Label: GUAIFENESIN tablet, extended release

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

Drug Label Information

Updated July 1, 2025

If you are a consumer or patient please visit this version.

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

    Guaifenesin  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  (1-800-222-1222) right away.

  • 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 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 20-25°C (68-77°F).
    • DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED.
  • Inactive ingredients

    carbomer homopolymer type B, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate.

  • Questions?

    call toll-free 1-800-630-8895

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN 
    guaifenesin tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80513-413
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN1200 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize21mm
    FlavorImprint Code G;1200
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80513-413-11110 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21342012/18/2020
    Labeler - Advanced Rx LLC (042795108)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ganules India Limited918609236manufacture(80513-413)
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, PubMed, Biochemical Data Summary

More Info on this Drug

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