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 January 27, 2023

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENS

    (in each extended-release tablet)

    Guaifenesin USP, 600 mg

    Pseudoephedrine HCL USP, 60 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 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 600mg and 60mg: 2 tablets every 12 hours; not more than 4 tablets in 24 hours

    For 1200mg and 120mg: 1 tablet every 12 hours; not more than 2 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

    1200-120-mg-foil1200-120-mg-carton600-60-mg-foil600-60-mg-carton

  • INGREDIENTS AND APPEARANCE
    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
    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
    Labeler - Granules India Ltd (915000087)