KAOPECTATE- bismuth subsalicylate tablet

Kaopectate by

Drug Labeling and Warnings

Kaopectate by is a Otc medication manufactured, distributed, or labeled by Chattem, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Kaopectate

Active ingredient (per caplet)

Bismuth subsalicylate 262 mg

Purpose

Anti-diarrheal, Upset stomach reliever

Uses

• relieves diarrhea
  
• relieves travelers' 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

• anticoagulation (thinning the blood)
  
• diabetes
  
• gout
  
• arthritis

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

• adults and children 12 years of age and older: 2 caplets
  
• swallow caplets with water; do not chew
  
• repeat does 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 caplet contains: total salicylates 99 mg
  
• do not use if carton was opened or if printed foil inner seal under bottle cap is torn or missing
  
• store at room temperature 20º-25ºC (68º-77º F)

Inactive Ingredients

croscarmellose sodium, crospovidone, hydrated silica, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, pharmaceutical ink, povidone, sodium lauryl sulfate, stearic acid, talc, titanium dioxide, triacetin (309-034)

Distributed by:
Chattem, Inc.
P.O. Box 2219
Chattanooga, TN
37409-0219
USA © 2013

  

Principal Display Panel

Bismuth Subsalicylate

Kaopectate®

• Multi-Symptom Relief
  
• Anti-Diarrheal
  
• Upset Stomach Reliever

Relieves 7 types of Stomach Ailments:

• Diarrhea
  
• Upset Stomach
  
• Nausea
  
• Gas
  
• Heartburn
  
• Travelers" Diarrhea
  
• Indgestion

28 Coated Caplets

INGREDIENTS AND APPEARANCE

KAOPECTATE 
bismuth subsalicylate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-4002
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CROSPOVIDONE (UNII: 2S7830E561)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MINERAL OIL (UNII: T5L8T28FGP)
POVIDONE (UNII: FZ989GH94E)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL (caplet)	Size	17mm
Flavor		Imprint Code	Kaopectate
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-4002-5	1 in 1 CARTON	04/01/2013
1		28 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part335	04/01/2013

Labeler - Chattem, Inc. (003336013)