KOLA-PECTIN DS- bismuth subsalicylate liquid

Kola-Pectin by

Drug Labeling and Warnings

Kola-Pectin by is a Otc medication manufactured, distributed, or labeled by Seyer Pharmatec, Inc., Sonar Products, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

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

PURPOSE

Uses:

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

WARNINGS

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.

DO NOT USE

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 REACH OF CHILDREN

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

PREGNANCY OR BREAST FEEDING

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

DOSAGE & ADMINISTRATION

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
  

INDICATIONS & USAGE

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
  

INACTIVE INGREDIENT

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

QUESTIONS

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

Seyer Pharmatec, Inc.

Guaynabo, Puerto Rico 00970

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

KOLA-PECTIN  DS
bismuth subsalicylate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11026-2639
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH SUBSALICYLATE - UNII:62TEY51RR1)	BISMUTH SUBSALICYLATE	525 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
KAOLIN (UNII: 24H4NWX5CO)
XANTHAN GUM (UNII: TTV12P4NEE)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM PROPIONATE (UNII: DK6Y9P42IN)
METHYLPARABEN (UNII: A2I8C7HI9T)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor	BANANA (Natural Banana Flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11026-2639-4	118 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part335	10/01/2007

Labeler - Seyer Pharmatec, Inc. (832947126)

Registrant - Seyer Pharmatec, Inc. (832947126)

Establishment
Name	Address	ID/FEI	Business Operations
Sonar Products, Inc.		104283945	manufacture