Label: DEXTROMETHORPHAN HYDROBROMIDE capsule, liquid filled

  • NDC Code(s): 68210-0106-1, 68210-0106-2
  • Packager: Spirit Pharmaceuticals LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 7, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each softgel)

    Dextromethorphan HBr, USP 15mg

  • 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 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 orcontact a Poison Control Center right away.

  • 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 capsules every 6 to 8 hours, as needed
    children under 12 yearsdo 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 red no. 40, gelatin, glycerin, polyethylene glycol 400, propylene glycol, povidone, sorbitol sorbitan, titanium dioxide

  • Questions or comments?

    1-888-333-9792

  • SPL UNCLASSIFIED SECTION

    Distributed By: 

    SPIRIT PHARMACEUTICALS LLC.

    RONKONKOMA, NY 11779

  • PRINCIPAL DISPLAY PANEL

    Compare to the Active Ingredient of
    ROBITUSSIN ® LONG ACTING COUGH GELS ©*

    VALUMEDS™

    ADULT LONG-LASTING
    Cough Relief FOR AGES 12 & OVER

    Dextromethorphan HBr, 15 mg

    Cough suppressant

    Relieves cough for up to 8 hours

    image description

    image description

  • INGREDIENTS AND APPEARANCE
    DEXTROMETHORPHAN HYDROBROMIDE 
    dextromethorphan hydrobromide capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-0106
    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
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POVIDONE K30 (UNII: U725QWY32X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GELATIN (UNII: 2G86QN327L)  
    SORBITOL (UNII: 506T60A25R)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorredScoreno score
    ShapeOVALSize13mm
    FlavorImprint Code 404
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68210-0106-11 in 1 CARTON04/10/2018
    115 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:68210-0106-21 in 1 CARTON03/12/2020
    2240 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01204/10/2018
    Labeler - Spirit Pharmaceuticals LLC (179621011)
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