KAOPECTATE- bismuth subsalicylate tablet, coated

Kaopectate by

Drug Labeling and Warnings

Kaopectate by is a Otc medication manufactured, distributed, or labeled by Kramer Laboratories, Contract Pharmacal Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

• Active ingredient (per caplet): Purposes
• Bismuth subsalicylate 262 mg: Anti-diarrheal, Upset stomach reliever

INDICATIONS & USAGE

Uses relieves:

• traveler’s diarrhea
  
• diarrhea
• upset stomach due to overindulgence in food and drink, including:
  • heartburn
  • indigestion
    
  • nausea
    
  • gas
    
  • belching
    
  • fullness
    
  
  
  

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 (1 dose)
  
• swallow caplets with water; do not chew
  
• 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 caplet contains very low sodium
  
• 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-25º C (68º-77º F)

Inactive ingredients

croscarmellose sodium, crospovidone, hydrated silica, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, povidone, sodium lauryl sulfate, stearic acid, talc, titanium dioxide, triacetin

  

Principal Display Panel

FAST & EFFECTIVE RELIEF
Kaopectate®
Bismuth Subsalicylate

 Anti-Diarrheal  Upset Stomach Reliver

Diarrhea & 
Upset Stomach

✓ Begins controlling symptoms from the first dose
✓ Quickly relieves urgency, gas, and cramping
✓ Effective on diarrhea from bacteria, viruses, and other causes

CLINICALLY PROVEN MEDICINE

28 Coated Caplets

LOT

EXP

Do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken.

Kramer Laboratories, Inc.
Bridgewater, NJ 08807
1-800-824-4894

14711-07-20_K0720

Kaopectate®
Bismuth Subsalicylate

• Anti-Diarrheal
• Upset Stomach Reliever

Diarrhea &  Upset Stomach

28 Coated Caplets

Do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken.

KEEP CARTON AS IT CONTAINS IMPORTANT INFORMATION

Kramer Laboratories, Inc.
Bridgewater, NJ 08807
1-800-824-4894

14712-07-20_K0720

INGREDIENTS AND APPEARANCE

KAOPECTATE 
bismuth subsalicylate tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55505-197
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)
Hypromellose, Unspecified (UNII: 3NXW29V3WO)
Magnesium Stearate (UNII: 70097M6I30)
Microcrystalline Cellulose (UNII: OP1R32D61U)
Mineral Oil (UNII: T5L8T28FGP)
Povidone, Unspecified (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	K
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55505-197-07	1 in 1 CARTON	10/01/2020
1		28 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 55505-197-70	1 in 1 CARTON	02/01/2021
2		42 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 Drug	M008	10/01/2020

Labeler - Kramer Laboratories (122720675)