Label: ROBITUSSIN LONG-ACTING COUGHGELS- dextromethorphan hydrobromide capsule, liquid filled

  • NDC Code(s): 0031-8743-20
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated November 2, 2020

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  • ACTIVE INGREDIENT

    Active ingredient (in each liquid-filled capsule)

    Dextromethorphan HBr, USP 15 mg

  • PURPOSE

    Purpose

    Cough suppressant

  • INDICATIONS & USAGE

    Use

    temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.

  • 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

    •
    a cough that occurs with too much phlegm (mucus)
    •
    a cough that lasts or is chronic as occurs with smoking, asthma, or emphysema

    Stop use and ask a doctor if cough lasts for more than 7 days, comes back, or is accompanied by 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

    •
    do not take more than 8 capsules in any 24-hour period
    •
    this adult product is not intended for use in children under 12 years of age
    agedose

    adults and children 12 years and over

    take 2 capsules every 6 to 8 hours, as needed

    children under 12 years

    do not use
  • STORAGE AND HANDLING

    Other information

    •
    store at 20-25°C (68-77°F)
    •
    avoid excessive heat above 40°C (104°F)
    •
    protect from light
  • INACTIVE INGREDIENT

    Inactive ingredients

    FD&C blue no. 1, FD&C red no. 40, fractionated coconut oil, gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol, povidone, propyl gallate, propylene glycol, purified water, sorbitol, sorbitol anhydrides

  • QUESTIONS

    Questions or comments?

    Call weekdays from 9 AM-5 PM EST at 1-800-762-4675

  • SPL UNCLASSIFIED SECTION

    Distributed by: Pfizer, Madison, NJ 07940 USA

  • PRINCIPAL DISPLAY PANEL

    ADULT
    NEW LOOK!

    Robitussin®

    Long-Acting
    CoughGels®

    DEXTROMETHORPHAN HBr
    (Cough Suppressant)

    UP
    TO
    8 HR
    RELIEF

    Non-Drowsy
    Formula

    For Ages 12 & Over

    20
    LIQUI-GELS®*
    *LIQUID FILLED CAPSULES

    Robitussin LA CoughGels 20 Liqui-Gels
  • INGREDIENTS AND APPEARANCE
    ROBITUSSIN LONG-ACTING COUGHGELS 
    dextromethorphan hydrobromide capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-8743
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MANNITOL (UNII: 3OWL53L36A)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorREDScoreno score
    ShapeOVALSize10mm
    FlavorImprint Code R
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0031-8743-201 in 1 CARTON01/04/2019
    120 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34101/04/2019
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
    Establishment
    NameAddressID/FEIBusiness Operations
    PF Consumer Healthcare Canada ULC203812479ANALYSIS(0031-8743) , LABEL(0031-8743) , PACK(0031-8743)
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