Label: ROBITUSSIN DIRECT CHEST CONGESTION- guaifenesin tablet, coated

  • NDC Code(s): 0031-9303-01
  • Packager: Haleon US Holdings LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 12, 2024

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

View All Sections
  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)

    Guaifenesin 400 mg

  • PURPOSE

    Purpose

    Expectorant

  • INDICATIONS & USAGE

    Use

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

  • WARNINGS

    Warnings

    Ask a doctor before use if you have

    •
    cough accompanied by too much phlegm (mucus)
    •
    persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

    Stop use and ask a doctor if

    cough persists more than 7 days, tends to recur, or is accompanied by a fever, rash, or persistent headache.

    These could be signs of a serious condition.

    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.

  • DOSAGE & ADMINISTRATION

    Directions

    •
    take with a full glass of water
    •
    do not take more than 6 tablets in 24 hours
    •
    do not take more than directed

    adults and children 12 years and over

    take 1 tablet every 4 hours

    children under 12 years

    Do not use
  • STORAGE AND HANDLING

    Other information

    •
    store at 20°-25°C (68°-77°F)
  • INACTIVE INGREDIENT

    Inactive ingredients

    FD&C blue no. 1 aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, sodium starch glycolate, stearic acid

  • QUESTIONS

    Questions or comments?

    Call weekdays from 9 AM-5 PM EST at 1-800-245-1040

  • Additional Information

    Do not use if safety seal under cap printed with “Sealed for Your Protection” is broken or missing.

    Lift Here for More Drug Facts

    Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

    visit www.robitussin.com

    Trademarks owned or licensed by GSK.

    ©2022 GSK or licensor.

    Made in China

  • PRINCIPAL DISPLAY PANEL

    NEW

    Robitussin

    Chest Congestion

    Guaifenesin
    (Expectorant)

    direct

    Actual size

    18
    Tablets
    L-0630-532-44-UPC_ORG Front Label

    Robitussin Direct Chest Congestion 18 tablets
  • INGREDIENTS AND APPEARANCE
    ROBITUSSIN DIRECT CHEST CONGESTION 
    guaifenesin tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-9303
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorBLUEScore2 pieces
    ShapeROUNDSize13mm
    FlavorImprint Code 44;532
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0031-9303-0118 in 1 BOTTLE; Type 0: Not a Combination Product07/15/202202/15/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01207/15/202202/15/2025
    Labeler - Haleon US Holdings LLC (079944263)
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!