Label: G-BRONCO-D- guaifenesin, dextromethorphan hydrobromide, and phenylephrine hydrochloride suspension

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 Label Information

Updated June 29, 2015

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredients (in each 5mL)Purpose
    Guaifenesin 200 mgExpectorant
    Dextromethorphan 10 mgAntitussive
    Phenylephrine 5 mgNasal Decongestant
  • Uses

    • Temporarily relieves cough due to minor throat and bronchial irritations as may occur with the common cold
    • For the temporary relief of nasal congestion due to the common cold
    • Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • Warnings

    Do not exceed recommended dosage.

    If nervousness, dizziness, or sleeplessness occurs, discontinue use and consult a doctor.

    If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor.

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

    A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.

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

    Do not use 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.

    If pregnant or breast-feeding, ask a health professional before use. In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

    Keep this and all drugs out of the reach of children.

  • Directions

    • Do not take more than 6 doses in any 24-hour period.
    Adults and children 12 years of age and over2 teaspoons every 4 hours
    Children 6 to under 12 years of age1 teaspoon every 4 hours
    Children 2 to under 6 years of age½ teaspoon every 4 hours
    Children under 2 years of ageConsult a physician
  • Inactive ingredients

    Citric acid, flavor, hydroxymethylcellulose, methylparaben, polysorbate, propylene glycol, propylparaben, purified water, sorbitan monooleate, sorbitol and sucralose.

  • Other information

    Store at 20°-25°C (68°-77°F)

    Do not refrigerate

  • PRINCIPAL DISPLAY PANEL - 474 mL Bottle Label

    NDC-43913-403-16

    G-Bronco-D
    Suspension

    New Formula

    Cough Suppressant • Expectorant • Decongestant
    Sugar Free • Phenylalanine Free • Alcohol Free

    Cherry Flavor

    16 FL OZ (474 mL)

    Multiple Dose Unit Package
    For Dispensing Under Pharmaceutical Supervision Only

    McLaren Medical

    Principal Display Panel - 474 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    G-BRONCO-D 
    guaifenesin, dextromethorphan hydrobromide, and phenylephrine hydrochloride suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43913-403
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 5 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 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)  
    HYDROXYMETHYL CELLULOSE (UNII: 273FM27VK1)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43913-403-16474 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34107/01/2012
    Labeler - MCLAREN MEDICAL INC (013770591)
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