Label: ROBITUSSIN DIRECT RUNNY NOSE- diphenhydramine tablet, coated

  • NDC Code(s): 0031-9304-01
  • 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)

    Diphenhydramine HCI 25 mg

  • PURPOSE

    Purpose

    Antihistamine

  • INDICATIONS & USAGE

    Uses

    • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • itchy, watery eyes
    • sneezing
    • itching of the nose or throat
    • temporarily relieves these symptoms due to the common cold:
    • runny nose
    • sneezing
  • WARNINGS

    Warnings

    Do not use

    • to make a child sleepy
    • with any other product containing diphenhydramine, even one used on skin

    Ask a doctor before use if you have

    • glaucoma
    • a breathing problem such as emphysema or chronic bronchitis
    • trouble urinating due to an enlarged prostate gland

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers

    When using this product

    • marked drowsiness may occur
    • avoid alcoholic beverages
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • use caution when driving a motor vehicle or operating machinery
    • excitability may occur, especially in children

    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 directed
    • take every 4 to 6 hours, or as directed by a doctor
    • do not take more than 6 times in 24 hours

    adults and children 12 years and over

    1 to 2 tablets

    Children 6 to under 12 years

    1 tablet

    children under 6 years

    do not use
  • STORAGE AND HANDLING

    Other information

    • each tablet contains:calcium 30 mg
    • store at 20-25°C (68-77°F)
  • INACTIVE INGREDIENT

    Inactive ingredients

    D&C red no. 27 aluminum lake, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch,

    silicon dioxide, stearic acid, talc, 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

    Runny Nose
    Diphenhydramine HCl

    (Antihistamine)

    direct

    Actual size

    18
    Tablets
    L-0630-329-44-UPC_ORG Front Label

    Robitussin Direct Runny Nose 18 caplets
  • INGREDIENTS AND APPEARANCE
    ROBITUSSIN DIRECT RUNNY NOSE 
    diphenhydramine tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-9304
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeOVALSize11mm
    FlavorImprint Code 44;329
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0031-9304-0118 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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