GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE EXTENDED RELEASE (GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PROFICIENT RX LP]

GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE EXTENDED RELEASE (GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PROFICIENT RX LP]
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NDC 63187-960-18
Set ID a4a9f535-3674-450c-b84b-b65ca1654cfb
Category HUMAN OTC DRUG LABEL
Packager Proficient Rx LP
Generic Name
Product Class alpha-Adrenergic Agonist
Product Number
Application Number ANDA091071
  • Active ingredients (in each extended-release tablet)

    Guaifenesin 600 mg

    Pseudoephedrine HCl 60 mg

  • Purpose

    Expectorant

    Nasal Decongestant

  • Uses

    helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
    temporarily relieves nasal congestion due to:
    common cold
    hay fever
    upper respiratory allergies
    temporarily restores freer breathing through the nose
    promotes nasal and/or sinus drainage
    temporarily relieves sinus congestion and pressure
  • Warnings

  • 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.

  • Ask a doctor before use if you have

    heart disease
    high blood pressure
    thyroid disease
    diabetes
    trouble urinating due to an enlarged prostate gland
    persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
    cough accompanied by too much phlegm (mucus)
  • When using this product

    do not use more than directed
  • Stop use and ask a doctor if

    you get nervous, dizzy, or sleepless
    symptoms do not get better within 7 days, come back or occur with a fever, rash, or persistent headache.

    These could be signs of a serious illness.

  • If pregnant or breast-feeding,

    ask a health professional before use.

  • Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

  • Directions

    do not crush, chew, or break tablet
    take with a full glass of water
    this product can be administered without regard for timing of meals
    adults and children 12 years and older: 2 tablets every 12 hours; not more than 4 tablets in 24 hours
    children under 12 years of age: do not use
  • Other information

    store between 20-25°C (68-77°F)
    do not use if blister unit is broken or torn
  • Inactive ingredients

    colloidal silicon dioxide, copovidone, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, sodium starch glycolate, stearic acid

  • Questions or comments?

    1-800-719-9260

  • Package/Label Principal Display Panel

    Compare to Mucinex® D active ingredient

    Guaifenesin and Pseudoephedrine Hydrochloride Extended-Release Tablets, 600 mg/60 mg

    Expectorant/Nasal Decongestant

    12 HOUR

    Clears Nasal/Sinus Congestion

    Thins and Loosens Mucus

    Actual Size

    18 Extended-Release Tablets

    Relabeled by:

    Proficient Rx LP

    Thousand Oaks, CA 91320

    63187-960-18
  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE EXTENDED RELEASE 
    guaifenesin, pseudoephedrine hydrochloride tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-960(NDC:45802-230)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN600 mg
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE60 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    COPOVIDONE K25-31 (UNII: D9C330MD8B)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorORANGE (peach) Scoreno score
    ShapeOVAL (biconvex) Size18mm
    FlavorImprint Code 600;Watson
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63187-960-1818 in 1 CARTON01/01/2018
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09107101/29/2016
    Labeler - Proficient Rx LP (079196022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Proficient Rx LP079196022RELABEL(63187-960)