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Kola-Pectin (Seyer Pharmatec, Inc.)

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LIQUID 118 mL in 1 BOTTLE (11026-2639-4) Label Information

Complete Kola-Pectin Information

  • 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


  • 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