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

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
  • 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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