Kaopectate Cherry Flavor Anti Diarrheal by Kramer Laboratories / Trillium Health Care Products Inc. Drug Facts

Kaopectate Cherry Flavor Anti Diarrheal by

Drug Labeling and Warnings

Kaopectate Cherry Flavor Anti Diarrheal by is a Otc medication manufactured, distributed, or labeled by Kramer Laboratories, Trillium Health Care Products Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

KAOPECTATE CHERRY FLAVOR ANTI DIARRHEAL- bismuth subsalicylate liquid 
Kramer Laboratories

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Drug Facts

• Active ingredient (per 15 mL): Purposes
• Bismuth subsalicylate 262 mg: Anti-diarrheal ; Upset stomach reliever

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

• a sodium-restricted diet
  
• 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
• only use pre-measured dose cup
• adults and children 12 years of age and older:
  • 1 dose (30 mL) every ½ hour to 1 hour as needed.
  • do not exceed 8 doses (240 mL) 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 dose cup contains: sodium 9 mg
•  do not use if inner seal is broken or missing
  
•  store at room temperature 20º-25º C (68º-77º F)

Inactive Ingredients

caramel, carboxymethylcellulose sodium, flavor, FD&C Red No. 40 microcrystalline cellulose, sodium salicylate, sorbic acid, sucrose, water, xanthan gum

Principal Display Panel

Kaopectate®
Bismuth Subsalicylate

 Anti-Diarrheal Upset Stomach Reliever

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

8 fl oz (236 mL)

Cherry Flavor

201H140 

Peel

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

LOT EXP

P013H16000

   

  

KAOPECTATE CHERRY FLAVOR ANTI DIARRHEAL 
bismuth subsalicylate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55505-201
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  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
Caramel (UNII: T9D99G2B1R)
Carboxymethylcellulose Sodium, Unspecified Form (UNII: K679OBS311)
Fd&C Red No. 40 (UNII: WZB9127XOA)
Microcrystalline Cellulose (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	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55505-201-36	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M008	11/01/2020	11/30/2023

Labeler - Kramer Laboratories (122720675)

Establishment
Name	Address	ID/FEI	Business Operations
Trillium Health Care Products Inc.		255426306	manufacture(55505-201)

Revised: 12/2023

Document Id: ea6acf69-6aab-4c33-b53c-66cfa1112d60

34390-5

Set id: bff5ff79-174d-441d-969c-7f0f74e2ef4e

Version: 3

Effective Time: 20231220