Label: KAOPECTATE- bismuth subsalicylate tablet, film coated

  • 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 April 1, 2013

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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)