Kaopectate Regular Strength Vanilla Flavor Anti Diarrheal
FDA Label NDC 54868-2298

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Physicians Total Care, Inc. for the product Kaopectate Regular Strength Vanilla Flavor Anti Diarrheal (NDC 54868-2298). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (per 15ml):, purpose, uses, reye’s syndrome:, do not take if you are, do not use if you have, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are taking any drug for, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

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.

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 (2298)

    Image Of Package Label (2298)

      

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