Label: GUAIFENESIN tablet, extended release

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

Drug Label Information

Updated December 1, 2023

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  • Active ingredient

    (in each extended-release tablet)
    Guaifenesin USP 1200 mg

  • Purpose

    Expectorant

  • Uses


    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • Warnings


    Do not use

    • for children under 12 years of age
  • Ask a doctor before use if you have


    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
    • cough accompanied by too much phlegm (mucus)
  • Stop use and ask a doctor if


    • cough lasts more than 7 days, comes back, or occurs with 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 the timing of meals
    • adults and children 12 years of age and over: 1 tablet every 12 hours. Do not exceed 2 tablets in 24 hours.
    • children under 12 years of age: do not use
  • Other information

    • store between 20° to 25°C (68° to 77°F)
    • Tamper evident: Do not use if carton is open or if seal on blister is broken or missing
  • Inactive ingredients


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

  • Questions?

    1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST) You may also report side effects to this phone number.


    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 - 1200 mg Blister Carton (42 (3 x 14) Tablets)

    NDC 58602-865-03
    PrimaryHealth

    COMPARE TO Maximum
    Strength Mucinex®
    Active Ingredient*

    MAXIMUM STRENGTH

    Guaifenesin
    Extended-Release Tablets
    1200 mg
    EXPECTORANT

    • Relieves Chest Congestion
    • Thins And Loosens Mucus

    12
    HOUR

    42
    Extended-Release
    Tablets

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg Blister Carton (42 (3 x 14) Tablets)

  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN 
    guaifenesin tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-865
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN1200 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSE 2208 (15000 MPA.S) (UNII: Z78RG6M2N2)  
    HYPROMELLOSE 2910 (10000 MPA.S) (UNII: 0HO1H52958)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)  
    MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)  
    POVIDONE K90 (UNII: RDH86HJV5Z)  
    POVIDONE K25 (UNII: K0KQV10C35)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorWHITE (white to off-white) Scoreno score
    ShapeOVALSize21mm
    FlavorImprint Code L;69
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58602-865-033 in 1 CARTON03/11/2021
    114 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21045303/11/2021
    Labeler - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    APL HEALTHCARE LIMITED650918514ANALYSIS(58602-865) , MANUFACTURE(58602-865)
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