Label: KAOPECTATE- bismuth subsalicylate tablet, chewable

  • 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 29, 2021

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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

    NEW!
    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 Image

    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

    Rear Label Image
  • 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 FINALpart33502/01/2021
    Labeler - Kramer Laboratories (122720675)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bestco, LLC002149136manufacture(55505-206)
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