Label: KAOPECTATE REGULAR STRENGTH VANILLA 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 January 24, 2012

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

  • Active Ingredient (per 15mL): 

    Bismuth subsalicylate 262 mg

  • Purpose

    Anti-diarrheal

    Upset stomach reliever

  • Uses

    • relieves diarrhea
    • relieves nausea and upset stomach associated with this symptom
  • 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

    • 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
    • adults and children 12 years of age and older: 30 mL or 2 tablespoonfuls
    • for accurate dosing, use convenient pre-measured dose cup
    • 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 15 mL tablespoonful contains: sodium 4 mg
    •  each 15 mL tablespoonful contains: total salicylates 130 mg
    •  do not use if inner seal is broken or missing
    •  low sodium
  • Inactive Ingredients

    caramel, carboxymethylcellulose sodium, flavor, microcrystalline cellulose, sodium salicylate, sorbic acid, sucrose, water, xanthan gum (245-241)

    Dist. by CHATTEM, INC.

    P.O. Box 2219

    Chattanooga, TN 37409 USA

    © 2008 Chattem, Inc.

    Made in Canada

    CHATTEM® www.chattem.com



    Additional barcode labeling by:
    Physicians Total Care, Inc.
    Tulsa, Oklahoma      74146

  • Principal Display Panel


    Kaopectate®

    • Anti-Diarrheal
    • Upset Stomach Reliever

    Bismuth Subsalicylate

    Goes to the Source to Help Relieve Diarrhea

    Contains Salicylates

    Vanilla

    Regular Flavor

    262 mg bismuth subsalicylate per 15 mL

    8 fl oz (236 mL)

    NDC 54868-2298-1

    image of package label

      

  • INGREDIENTS AND APPEARANCE
    KAOPECTATE REGULAR STRENGTH VANILLA FLAVOR ANTI DIARRHEAL 
    bismuth subsalicylate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-2298(NDC:41167-4000)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH SUBSALICYLATE - UNII:62TEY51RR1) BISMUTH SUBSALICYLATE262 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARAMEL (UNII: T9D99G2B1R)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    CELLULOSE, MICROCRYSTALLINE (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:54868-2298-1236 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33505/12/2008
    Labeler - Physicians Total Care, Inc. (194123980)
    Establishment
    NameAddressID/FEIBusiness Operations
    Physicians Total Care, Inc.194123980relabel
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!