Label: 12 HOUR MUCUS RELIEF- guaifenesin tablet, extended release

  • NDC Code(s): 63868-149-20
  • Packager: CHAIN DRUG MARKETING ASSOCIATION INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 10, 2021

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each extended-release 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

  • WARNINGS

    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 20-25ºC (68-77ºF)

    ■ retain carton for complete product information and warnings

  • Inactive ingredients

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

  • PRINCIPAL DISPLAY PANEL

    QUALITY CHOICE®

    NDC 63868-149-20

    †Compare to the Active Ingredient in MUCINEX®

    12 Hour

    Mucus Relief

    Expectorant

    Guaifenesin Extended-Release Tablets, 600 mg

    • Relieves Chest Congestion

    • Thins & Loosens Mucus

    • Immediate and Extended Release

    Actual Size

    20 EXTENDED-RELEASE TABLETS

    image description

  • INGREDIENTS AND APPEARANCE
    12 HOUR MUCUS RELIEF 
    guaifenesin tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-149
    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 (15 MPA.S) (UNII: 36SFW2JZ0W)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize16mm
    FlavorImprint Code G;600
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-149-202 in 1 CARTON09/17/2021
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21342009/17/2021
    Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774)
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!