Label: KAOPECTATE CHERRY FLAVOR ANTI DIARRHEAL- bismuth subsalicylate liquid

  • 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 December 16, 2022

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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 ½ 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 9 mg
    •  do not use if inner seal is broken or missing
    •  store at room temperature 20º-25º C (68º-77º F)
  • Inactive Ingredients

    caramel, carboxymethylcellulose sodium, flavor, FD&C Red No. 40 microcrystalline cellulose, sodium salicylate, sorbic acid, sucrose, water, xanthan gum

  • Principal Display Panel

    Kaopectate®
    Bismuth Subsalicylate
    • Anti-Diarrheal • Upset Stomach Reliever

    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

    8 fl oz (236 mL)

    Cherry Flavor

    201H140 

    Front Label Image

    Peel

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

    LOT EXP

    P013H16000

    Rear Label Image

       

      

  • INGREDIENTS AND APPEARANCE
    KAOPECTATE CHERRY FLAVOR ANTI DIARRHEAL 
    bismuth subsalicylate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55505-201
    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
    Caramel (UNII: T9D99G2B1R)  
    Carboxymethylcellulose Sodium, Unspecified Form (UNII: K679OBS311)  
    Fd&C Red No. 40 (UNII: WZB9127XOA)  
    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
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55505-201-36236 mL in 1 BOTTLE; Type 0: Not a Combination Product11/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33511/01/2020
    Labeler - Kramer Laboratories (122720675)
    Establishment
    NameAddressID/FEIBusiness Operations
    Trillium Health Care Products Inc.255426306manufacture(55505-201)
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