KOLA-PECTIN DS- bismuth subsalicylate liquid
Seyer Pharmatec, Inc.

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ)	BISMUTH SUBSALICYLATE	525 mg in 15 mL

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11026-2639-4	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2007	12/31/2012

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part335	10/01/2007	12/31/2012

Labeler - Seyer Pharmatec, Inc. (832947126)

Registrant - Seyer Pharmatec, Inc. (832947126)

Name	Address	ID/FEI	Business Operations
Establishment
PROPHARMA, INC.		038080933	manufacture(11026-2639)

Revised: 10/2021

Document Id: 53f3d772-7c01-4619-9576-c8298fb3c7a7

Set id: 5310c125-1b3b-4511-8a71-06aa42891dc1

Version: 2

Effective Time: 20211015

Seyer Pharmatec, Inc.