Kola-Pectin DS

Dosage form: liquid
Ingredients: BISMUTH SUBSALICYLATE 525mg in 15mL
Labeler: Seyer Pharmatec, Inc.
NDC Code: 11026-2639

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active Ingredients(in each 15mL - 1 tablespoonful) ......................................... Purpose

Bismuth Subsalicylate 525 mg ..................................................... Upset stomach reliever/ antidiarrheal

Uses:

  • relieves
  • heartburn
  • indigestion
  • upset stomach
  • nausea
  • diarrhea

Warnings:

Reyes'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.


Allergies 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

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

If pregnant or breast-feeding, ask a health professional before use.

Directions:

  • Shake well before each use
  • For accurate dosing, use dose cup
  • Adults and children 12 years and over: 1 dose (2 tbsp or 30 ml) every hour as needed. Do not exceed 4 doses (8 tbsp or 120 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

When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur.

Stop use ans ask a doctor if:

  • symptoms get worse
  • ringing in ears or loss of hearing occurs
  • diarrhea last more than 2 days
Other Information
  • store at room temperature
  • contains 198.7 mg / 15 ml of salicylate


Active Ingredients: magnesium aluminum silicate, kaolin, xanthan gum, sodium saccharin, potassium sorbate, sodium propionate, caramel color, methylparaben, natural banana flavor, glycerine and water.

Questions and/or comments, please call (888) 782-3585

Seyer Pharmatec, Inc.

Guaynabo, Puerto Rico 00970

KOLA-PECTIN  DS
bismuth subsalicylate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11026-2639
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (BISMUTH SUBSALICYLATE) BISMUTH SUBSALICYLATE525 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM ALUMINUM SILICATE 
KAOLIN 
XANTHAN GUM 
SACCHARIN SODIUM 
POTASSIUM SORBATE 
SODIUM PROPIONATE 
METHYLPARABEN 
GLYCERIN 
WATER 
Product Characteristics
Color    Score    
ShapeSize
FlavorBANANA (Natural Banana Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:11026-2639-4118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33510/01/2007
Labeler - Seyer Pharmatec, Inc. (832947126)
Registrant - Seyer Pharmatec, Inc. (832947126)
Establishment
NameAddressID/FEIOperations
Sonar Products, Inc.104283945manufacture

Revised: 01/2012
 
Seyer Pharmatec, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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