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

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ROBITUSSIN LINGERING COLD LONG-ACTING COUGHGELS (DEXTROMETHORPHAN HBR) CAPSULE, LIQUID FILLED [RICHMOND DIVISION OF WYETH]
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NDC 0031-8741-20
Set ID a19d233a-bc41-4603-dcbc-e15088045c2d
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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  • DRUG FACTS

  • ACTIVE INGREDIENT (IN EACH LIQUID-FILLED CAPSULE)

    Dextromethorphan HBr, USP 15 mg

  • PURPOSE

    Cough suppressant

  • USE

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

  • 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 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.

  • 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
  • OTHER INFORMATION

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

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

  • PRODUCT PACKAGING

    The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

    ADULT

    Robitussin LINGERING COLD Long-Acting CoughGels

    DEXTROMETHORPHAN HBr (Cough Suppressant)

    Relieves: Cough for up to 8 Hours

    Non-Narcotic Formula

    Non-Drowsy

    For Ages 12 & Over

    20 LIQUI-GELS*

    *Liquid-Filled Capsules

    PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.org

    Stop use and ask a doctor if cough lasts more than 7 days.

    Pfizer, Madison, NJ 07940 USA © 2011 Pfizer Inc.

    For most recent product information, visit www.robitussin.com

    LIQUI-GELS is a trademark or registered trademark of Catalent Pharma Solutions.

    Robitussin Lingering Cold Long-Acting CoughGels Packaging
  • INGREDIENTS AND APPEARANCE
    ROBITUSSIN LINGERING COLD LONG-ACTING COUGHGELS 
    dextromethorphan hbr capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-8741
    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 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
    ColorRED (clear red) Scoreno score
    ShapeOVAL (oval softgel) Size10mm
    FlavorImprint Code R
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0031-8741-201 in 1 BLISTER PACK06/06/201106/01/2022
    120 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/06/201106/01/2022
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
    Establishment
    NameAddressID/FEIBusiness Operations
    PF Consumer Healthcare Canada ULC203812479ANALYSIS(0031-8741) , LABEL(0031-8741) , PACK(0031-8741)
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