Label: BIOPHEX TR- guaifenesin, phenylephrine hcl tablet

  • 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 May 30, 2014

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  • 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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