Label: GUAIFENESIN tablet, extended release

  • NDC Code(s): 68001-561-16, 68001-561-17
  • Packager: BluePoint Laboratories
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 12, 2023

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  • Active ingredient

    (in each extended-release tablet)

    Guaifenesin USP 600 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 or 2 tablets every 12 hours. Do not exceed 4 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)
  • 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.

    Manufactured by:

    APL Healthcare Limited Unit-IV.

    Tirupati (Dt) - 524421, India

    For BluePoint Laboratories

    Made in India

    Code: AP/DRUGS/04/2016

    Rev: 10/2022

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg Blister Foil and 600 mg Carton (80 Extended-Release Tablets, 1x10's).


    Blister Pack : NDC 68001-561-16

    Blister pack

    Carton Pack : NDC 68001-561-17


    Guaifenesin Extended-Release Tablets 600 mg


    EXPECTORANT

    12 HOUR

    • Relieves Chest Congestion
    • Thins And Loosens Mucus

    80 Extended-Release Tablets

    Carton

  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN 
    guaifenesin tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68001-561
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN600 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
    ShapeOVALSize16mm
    FlavorImprint Code L;68
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68001-561-178 in 1 CARTON03/15/2023
    1NDC:68001-561-1610 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21045303/15/2023
    Labeler - BluePoint Laboratories (985523874)
    Establishment
    NameAddressID/FEIBusiness Operations
    APL HEALTHCARE LIMITED650918514analysis(68001-561) , manufacture(68001-561)
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