Label: GUAIFENESIN AND PSEUDOEPHEDRINE HCL tablet, extended release

  • NDC Code(s): 58602-833-12, 58602-833-17
  • Packager: Aurohealth LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated September 3, 2024

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  • Active ingredients

    (in each extended-release tablet)     

    Guaifenesin USP 600 mg                                                                                      

    Pseudoephedrine HCl USP 60 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 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
    • adults and children 12 years and older: 2 extended-release tablets every 12 hours; not more than 4 extended-release tablets in 24 hours
    • children under 12 years of age: do not use
  • Other information

    • store at 20 to 25°C (68 to 77°F)
  • Inactive ingredients

    colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinised starch (maize).

  • Questions?

    1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)

    Distributed by:
    AUROHEALTH LLC
    279 Princeton-Hightstown Road
    East Windsor, NJ 08520

    Made in India
    Code: AP/DRUGS/04/2016

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg/60 mg (18 Tablet Carton Label)

    AUROHEALTH

    NDC 58602-833-12
    *Compare to the active
    ingredients of Mucinex®D

    Guaifenesin and
    Pseudoephedrine Hydrochloride
    Extended-Release Tablets
    600 mg/60 mg

    Guaifenesin 600 mg - Expectorant
    Pseudoephedrine HCl 60 mg - Nasal Decongestant
    RELIEVES NASAL & CHEST CONGESTION

    12 HOUR
    • Clears Nasal & Sinus Congestion
    • Thins & Loosens Mucus

    18 Extended-Release Tablets

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg/60 mg (18 Tablet Carton Label)

  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN AND PSEUDOEPHEDRINE HCL 
    guaifenesin and pseudoephedrine hcl tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-833
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSE 2208 (15000 MPA.S) (UNII: Z78RG6M2N2)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)  
    MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)  
    POVIDONE K25 (UNII: K0KQV10C35)  
    POVIDONE K90 (UNII: RDH86HJV5Z)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorWHITE (white to off-white) Scoreno score
    ShapeOVAL (biconvex) Size14mm
    FlavorImprint Code 64;X
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58602-833-121 in 1 CARTON03/25/2020
    118 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:58602-833-172 in 1 CARTON03/25/2020
    218 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21320303/25/2020
    Labeler - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    APL HEALTHCARE LIMITED650918514ANALYSIS(58602-833) , MANUFACTURE(58602-833)
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