GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [WALGREEN COMPANY]

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GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [WALGREEN COMPANY]
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NDC 0363-0077-18, 0363-0077-36
Set ID 310d14be-e7ea-44b8-8b04-cffa39440d50
Category HUMAN OTC DRUG LABEL
Packager WALGREEN COMPANY
Generic Name
Product Class alpha-Adrenergic Agonist
Product Number
Application Number NDA021585
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each extended-release tablet)Purposes

    Guaifenesin 600 mg

    Expectorant

    Pseudoephedrine HCl 60 mg

    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

    •
    Tamper evident: Do not use if carton is open or if printed seal on blister is broken or missing.
    •
    store between 20-25°C (68-77°F)
  • Inactive ingredients

    carbomer homopolymer type B; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

  • Questions?

    (1-800-406-7984)

    You may also report side effects to this phone number.

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY: WALGREEN CO.
    200 WILMOT RD., DEERFIELD, IL 60015

  • PRINCIPAL DISPLAY PANEL - 600 mg/60 mg Tablet Blister Pack Carton

    Walgreens

    Compare to Mucinex® D
    active ingredients††

    12 HOUR
    EXTENDED-RELEASE TABLETS

    NDC 0363-0077-18

    Mucus
    Relief D

    GUAIFENESIN 600 mg &
    PSEUDOEPHEDRINE HCl 60 mg
    EXTENDED-RELEASE TABLETS
    EXPECTORANT & NASAL DECONGESTANT

    12 HOUR

    •
    Clears nasal & sinus congestion
    •
    Thins & loosens mucus
    •
    Immediate & extended release

    18
    EXTENDED-RELEASE
    TABLETS

    ACTUAL SIZE

    PRINCIPAL DISPLAY PANEL - 600 mg/60 mg Tablet Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE 
    guaifenesin and pseudoephedrine hydrochloride tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0077
    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
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeOVALSize16mm
    FlavorImprint Code xeuMnci;600
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0077-181 in 1 CARTON08/01/2017
    118 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0363-0077-362 in 1 CARTON08/01/2017
    218 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02158508/01/2017
    Labeler - WALGREEN COMPANY (008965063)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ohm Laboratories Inc.184769029MANUFACTURE(0363-0077)
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