Label: COUGH RELIEF- dextromethorphan hbr capsule, liquid filled

  • NDC Code(s): 33992-0666-5
  • Packager: ASSURED / DOLLAR TREE (Greenbrier International, Inc.)
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 October 7, 2021

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  • 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

    • cough that occurs with too much phlegm (mucus)
    • a cough that lasts or is chronic such 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 headache that lasts. These could be signs of a serious condition.

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep this and all drugs out of the reach of children.

    In case of overdose, seek 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 over: take 2 softgels every 6 to 8 hours, as needed
    • children under 12 years of age: do not use
  • Other information

    • store between 20-25ºC (68-77ºF)
    • avoid excessive heat above 40ºC (104ºF); protect from light
  • Inactive ingredients

    FD&C red 40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide

  • Questions or comments?

    Call 1-877-753-33935 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    COMPARE TO ACTIVE INGREDIENT OF ROBITUSSIN® LONG-ACTING COUGHGELS®*

    ADULT LONG LASTING

    Cough Relief

    • Dextromethorphan HBr, 15 mg

    Cough Suppressant

    Relieves cough for up to 8 hours, Non-Drowsy

    AGES 12+

    Softgels

    This product is not manufactured or distributed by Pfizer Consumer Healthcare, Distributor of Robitussin® Long-Acting CoughGels®.

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

    DISTRIBUTED BY

    GREENBRIER INTERNATIONAL, INC.

    500 VOLVO PARKWAY, CHESAPEAKE, VA 23320

  • Package Label

    Dextromethorphan HBr, USP 15 mg

    ASSURED Cough Relief Softgels

  • INGREDIENTS AND APPEARANCE
    COUGH RELIEF 
    dextromethorphan hbr capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-0666
    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)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorredScoreno score
    ShapeOVALSize12mm
    FlavorImprint Code 404
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:33992-0666-51 in 1 BOX06/30/201712/31/2023
    115 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/30/201712/31/2023
    Labeler - ASSURED / DOLLAR TREE (Greenbrier International, Inc.) (610322518)
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