Label: ROBITUSSIN DIRECT STUFFY NOSE- phenylephrine hcl tablet, coated

  • NDC Code(s): 0031-9305-01
  • 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)

    Phenylephrine HCl 10 mg

  • PURPOSE

    Purpose

    Nasal decongestant

  • INDICATIONS & USAGE

    Uses

    •
    temporarily relieves sinus congestion and pressure
    •
    temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • WARNINGS

    Warnings

    Do not use

    if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist

    before taking this product.

    Ask a doctor before use if you have

    •
    heart disease
    •
    high blood pressure
    •
    thyroid disease
    •
    diabetes
    •
    trouble urinating due to an enlarged prostate gland

    When using this product do not use more than directed.

    Stop Use and ask a doctor if

    •
    nervousness, dizziness, or sleeplessness occur
    •
    symptoms do not improve within 7 days or occur with fever

    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

    •
    do not take more than 6 tablets in 24 hours
    •
    this adult product is not intended for use in children under 12 years of age

    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

    carboxymethylcellulose sodium, croscarmellose sodium, dextrose monohydrate, dibasic calcium

    phosphate dihydrate, FD&C red no. 40, magnesium stearate, maltodextrin, microcrystalline cellulose, silicon dioxide, sodium citrate, soy lecithin, titanium dioxide

  • QUESTIONS

    Questions or comments?

    Call weekdays from 9 AM to 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

    Stuffy Nose
    Phenylephrine HCl

    (Nasal Decongestant)

    direct

    Actual size

    18
    Tablets
    L-0630-453-44-UPC_ORG Front Label

    Robitussin Direct Stuffy Nose 18 caplets
  • INGREDIENTS AND APPEARANCE
    ROBITUSSIN DIRECT STUFFY NOSE 
    phenylephrine hcl tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-9305
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorREDScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code 44;453
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0031-9305-0118 in 1 BOTTLE; Type 0: Not a Combination Product07/15/202210/15/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01207/15/202210/15/2024
    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!