BIO-G-TUSS PEDIATRIC DROPS (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [ADVANCED GENERIC CORPORATION]

BIO-G-TUSS PEDIATRIC DROPS (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [ADVANCED GENERIC CORPORATION]
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NDC 45737-240-02
Set ID 42045759-eaf2-4ffb-8a68-043f661acf8a
Category HUMAN OTC DRUG LABEL
Packager Advanced Generic Corporation
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • Active ingredients

    Dextromethorphan HBr

    Guaifenesin

    Phenylephrine HCl

  • Purpose

    Cough Suppressant

    Expectorant

    Nasal Decongestant

  • Uses

    • helps lossen phlegm (mucus) and thin bronchial secretions to drain broncial tubes and make coughs more productive
    • temporarily relieves nasal congestion due to hay fever or other respiratory allergies (allergic rhinitis) and cough due to minor throat and bronchial irritation as may occur with the common cold
  • Warnings

    Do not exceed recommended dosage

    • If nervousness dizziness, or sleeplessness ocurs, discontinue use and consult a doctor
    • If symptoms do not improve wihtin 7 days or are accompanied by fever, consult a doctor.

    Do not use this product

    • for persistant or chronic cough such as occurs with asthma, or if cough is accompanied by excessive phlegm (mucus), unless directed by a doctor
    • in a child who is taking a prescription Monoaminooxidase Inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for two weeks after stopping the MAOI drug; if you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
    • Do not give this product to a child who has heart disease, high blood pressure, thyroid disease, or diabetes, unless directed by a doctor.

    Stop use and ask a doctor

    • A persistent cough may be a sign of a serious condition
    • if cough persists for more than onweek, tend to recur, or is accompanied by fever, rash or persistent headache, consult a doctor.
  • Keep out of reach of children

    Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

  • Directions

     AgeDose 
     children 6 to under 12 years of age2 mL every 6-8 hours 
     chidren 2 to under 6 years of age1 mL every 6-8 hours 
     children under 2 years of ageconsult a doctor 

  • Inactive ingredients

    citric acid, grape flavor, glycerin, methylparaben, polyethylene glycol, propylparaben, purified water, sodium citrate, sucralose.

  • Questions or Comments

    1-305-403-3788

  • PRINCIPAL DISPLAY PANEL

    BioGTussPedDrops

  • INGREDIENTS AND APPEARANCE
    BIO-G-TUSS  PEDIATRIC DROPS
    dextromethorphan hbr, guaifenesin, phenylephrine hcl solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45737-240
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE7.5 mg  in 1 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN88 mg  in 1 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE2.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45737-240-0260 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product04/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/01/2016
    Labeler - Advanced Generic Corporation (831762971)

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