Label: GUAIFENESIN AND PSEUDOEPHEDRINE HCL tablet, extended release

  • NDC Code(s): 62207-827-72, 62207-828-71
  • Packager: Granules India Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 18, 2024

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  • Active ingredients (in each extended-release tablet)

    (For 600 mg/60 mg)

    Guaifenesin USP, 600 mg

    Pseudoephedrine HCL USP, 60 mg


    (For 1200 mg/120 mg)


    Guaifenesin USP, 1200 mg
    Pseudoephedrine HCL USP, 120 mg

  • Purposes

    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 Centre right away (1-800 222-1222).

  • Directions

    • do not crush, chew, or break extended-release 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:

    For 600 mg/60 mg: 2 extended-release tablets every 12 hours; not more than 4 extended-release tablets in 24 hours

    For 1200 mg/120 mg: 1 extended-release tablet every 12 hours; not more than 2 extended-release 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, cellulose microcrystalline, hypromellose, lake of FD&C yellow 6, magnesium stearate, sodium starch glycolate Type A

  • Questions or comments?

    Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST.

    You may also report side effects to this phone number.

    Keep the carton.
    It contains important information. See end panel for expiration date.

    Manufactured By:
    Granules India Limited
    Hyderabad – 500 081, INDIA

    MADE IN INDIA

    Distributed By:
    Granules USA, Inc.
    Parsippany, NJ 07054

  • PRINCIPAL DISPLAY PANEL 600 mg and 60 mg - Blister Foil Label

    ggf-pseudo-600mg-60mg-foil-label

  • PRINCIPAL DISPLAY PANEL 600 mg and 60 mg - Blister Carton Label

    NDC 62207-827-72†Compare To
    the active ingredients of
    Mucinex ® D

    Guaifenesin and
    Pseudoephedrine Hydrochloride     FOR DAY OR NIGHT

    Extended-Release Tablets12HR

    600 mg and 60 mg

    Guaifenesin 600 mg - Expectorant • Clears Nasal & Sinus Congestion
    Pseudoephedrine HCl     60 mg - Nasal Decongestant • Thins & Loosens Mucus
    • Immediate & Extended Release

    RELIEVES NASAL & CHEST CONGESTION


    90 (9x10) Extended-Release Tablets

    ggf-pseudo-600mg-60mg-blistercarton

  • PRINCIPAL DISPLAY PANEL 1200 mg and 120 mg - Blister Foil Label

    ggf-pseudo-1200mg-120mg-foil-label

  • PRINCIPAL DISPLAY PANEL 1200 mg and 120 mg - Blister Carton Label

    NDC 62207-828-71†Compare To
    the active ingredients of
    Mucinex ® D

    Guaifenesin and
    Pseudoephedrine Hydrochloride     FOR DAY OR NIGHT
    Extended-Release Tablets12HR

    1200 mg and 120 mg

    Guaifenesin 1200 mg - Expectorant • Clears Nasal & Sinus Congestion
    Pseudoephedrine HCl 120 mg - Nasal Decongestant • Thins & Loosens Mucus
    • Immediate & Extended Release

    RELIEVES NASAL & CHEST CONGESTION


    70 (7x10) Extended-Release Tablets

    ggf-pseudo-1200mg-120mg-blistercarton

  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN AND PSEUDOEPHEDRINE HCL 
    guaifenesin and pseudoephedrine hcl tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-827
    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
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
    HYPROMELLOSE 2910 (10000 MPA.S) (UNII: 0HO1H52958)  
    Product Characteristics
    Colororange (Light orange and orange colored) Scoreno score
    ShapeOVALSize16mm
    FlavorImprint Code GP;600
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62207-827-729 in 1 CARTON06/01/2023
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21608206/01/2023
    GUAIFENESIN AND PSEUDOEPHEDRINE HCL 
    guaifenesin and pseudoephedrine hcl tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-828
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN1200 mg
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE120 mg
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
    HYPROMELLOSE 2910 (10000 MPA.S) (UNII: 0HO1H52958)  
    Product Characteristics
    Colororange (Light orange and orange colored) Scoreno score
    ShapeOVALSize22mm
    FlavorImprint Code GP;1200
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62207-828-717 in 1 CARTON06/01/2023
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21608206/01/2023
    Labeler - Granules India Ltd (915000087)
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