Label: ADULT LONG LASTING COUGH RELIEF- dextromethorphan hbr capsule, liquid filled

  • NDC Code(s): 83059-0027-1
  • Packager: Shield Pharmaceuticals Corp
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 8, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each softgel)

    Dextromethorphan HBr, USP 15 mg

  • Purpose

    Cough suppressant

  • Uses

    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 ifcough 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 (1-800-222-1222).

  • Directions

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

    adults and children 12 years and overtake 2 softgels every 6 to 8 hours, as needed
    children under 12 yearsdo not use

  • Other information

    • store at controlled room temperature 20-25ºC (68-77ºF)
    • avoid excessive heat above 40°C (104°F)
    • protect from light

  • Questions or comments?

    1-800-373-6981 (toll-free)

  • Inactive ingredients

    FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow 06, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitan

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Shield Pharmaceuticals Corp.
    Hauppauge, NY 11788

  • PRINCIPAL DISPLAY PANEL

    ValuRx

    Compare to the active ingredient in Robitussin® Long-Acting Coughgels®†

    Up to 8 Hr. Relief

    Adult Long-Lasting
    Cough Relief
    Dextromethorphan HBr
    (Cough Suppressant)

    Cough Relief Carton

  • INGREDIENTS AND APPEARANCE
    ADULT LONG LASTING COUGH RELIEF 
    dextromethorphan hbr capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83059-0027
    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)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITAN (UNII: 6O92ICV9RU)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeCAPSULESize10mm
    FlavorImprint Code SD29
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83059-0027-11 in 1 CARTON04/08/2024
    115 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01204/08/2024
    Labeler - Shield Pharmaceuticals Corp (118724924)
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