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NDC 41167-4000-02 Kaopectate Regular Strength Vanilla Flavor Anti Diarrheal 262 mg/15mL Details

Kaopectate Regular Strength Vanilla Flavor Anti Diarrheal 262 mg/15mL

Kaopectate Regular Strength Vanilla Flavor Anti Diarrheal is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Chattem, Inc.. The primary component is BISMUTH SUBSALICYLATE.

MedlinePlus Drug Summary

Bismuth subsalicylate is used to treat diarrhea, heartburn, and upset stomach in adults and children 12 years of age and older. Bismuth subsalicylate is in a class of medications called antidiarrheal agents. It works by decreasing the flow of fluids and electrolytes into the bowel, reduces inflammation within the intestine, and may kill the organisms that can cause diarrhea.

Related Packages: 41167-4000-02
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Bismuth Subsalicylate

Product Information

NDC	41167-4000
Product ID	41167-4000_451f4235-7a9b-4eb8-b547-72e0d869b166
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Kaopectate Regular Strength Vanilla Flavor Anti Diarrheal
Proprietary Name Suffix	n/a
Non-Proprietary Name	bismuth subsalicylate
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	ORAL
Active Ingredient Strength	262
Active Ingredient Units	mg/15mL
Substance Name	BISMUTH SUBSALICYLATE
Labeler Name	Chattem, Inc.
Pharmaceutical Class	Bismuth [CS], Bismuth [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part335
Listing Certified Through	2023-12-31

Package

Package Images

NDC 41167-4000-02 (41167400002)

Pricing Information	N/A
NDC Package Code	41167-4000-2
Billing NDC	41167400002
Package	236 mL in 1 BOTTLE (41167-4000-2)
Marketing Start Date	2003-04-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL f577d526-ec77-4dca-9428-483b4581bf52 Details

SPL UNCLASSIFIED SECTION

Active Ingredient

(per 15mL):

Bismuth subsalicylate 262 mg

Purpose

Anti-diarrheal

Upset stomach reliever

Uses

traveler’s diarrhea
diarrhea
upset stomach due to overindulgence in food and drink
heartburn
indigestion
nausea
gas

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: potassium 5 mg, sodium 9 mg
each 15 mL tablespoonful contains: total salicylates 130 mg
do not use if inner seal is broken or missing

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

Made in Canada

CHATTEM® www.chattem.com

Principal Display Panel

Bismuth Subsalicylate

Kaopectate®

Multi-Symptom Relief

Anti-Diarrheal
Upset Stomach Reliever

Contains Salicylates

Vanilla

Regular Flavor

262 mg bismuth subsalicylate per 15 mL

8 fl oz (236 mL)

INGREDIENTS AND APPEARANCE

KAOPECTATE REGULAR STRENGTH VANILLA FLAVOR ANTI DIARRHEAL

bismuth subsalicylate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41167-4000
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE)	BISMUTH SUBSALICYLATE	262 mg in 15 mL

Ingredient Name	Strength
Inactive Ingredients
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
Shape		Size
Flavor	VANILLA	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:41167-4000-2	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2003
2	NDC:41167-4000-4	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2003

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part335	04/01/2003

Labeler - Chattem, Inc. (003336013)

Revised: 4/2003

Document Id: 451f4235-7a9b-4eb8-b547-72e0d869b166

Set id: f577d526-ec77-4dca-9428-483b4581bf52

Version: 6

Effective Time: 20030401