Label: GUAIFENESIN AND PSEUDOEPHEDRINE HCL tablet, extended release

  • NDC Code(s): 51660-074-18, 51660-077-12
  • Packager: Ohm Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 23, 2024

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  • ACTIVE INGREDIENT

    Active ingredients (in each extended-release tablet)

    Purposes

    Guaifenesin 600 mg

    Expectorant

    Pseudoephedrine HCl 60 mg

    Nasal Decongestant

    Active ingredients (in each extended-release tablet)

    Purposes

    Guaifenesin 1200 mg

    Expectorant

    Pseudoephedrine HCl 120 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 extended-release tablet
    • take with a full glass of water
    • this product can be administered without regard for timing of meals
    • For 600 mg/60 mg: adults and children 12 years and older: 2 extended-release tablets every 12 hours; not more than 4 extended-release tablets in 24 hours
    • For 1200 mg/120 mg: adults and children 12 years and older: 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, NF; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF

  • Questions?

    call toll-free Monday to Friday 8:30 am to 5:00 pm EST at 1-800-406-7984

    You may also report side effects to this phone number.

    Keep the carton. It contains important information.

    See end panel for expiration date.

    †Ohm ®is a registered trademark of Sun Pharmaceutical Industries, Inc. All other trademarks are property of their respective owners.

    Distributed by:
    Ohm Laboratories Inc.
    New Brunswick, NJ 08901

    0321

  • Guaifenesin 600 mg and Pseudoephedrine HCl 60 mg Extended-Release Tablets - Carton Label

    NDC 51660-074-18

    † Compare To
    the active ingredients of
    Mucinex ®D

    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

    18 Extended-Release Tablets

    †Ohm ®is a registered trademark of Sun Pharmaceutical Industries, Inc. All other trademarks are property of their respective owners.

    guaif-pseuso

  • Guaifenesin 1200 mg and Pseudoephedrine HCl 120 mg Extended-Release Tablets - Carton Label

    NDC 51660-077-12

    † Compare To
    the active ingredients of

    Maximum Strength
    Mucinex ®D

    ohm ®

    Maximum Strength
    Guaifenesin 1200 mg & Pseudoephedrine HCl 120 mg
    Extended-Release Tablets

    Expectorant & Nasal Decongestant

    12 Hour

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

    12 Extended-Release Tablets

    †Ohm ®is a registered trademark of Sun Pharmaceutical Industries, Inc. All other trademarks are property of their respective owners.

    guai-pseudo-02

  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN AND PSEUDOEPHEDRINE HCL 
    guaifenesin and pseudoephedrine hcl tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51660-074
    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)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYPROMELLOSE 2910 (10000 MPA.S) (UNII: 0HO1H52958)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    Colorwhite (white to off-white) Scoreno score
    ShapeOVALSize17mm
    FlavorImprint Code 058
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51660-074-181 in 1 CARTON04/01/2021
    118 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21254204/01/2021
    GUAIFENESIN AND PSEUDOEPHEDRINE HCL 
    guaifenesin and pseudoephedrine hcl tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51660-077
    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
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    HYPROMELLOSE 2910 (10000 MPA.S) (UNII: 0HO1H52958)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    Colorwhite (white to off-white) Scoreno score
    ShapeOVALSize22mm
    FlavorImprint Code 057
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51660-077-121 in 1 CARTON04/01/2021
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21254204/01/2021
    Labeler - Ohm Laboratories, Inc. (184769029)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ohm Laboratories, Inc.184769029manufacture(51660-074, 51660-077)
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