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ED BRON GP (EDWARDS PHARMACEUTICALS, INC.)

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Dosage Form Package Information Links
LIQUID 473 mL in 1 BOTTLE, PLASTIC (0485-0208-16) Label Information

Complete ED BRON GP Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • ACTIVE INGREDIENT

    Active Ingredients
    (in each 5 mL teaspoonful)
    Purpose
    Guaifenesin 100 mg Expectorant
    Phenylephrine HCl 5 mg Nasal Decongestant

  • Uses

    temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other respiratory allergies:

    • runny nose
    • sneezing
    • itching of the nose or throat
    • itchy, watery eyes
    • nasal congestion
    • reduces swelling of nasal passages
    • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive

  • Warnings

    Do not exceed recommended dosage.

    Do not use this product
    • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

    Do not take this product, unless directed by a doctor, if you have
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • difficulty in urination due to enlargement of the prostate gland

    Do not take this product for persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.

    Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

    Stop use and ask a doctor if
    • nervousness, dizziness, or sleeplessness occur
    • cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition.
    • new symptoms occur

    If pregnant or breastfeeding, ask a health professional before use.

    Keep out of reach of children.

    In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.


  • Directions

    Do not exceed recommended dosage.

    Adults and children 12 years of age and over: 2 teaspoonfuls (10 mL) every 4 hours, not to exceed 12 teaspoonfuls in 24 hours, or as directed by a doctor.
    Children 6 to under 12 years of age: 1 teaspoonful (5 mL) every 4 hours, not to exceed 6 teaspoonfuls in 24 hours, or as directed by a doctor.
    Children under 6 years of age: Consult a doctor.

  • Other information

    Store at 59° - 86° F (15° - 30° C) [see USP for Controlled Room Temperature].


  • Inactive ingredients

    Citric Acid, Methyl Paraben, Orange Flavor, Potassium Citrate, Potassium Sorbate, Propyl Paraben, Propylene Glycol, Purified Water, Sorbitol Solution 70%, and Sucralose.


  • Question? Comments?

    Call 1-800-543-9560


  • PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

    ED Bron GP Liquid

    E

    NDC 0485-0208-16

    ED Bron GP
    Liquid

    Expectorant Nasal Decongestant

    Sugar Free Alcohol Free Dye Free

    Each teaspoonful (5 mL)
    for oral administration contains:

    Guaifenesin 100 mg
    Phenylephrine HCl 5 mg

    Orange Flavor

    Tamper evident by foil seal under cap.
    Do not use if foil seal is broken or
    missing.

    Manufactured for:
    EDWARDS
    Pharmaceuticals, Inc.
    Ripley, MS 38663

    16oz. (473 mL)

    PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

  • INGREDIENTS AND APPEARANCE
    ED BRON GP 
    guaifenesin and phenylephrine liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0485-0208
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 100 mg  in 5 mL
    PHENYLEPHRINE (UNII: 1WS297W6MV) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE 5 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color ORANGE Score     
    Shape Size
    Flavor ORANGE Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0485-0208-16 473 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 06/01/2012
    Labeler - EDWARDS PHARMACEUTICALS, INC. (195118880)