Label: ROBITUSSIN DIRECT CHEST CONGESTION- guaifenesin tablet, coated

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

Drug Label Information

Updated November 3, 2023

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  • 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 Product07/15/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01207/15/2022
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
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