ROBITUSSIN LONG-ACTING COUGHGELS (DEXTROMETHORPHAN HYDROBROMIDE) CAPSULE, LIQUID FILLED [RICHMOND DIVISION OF WYETH]

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  • ROBITUSSIN LONG-ACTING COUGHGELS (DEXTROMETHORPHAN HYDROBROMIDE) CAPSULE, LIQUID FILLED [RICHMOND DIVISION OF WYETH]

ROBITUSSIN LONG-ACTING COUGHGELS (DEXTROMETHORPHAN HYDROBROMIDE) CAPSULE, LIQUID FILLED [RICHMOND DIVISION OF WYETH]
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NDC 0031-8743-20
Set ID 472c5c1f-eb5a-444b-a17e-f0d71007fb15
Category HUMAN OTC DRUG LABEL
Packager GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Generic Name
Product Class
Product Number
Application Number PART341
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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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