Label: GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE tablet, extended release

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated June 21, 2019

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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:
    Sun Pharmaceutical Industries, Inc.
    Cranbury, NJ 08512

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

    †Compare To
    the active ingredients of
    Mucinex® D

    NDC 51660-071-36

    ohm®

    Guaifenesin 600 mg
    & Pseudoephedrine HCl 60 mg
    Extended-Release Tablets

    Expectorant & Nasal Decongestant

    12 Hour

    • Clears Nasal/Sinus Congestion
    • Thins and Loosens Mucus
    • Immediate and Extended Release

    36 Extended-Release Tablets

    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:51660-071
    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:51660-071-181 in 1 CARTON12/10/2017
    118 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:51660-071-362 in 1 CARTON12/10/2017
    218 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02158511/15/2017
    Labeler - OHM LABORATORIES INC (184769029)
    Establishment
    NameAddressID/FEIBusiness Operations
    RECKITT BENCKISER HEALTHCARE INTERNATIONAL LTD230780363MANUFACTURE(51660-071)
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