Label: KAOPECTATE- bismuth subsalicylate tablet, coated

  • NDC Code(s): 55505-197-07, 55505-197-70
  • Packager: Kramer Laboratories
  • 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 28, 2021

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  • ACTIVE INGREDIENT

    Active ingredient (per caplet)Purposes
    Bismuth subsalicylate 262 mgAnti-diarrheal, Upset stomach reliever
  • INDICATIONS & USAGE

    Uses relieves:

    • traveler’s diarrhea
    • diarrhea
    • upset stomach due to overindulgence in food and drink, including:
      • heartburn
      • indigestion
      • nausea
      • gas
      • belching
      • fullness


  • 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 (1 dose)
    • swallow caplets with water; do not chew
    • 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 caplet contains very low sodium
    • 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-25º C (68º-77º F)
  • Inactive ingredients

    croscarmellose sodium, crospovidone, hydrated silica, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, povidone, sodium lauryl sulfate, stearic acid, talc, titanium dioxide, triacetin

      

  • Principal Display Panel

    FAST & EFFECTIVE RELIEF
    Kaopectate    ®
    Bismuth Subsalicylate

    • Anti-Diarrheal • Upset Stomach Reliver

    Diarrhea & 
    Upset Stomach

    ✓ Begins controlling symptoms from the first dose
    ✓ Quickly relieves urgency, gas, and cramping
    ✓ Effective on diarrhea from bacteria, viruses, and other causes

    CLINICALLY PROVEN MEDICINE

    28 Coated Caplets

    Front Label Image

    LOT

    EXP

    Do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken.

    Kramer Laboratories, Inc.
    Bridgewater, NJ 08807
    1-800-824-4894

    14711-07-20_K0720

    Rear Label Image

    Kaopectate®
    Bismuth Subsalicylate

    • Anti-Diarrheal
    • Upset Stomach Reliever

    Diarrhea &  Upset Stomach

    28 Coated Caplets

    Do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken.

    KEEP CARTON AS IT CONTAINS IMPORTANT INFORMATION

    Kramer Laboratories, Inc.
    Bridgewater, NJ 08807
    1-800-824-4894

    14712-07-20_K0720

    Bottle
  • INGREDIENTS AND APPEARANCE
    KAOPECTATE 
    bismuth subsalicylate tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55505-197
    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)  
    Hypromellose, Unspecified (UNII: 3NXW29V3WO)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Microcrystalline Cellulose (UNII: OP1R32D61U)  
    Mineral Oil (UNII: T5L8T28FGP)  
    Povidone, Unspecified (UNII: FZ989GH94E)  
    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 K
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55505-197-071 in 1 CARTON10/01/2020
    128 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:55505-197-701 in 1 CARTON02/01/2021
    242 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33510/01/2020
    Labeler - Kramer Laboratories (122720675)
    Establishment
    NameAddressID/FEIBusiness Operations
    Contract Pharmacal Corporation057795122manufacture(55505-197)
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