Label: GUAIFENESIN AND PSEUDOEPHEDRINE HCL tablet, extended release

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

Drug Label Information

Updated June 26, 2023

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  • Active ingredient(s)

    Guaifenesin USP, 600 mg................................................................................Expectorant

    Pseudoephedrine HCl USP, 60 mg......................................................Nasal Decongestant 

    Guaifenesin USP, 1200 mg................................................................................Expectorant

    Pseudoephedrine HCl USP, 120 mg......................................................Nasal Decongestant 

  • Purpose

    Expectorant and Nasal Decongestant

  • Use(s)

    ■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bother some 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

    ■ 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 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.

    Pregnancy/Breastfeeding

    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

    ■ children under 12 years of age: do not use

    ■ adults and children 12 years and older: 2 tablets every 12 hours; not more than 4 tablets in 24 hours 

  • Other information

    ■ tamper evident: do not use if carton is open or if printed seal on blister is broken or missing.

  • Storage

    ■ store between 20°-25°C (68°-77°F)

  • Inactive ingredients

    FD & C yellow #6, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide.

  • Questions

    call 1-888-375-3784

    You may also report side effect to this phone number.

    Keep the carton.

    It contains important information.

    See end panel for expiration date.

    Manufactured by:

    Dr. Reddy’s Laboratories Limited

    Srikakulam – 532 409 INDIA

  • Principal Display Panel

    Guaifenesin and Pseudoephedrine HCl ER Tablets 600 mg/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:70677-0110(NDC:55111-798)
    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
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeCAPSULESize17mm
    FlavorImprint Code RDY;798
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70677-0110-11 in 1 CARTON07/27/202004/30/2023
    118 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20836907/27/2020
    Labeler - Strategic Sourcing Services, LLC (116956644)
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