Label: COUGH RELIEF- dextromethorphan hydrobromide capsule, liquid filled

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 1, 2025

If you are a consumer or patient please visit this version.

View All Sections
  • Drug Facts

  • Active Ingredient (in each tablet)

    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 useif 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 (1-800-222-1222) 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 older take 2 softgels every 6 to 8 hours, as needed
     children under 12 years do not use

  • Other information

    • store between  20° and 25°C (68°–77°F)

    • avoid excessive heat above 40°C (104°F)

    • protect from light

    • DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED

  • Inactive ingredients

    Edible Ink, FD&C Red No. 40, Gelatin, Glycerin, Polyethylene Glycol 400, POLYSORB, Propylene Glycol, Purified Water, Povidone K30.

  • Questions?

    Call  1-800-630-8895

  • Distributed by: 

    Advanced Rx LLC

    1942 NE 163rd St

    North Miami Beach,

    FL 33162 U.S.A.

  • PRINCIPAL DISPLAY PANEL

    NDC 80513-311-06

    Cough Relief

    LABEL

  • INGREDIENTS AND APPEARANCE
    COUGH RELIEF 
    dextromethorphan hydrobromide capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80513-311
    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 K30 (UNII: U725QWY32X)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorredScoreno score
    ShapeOVALSize13mm
    FlavorImprint Code 904
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80513-311-0660 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01201/01/2025
    Labeler - Advanced Rx LLC (042795108)
    Establishment
    NameAddressID/FEIBusiness Operations
    ELYSIUM PHARMACEUTICALS LIMITED915664486manufacture(80513-311)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!