croscarmellose sodium, crospovidone, hydrated silica, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, pharmaceutical ink, povidone, sodium lauryl sulfate, stearic acid, talc, titanium dioxide, triacetin (309-034)

    Distributed by:
    Chattem, Inc.
    P.O. Box 2219
    Chattanooga, TN
    37409-0219
    USA © 2013

      

  • Principal Display Panel

    Bismuth Subsalicylate

    Kaopectate®

    • Multi-Symptom Relief
    • Anti-Diarrheal
    • Upset Stomach Reliever

    Relieves 7 types of Stomach Ailments:

    • Diarrhea
    • Upset Stomach
    • Nausea
    • Gas
    • Heartburn
    • Travelers" Diarrhea
    • Indgestion

    28 Coated Caplets

    Principal Display Panel Bismuth Subsalicylate Kaopectate® · Multi-Symptom Relief · Anti-Diarrheal · Upset Stomach Reliever Relieves 7 types of Stomach Ailments: · Diarrhea · Upset Stomach · Nausea · Gas · Heartburn · Travelers" Diarrhea · Indgestion 28 Coated Caplets

  • INGREDIENTS AND APPEARANCE
    KAOPECTATE 
    bismuth subsalicylate tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-4002
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBSALICYLATE262 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeOVAL (caplet) Size17mm
    FlavorImprint Code Kaopectate
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-4002-51 in 1 CARTON04/01/2013
    128 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33504/01/2013
    Labeler - Chattem, Inc. (003336013)
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