Label: COUGH RELIEF 15 MG- dextromethorphan hbr capsule, liquid filled

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated January 3, 2024

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  • Active ingredient(in each capsule)

    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

    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 capsules 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 capsults 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

  • Inactive ingredients

    FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol 400, propylene glycol, povidone, purified water, sorbitol 70% solution, sorbitol sorbitan solution, titanium dioxide.

  • Questions?

    call 1-844-735-0202

  • PRINCIPAL DISPLAY PANEL

    01b LBL (PDP)_Cough Relief_Dex HB5 15mg_150ct

    01b LBL (DF1)_Cough Relief_Dex HB5 15mg

    01b LBL (DF2)_Cough Relief_Dex HB5 15mg

  • INGREDIENTS AND APPEARANCE
    COUGH RELIEF  15 MG
    dextromethorphan hbr capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81179-015
    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)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POVIDONE (UNII: FZ989GH94E)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL SOLUTION 70% (UNII: 8KW3E207O2)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorredScoreno score
    ShapeOVALSize13mm
    FlavorImprint Code IS3
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81179-015-00150 in 1 BOTTLE; Type 0: Not a Combination Product05/05/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01205/05/2021
    Labeler - YET HEALTH GROUP LLC (117763296)
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