BIOBRON DX (DEXTROMETHORPHAN, GUAIFENESIN, PHENYLEPHRINE) LIQUID [ADVANCED GENERIC CORPORATION]

BIOBRON DX (DEXTROMETHORPHAN, GUAIFENESIN, PHENYLEPHRINE) LIQUID [ADVANCED GENERIC CORPORATION]
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NDC 45737-246-16
Set ID c2f176e9-b647-43a6-96cd-bad48dd776e9
Category HUMAN OTC DRUG LABEL
Packager Advanced Generic Corporation
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • ACTIVE INGREDIENT

    Active Ingredients: (in each 5 mL tsp.)              Purpose

    Dextromethorphan Hydrobromide 20 mg.................. Cough Suppressant

    Guaifenesin 200 mg .............................................. Expectorant

    Phenylephrine HCl 10 mg.................................. Nasal Decongestant

  • PURPOSE


    Uses

    • Temporarily relieves these symptoms, due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies
    • Cough due to minor throat and bronchial irritation
    • Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make cough more productive
    • Nasal congestion
    • Reduces swelling of nasal passages.
  • WARNINGS

    Warnings

    • Do not exceed recommended dosage
    • A persistent cough may be a sign of a serious condition. If cough persists for more than a week, tends to reoccur or is accompanied by a fever, rash or persistent headache, consult a doctor
    • If nervousness, dizziness or sleeplessness occur, discontinue use and consult a doctor
    • If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor.
  • DO NOT USE

    Do not Use

    • For persistent cough such as occurs with smoking, asthma, chronic bronchitis, emphysema or where cough is accompanied by excessive phelgm (mucus), unless directed by a doctor  
    • If nervousness, dizziness or sleeplessness occur, discontinue use and consult a doctor.

    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 you are taking a prescription drug that contains an MAOI;
    ask your doctor or pharmacist before taking this product.

  • KEEP OUT OF REACH OF CHILDREN

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

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • DOSAGE & ADMINISTRATION


    Directions Do not exceed 6 doses in 24 hours.

     adults and children
     12 years of age and over
     take 1 teaspoonful (5 mL)
     every 4 hours
    children 6 to under
     12 years of age
     take 1/2 teaspoonful (2.5 mL)
     every 4 hours
     children under 6 years of age

     ask a doctor



  • INDICATIONS & USAGE

    Other information  store at room temperature 15 - 30 degrees celcius (59 - 86 degrees farhenheits).

    Tamper Evident Feature:
    Do not use if seal under cap (or cello-band over cap) is torn, broken or missing.

  • QUESTIONS

    Questions or comments? 1-305-403-3788
    Manufactured For: Advanced Generic Corporation, Miami, FL 33166.
    www.advancedgeneric.com

  • INACTIVE INGREDIENT

    Inactive ingredients glycerin, propylene glycol, methylparaben, propylparaben, citric acid, sodium citrate, saccharin calcium,
    cherry flavor, purified water.

  • PRINCIPAL DISPLAY PANEL

    BiobronDXLabel

  • INGREDIENTS AND APPEARANCE
    BIOBRON  DX
    dextromethorphan, guaifenesin, phenylephrine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45737-246
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide20 mg  in 5 mL
    Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin200 mg  in 5 mL
    Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride10 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SACCHARIN CALCIUM (UNII: 5101OP7P2I)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRY (Cherry Flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45737-246-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/01/2009
    Labeler - Advanced Generic Corporation (831762971)