Label: KAOPECTATE- bismuth subsalicylate tablet, chewable

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 12, 2023

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  • ACTIVE INGREDIENT

    Active ingredient (per chew)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 chews (1 dose)
    • 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 soft chew 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-25º C (68º-77º F)
  • Inactive ingredients

    calcium carbonate, confectioner’s sugar, corn syrup, corn syrup solids, FD&C red #40 aluminum lake, glycerin, hydrogenated coconut oil, natural masking flavor, soy lecithin, strawberry flavor, sucrose, water

      

  • PRINCIPAL DISPLAY PANEL

    GREAT TASTE!

    FAST & EFFECTIVE RELIEF
    Kaopectate    ®
    Bismuth Subsalicylate • Anti-Diarrheal • Upset Stomach Reliever

    Soft Chews

    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

    24 Soft Chews
    Individually wrapped

    Strawberry Flavor

    Front Label

    FAST & EFFECTIVE RELIEF

    Do not take maximum dose for more than 2 days per week.

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

    502851

    Back Label
  • INGREDIENTS AND APPEARANCE
    KAOPECTATE 
    bismuth subsalicylate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55505-206
    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
    Calcium Carbonate (UNII: H0G9379FGK)  
    Sucrose (UNII: C151H8M554)  
    Corn Syrup (UNII: 9G5L16BK6N)  
    Fd&C Red No. 40 (UNII: WZB9127XOA)  
    Glycerin (UNII: PDC6A3C0OX)  
    Hydrogenated Coconut Oil (UNII: JY81OXM1OM)  
    Lecithin, Soybean (UNII: 1DI56QDM62)  
    Water (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeRECTANGLESize23mm
    FlavorSTRAWBERRYImprint Code K
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55505-206-691 in 1 CARTON02/01/2021
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00802/01/2021
    Labeler - Kramer Laboratories (122720675)
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