KAOPECTATE VANILLA FLAVOR ANTI DIARRHEAL- bismuth subsalicylate liquid

Kaopectate Vanilla Flavor Anti Diarrheal by

Drug Labeling and Warnings

Kaopectate Vanilla 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]

ACTIVE INGREDIENT

• Active ingredient (per 15 mL):

  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:
  
  • o heartburn
  • o indigestion
    
  • o nausea
    
  • o gas
    
  • o belching
    
  • o 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:
  • o 1 dose (30 mL) every 1/2 hour to 1 hour as needed.
  • o do not exceed 8 doses (240 mL) in 24 hours
  • o 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 6 mg and salicylate 135mg
  
• store at room temperature 20º-25º C (68º-77º F)

Inactive Ingredients

carboxymethylcellulose sodium, flavor, microcrystalline cellulose, purified water, sodium salicylate, sorbic acid, sucrose, xanthan gum

Principal Display Panel

NEW IMPROVED TASTE!

Kaopectate®
Bismuth Subsalicylate 262 mg
 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

11 fl oz (325mL)

Vanilla Flavor

68OVAN11KA0LF

Kaopectate® Vanilla 11oz

Do not use if inner seal is broken
or missing

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

Lot:


Exp:

PEEL CORNER TO READ COMPLETE
DRUG FACTS AND INFORMATION

680VAN11KA0LB

    

  

INGREDIENTS AND APPEARANCE

KAOPECTATE VANILLA FLAVOR ANTI DIARRHEAL 
bismuth subsalicylate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55505-198
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
Carboxymethylcellulose Sodium, Unspecified (UNII: K679OBS311)
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	VANILLA	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55505-198-36	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2020
2	NDC: 55505-198-64	325 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2022

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)