ED BRON GP (GUAIFENESIN AND PHENYLEPHRINE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]

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ED BRON GP (GUAIFENESIN AND PHENYLEPHRINE) LIQUID [EDWARDS PHARMACEUTICALS, INC.]
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NDC 0485-0208-16
Set ID b1fca5aa-d877-45e0-b074-dcbc6af94ee3
Category HUMAN OTC DRUG LABEL
Packager EDWARDS PHARMACEUTICALS, INC.
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredients
    (in each 5 mL teaspoonful)     		Purpose
    Guaifenesin 100 mgExpectorant
    Phenylephrine HCl 5 mgNasal 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:0485-0208
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColororangeScore    
    ShapeSize
    FlavorORANGEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0485-0208-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/01/2012
    Labeler - EDWARDS PHARMACEUTICALS, INC. (195118880)
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