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

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  • 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
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  • 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)
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