Label: KAOPECTATE VANILLA FLAVOR ANTI DIARRHEAL- bismuth subsalicylate liquid

  • NDC Code(s): 55505-198-36, 55505-198-64
  • Packager: Kramer Laboratories
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 15, 2023

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  • ACTIVE INGREDIENT

    Active ingredient (per 15 mL)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

    • a sodium-restricted diet
    • fever
    • mucus in the stool

    Ask a doctor or pharmacist before use if you are taking any drug for

    • diabetes
    • gout
    • arthritis
    • anticoagulation (thinning the blood)

    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

    • shake well immediately before each use
    • only use pre-measured dose cup
    • adults and children 12 years of age and older:
      • 1 dose (30 mL) every 1/2 hour to 1 hour as needed.
      • do not exceed 8 doses (240 mL) 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 15 mL dose cup contains: sodium 6 mg and salicylate 135mg
    • store at room temperature 20º-25º C (68º-77º F)
  • Inactive Ingredients

    carboxymethylcellulose sodium, flavor, microcrystalline cellulose, purified water, sodium salicylate, sorbic acid, sucrose, xanthan gum

  • Principal Display Panel

    NEW IMPROVED TASTE!

    Kaopectate    ®
    Bismuth Subsalicylate 262 mg
    • 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

    11 fl oz (325mL)

    Vanilla Flavor

    68OVAN11KA0LF

    Front Label

    Kaopectate® Vanilla 11oz

    Do not use if inner seal is broken
    or missing

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

    Lot:


    Exp:

    PEEL CORNER TO READ COMPLETE
    DRUG FACTS AND INFORMATION

    680VAN11KA0LB

    Back Label

        

      

  • INGREDIENTS AND APPEARANCE
    KAOPECTATE VANILLA FLAVOR ANTI DIARRHEAL 
    bismuth subsalicylate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55505-198
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Bismuth Subsalicylate (UNII: 62TEY51RR1) (Bismuth Cation - UNII:ZS9CD1I8YE) Bismuth Subsalicylate262 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    Carboxymethylcellulose Sodium, Unspecified (UNII: K679OBS311)  
    Microcrystalline Cellulose (UNII: OP1R32D61U)  
    Sodium Salicylate (UNII: WIQ1H85SYP)  
    Sorbic Acid (UNII: X045WJ989B)  
    Sucrose (UNII: C151H8M554)  
    Water (UNII: 059QF0KO0R)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorVANILLAImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55505-198-36236 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2020
    2NDC:55505-198-64325 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00810/01/2020
    Labeler - Kramer Laboratories (122720675)
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