Kaopectate Regular Strength Vanilla Flavor Anti Diarrheal (Bismuth Subsalicylate) Liquid [Physicians Total Care, Inc.] -

KAOPECTATE REGULAR STRENGTH VANILLA FLAVOR ANTI DIARRHEAL (BISMUTH SUBSALICYLATE) LIQUID [PHYSICIANS TOTAL CARE, INC.]
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NDC	54868-2298-1
Set ID	db9c4b93-d5f2-4237-973e-75535024b9f5
Category	HUMAN OTC DRUG LABEL
Packager	Physicians Total Care, Inc.
Generic Name
Product Class
Product Number
Application Number	PART335

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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

INGREDIENTS AND APPEARANCE

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH SUBSALICYLATE - UNII:62TEY51RR1)	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	Marketing End Date
Packaging
1	NDC:54868-2298-1	236 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part335	05/12/2008

Labeler - Physicians Total Care, Inc. (194123980)

Name	Address	ID/FEI	Business Operations
Establishment
Physicians Total Care, Inc.		194123980	relabel

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Medic

KAOPECTATE REGULAR STRENGTH VANILLA FLAVOR ANTI DIARRHEAL (BISMUTH SUBSALICYLATE) LIQUID [PHYSICIANS TOTAL CARE, INC.]

Reye’s Syndrome:

Allergy Alert: Contains salicylate.

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

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

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