BIOPHEX TR (GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [ADVANCED GENERIC CORPORATION]

BIOPHEX TR (GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [ADVANCED GENERIC CORPORATION]
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NDC 45737-606-10
Set ID 81a4cf27-585b-484b-b0d8-4e21b4016418
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 tablet)           Purpose

    Guaifenesin .............. 388 mg .................  Expectorant

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

  • PURPOSE

    Purpose

    Expectorant

    Nasal Decongestant

  • INDICATIONS & USAGE

    Uses

    Temporarily relieves these symptoms associated with a cough, the common cold, hay fever, or other upper respiratory allergies

    • helps loosen phlegm (mucus)
    • loosens nasal congestions
    • thin bronchial secretions
    • drain bronchial tubes
    • make coughs more productive
    • clears stuffy nose
    • clear nasal passageways
    • shrinks swollen membranes
  • WARNINGS

    Warnings

    Do not exceed recommended dosage

    Do not use this product if you are taking a 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 are uncertain whether your prescription drug contains an MAOI, ask a health professional.

    Ask a doctor before use if you have:

    • heart disease
    • excessive phlegm (mucus)
    • high blood pressure
    • diabetes
    • thyroid disease
    • difficulty in urination due to enlargement of the prostate gland
    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • STOP USE

    Stop use and ask a doctor if:

    • Nervousness, dizziness, or sleeplessness occurs
    • symptoms are accompanied by fever, rash, persistent headache, or excessive phlegm (mucus)
    • cough and congestion do not improve within 7 days or are accompanied by fever or symptoms tend to recur
  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Directions: Do not exceed recommended doses in a 24-hour period

    Adults and children 12 years of age and over              1 tablet every 4 hours. Do not exceed 6 tablets in 24 hours

    Children 6 to 12 years of age                                       1/2 tablet every 4 hours. Do not exceed 3 tablets in 24 hours

    Children under 6 years of age                                      Ask a doctor

  • INACTIVE INGREDIENT

    Inactive ingredients: Colloidal silicon dioxide, crocarmellose sodium, hydroxy propyl methyl cellulose (HPMC), microcrystalline cellulose, polyethylene glycol 400 (PEG-400), povidone, pregelatinized starch, stearic acid, talc

  • QUESTIONS

    Questions or comments? 305-403-3788

  • PRINCIPAL DISPLAY PANEL

    biophex label

  • INGREDIENTS AND APPEARANCE
    BIOPHEX  TR
    guaifenesin, phenylephrine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45737-606
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN388 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize18mm
    FlavorImprint Code BP;AGC
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45737-606-10100 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/01/2014
    Labeler - Advanced Generic Corporation (831762971)

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