KAOPECTATE REGULAR STRENGTH PEPPERMINT FLAVOR ANTI DIARRHEAL- bismuth subsalicylate liquid KAOPECTATE EXTRA STRENGTH PEPPERMINT FLAVOR ANTI DIARRHEAL- bismuth subsalicylate liquid

Kaopectate Extra Strength Peppermint Flavor Anti Diarrheal by

Drug Labeling and Warnings

Kaopectate Extra Strength Peppermint Flavor Anti Diarrheal by is a Otc medication manufactured, distributed, or labeled by Chattem, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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, red 40, sodium salicylate, sorbic acid, sucrose, water, xanthan gum (245-243)

Dist. by CHATTEM, INC.

P.O. Box 2219

Chattanooga, TN 37409 USA

© 2008 Chattem, Inc.

Made in Canada

CHATTEM® www.chattem.com 

Active Ingredient

(per 15mL):

Bismuth subsalicylate 525 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 hour as needed
  
• do not exceed 4 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 5 mg
  
•  each 15 mL tablespoonful contains: total salicylates 236 mg
  
•  do not use if inner seal is broken or missing
  
•  low sodium

Inactive Ingredients

caramel, carboxymethylcellulose sodium, flavor, microcrystalline cellulose, red 40, sodium salicylate, sorbic acid, sucrose, water, xanthan gum (245-242)

Dist. by CHATTEM, INC.

P.O. Box 2219

Chattanooga, TN 37409 USA

© 2008 Chattem, Inc.

Made in Canada

CHATTEM® www.chattem.com

Principal Display Panel

Bismuth Subsalicylate

Kaopectate® 

• Anti-Diarrheal
  
• Upset Stomach Reliever

Goes to the Source to Help Relieve Diarrhea

Contains Salicylates

Peppermint

262 mg bismuth subsalicylate per 15 mL

8 fl oz (236 mL)

0071003-02

   

  

Principal Display Panel

Kaopectate®

Bismuth Subsalicylate

EXTRATM 

Strength

• Anti-Diarrheal
  
• Upset Stomach Reliever

Goes to the Source to Help Relieve Diarrhea

Contains Salicylates

Peppermint

525 mg bismuth subsalicylate per 15 mL

8 fl oz (236 mL)

0071004-02

 

INGREDIENTS AND APPEARANCE

KAOPECTATE REGULAR STRENGTH PEPPERMINT FLAVOR ANTI DIARRHEAL 
bismuth subsalicylate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-3330
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE)	BISMUTH SUBSALICYLATE	17.47 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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	PEPPERMINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-3330-1	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2003
2	NDC: 41167-3330-3	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2003

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

KAOPECTATE EXTRA STRENGTH PEPPERMINT FLAVOR ANTI DIARRHEAL 
bismuth subsalicylate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-7449
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE)	BISMUTH SUBSALICYLATE	35.0 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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	PEPPERMINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-7449-2	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2003

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

Labeler - Chattem, Inc. (003336013)