G-BRONCO-D (GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SUSPENSION [MCLAREN MEDICAL INC]

G-BRONCO-D (GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SUSPENSION [MCLAREN MEDICAL INC]
PDF | XML

NDC 43913-403-16
Set ID 632d4219-7c36-4ed1-a5d0-7d0021b778a9
Category HUMAN OTC DRUG LABEL
Packager MCLAREN MEDICAL INC
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • 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)

Related Drugs