Label: GUAIFENESIN tablet, extended release

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 18, 2023

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

View All Sections
  • Active ingredients (in each extended-release bi-layer tablet)

    Guaifenesin 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

  • 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 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 breat-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 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 carton is open or if printed seal on blister is broken or missing.
    ■ store between 20-25°C (68-77°F)

  • Inactive ingredients

    carbomer homopolymer type B; hypromellos, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

  • Questions?

    Contact 1-877-770-3183
    Mon-Fri 8:00 AM EST to 5:00 PM PST.

  • PDP

    20ct

  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN 
    guaifenesin tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69848-017
    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 TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)  
    HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize16mm
    FlavorImprint Code G;600
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69848-017-0220 in 1 BLISTER PACK; Type 0: Not a Combination Product01/06/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21342012/31/2021
    Labeler - GRANULES USA, INC. (137098864)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!