Label: COUGH RELIEF- dextromethorphan hydrobromide capsule, liquid filled

  • NDC Code(s): 68210-4181-3
  • Packager: Spirit Pharmaceuticals LLC
  • Category: HUMAN OTC DRUG LABEL

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 December 5, 2022

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  • Drug Facts

  • Active Ingredient (in each tablet)

    Dextromethorphan HBr 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 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. (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 & children 12 years & over take 2 softgels every 6 to 8 hours, as needed
     children under 12 years of age 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 Red No. 40, gelatin, glycerin, polyethylene glycol 400, propylene glycol, povidone,sorbitol sorbitan solution, titanium dioxide

  • Questions or comments?

    1-888-333-9792

  • Distributed by: 

    Cabinet Health P.B.C.

  • Display Panel

    PACKAGE NOT CHILD-RESISTANT

    CABINET

    Cough Relief

    Active ingredient: DEXTROMETHORPHAN HBr 15 MG

    Cough Suppressant

    Relieves Cough up to 8 Hours

    Non-Drowsy

    Non-Narcotic

    CABINET: The Sustainable Healthcare Co.™

    Cough Relief Pouch

  • INGREDIENTS AND APPEARANCE
    COUGH RELIEF 
    dextromethorphan hydrobromide capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-4181
    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 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POVIDONE (UNII: FZ989GH94E)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorredScoreno score
    ShapeCAPSULESize13mm
    FlavorImprint Code 904
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68210-4181-330 in 1 POUCH; Type 0: Not a Combination Product11/17/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34111/17/2021
    Labeler - Spirit Pharmaceuticals LLC (179621011)
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