KAOPECTATE- bismuth subsalicylate tablet, chewable

Kaopectate by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

• Active ingredient (per chew): 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 chews (1 dose)
• 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 soft chew 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-25º C (68º-77º F)

Inactive ingredients

calcium carbonate, confectioner’s sugar, corn syrup, corn syrup solids, FD&C red #40 aluminum lake, glycerin, hydrogenated coconut oil, natural masking flavor, soy lecithin, strawberry flavor, sucrose, water

  

PRINCIPAL DISPLAY PANEL

GREAT TASTE!

FAST & EFFECTIVE RELIEF

Kaopectate®
Bismuth Subsalicylate  Anti-Diarrheal  Upset Stomach Reliever

Soft Chews

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

24 Soft Chews
Individually wrapped

Strawberry Flavor

FAST & EFFECTIVE RELIEF

Do not take maximum dose for more than 2 days per week.

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

502851

INGREDIENTS AND APPEARANCE

KAOPECTATE 
bismuth subsalicylate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55505-206
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
Calcium Carbonate (UNII: H0G9379FGK)
Sucrose (UNII: C151H8M554)
Corn Syrup (UNII: 9G5L16BK6N)
Fd&C Red No. 40 (UNII: WZB9127XOA)
Glycerin (UNII: PDC6A3C0OX)
Hydrogenated Coconut Oil (UNII: JY81OXM1OM)
Lecithin, Soybean (UNII: 1DI56QDM62)
Water (UNII: 059QF0KO0R)

Product Characteristics
Color	PINK	Score	no score
Shape	RECTANGLE	Size	23mm
Flavor	STRAWBERRY	Imprint Code	K
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55505-206-69	1 in 1 CARTON	02/01/2021
1		24 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	02/01/2021

Labeler - Kramer Laboratories (122720675)