Label: MUCUS RELIEF- guaifenesin tablet, extended release

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated May 3, 2021

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT(in each extended-release tablet)

    Guaifenesin 600 mg

  • PURPOSE

    Expectorant

  • USE(S)

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

  • WARNING

    .

  • 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

    • tamper evident: do not use if seal on the bottle printed "SEALED for YOU PROTECTION" is broken or missing. 
    • store between 20 to 25°C (68 to 77°F)
  • INACTIVE INGREDIENTS

    carbomer homopolymer, hypromellose, microcrystalline cellulose, povidone

  • QUESTIONS?

    1-800-616-2471

    You may also report side effects to this phone number. 

  • Repackaging Information

    Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

    Count600 mg
    1271610-499-12
    6071610-499-53

    Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

    Repackaged by:
    Aphena Pharma Solutions - TN
    Cookeville, TN 38506

    20201217JH

  • PRINCIPAL DISPLAY PANEL - 600 mg

    NDC 71610-499 - Guaifenesin ER 600 mg Tablets
    Bottle Label 600 mg

  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF 
    guaifenesin tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71610-499(NDC:0904-6986)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN600 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeCAPSULESize22mm
    FlavorImprint Code G233
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71610-499-1212 in 1 BOTTLE; Type 0: Not a Combination Product04/16/2021
    2NDC:71610-499-5360 in 1 BOTTLE; Type 0: Not a Combination Product11/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20921509/23/2019
    Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aphena Pharma Solutions - Tennessee, LLC128385585REPACK(71610-499)