OTC Medication Information: Kaopectate Regular Strength Vanilla Flavor Anti Diarrheal

KAOPECTATE REGULAR STRENGTH VANILLA FLAVOR ANTI DIARRHEAL — bismuth subsalicylate liquid
Physicians Total Care, Inc.

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.

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 Sy ndrome:

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 I ngredients

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
(click image for full-size original)

KAOPECTATE REGULAR STRENGTH VANILLA FLAVOR ANTI DIARRHEAL bismuth subsalicylate liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:54868-2298(NDC:41167-4000)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BISMUTH SUBSALICYLATE (BISMUTH SUBSALICYLATE) BISMUTH SUBSALICYLATE 262 mg in 15 mL
Inactive Ingredients
Ingredient Name Strength
CARAMEL
CARBOXYMETHYLCELLULOSE SODIUM
CELLULOSE, MICROCRYSTALLINE
SODIUM SALICYLATE
SORBIC ACID
SUCROSE
WATER
XANTHAN GUM
Product Characteristics
Color Score
Shape Size
Flavor VANILLA Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-2298-1 236 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part335 05/12/2008
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel

Revised: 01/2012 Physicians Total Care, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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