Label: COUGH MEDICINE SOOTHING RELIEF- dextromethorphan liquid

  • NDC Code(s): 75663-002-01, 75663-002-10
  • Packager: LM WHOLESALE HERBS
  • 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 May 29, 2020

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

  • Active ingredient (in each 10 ml)

    Dextromethorphan Hydrobromide 30 mg

  • 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

    ■ cough that occurs with too much phlegm (mucus)

    ■ cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

  • Stop use and ask a doctor if

    cough lasts 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

  • Keep out of reach of children

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    ■ do not take more than 4 doses in any 24-hour period

    ■ one dose is one bottle

    ■ this adult product is not intended for use in children under 12 years of age

    AgeDose

    Adults and Children one bottle (10 ml)

    12 years and over every 6-8 hours

    Children under 12 years do not use

  • Inactive Ingredients

    Apricot kernel oil, fritillaria delavayi bulb, honey, water

  • Other information

    ■ Store at 20C-25ºC (68F-77º F). Do not refrigerate

  • Questions or comments?

    ■ 1-800-860-0888

  • Package Label

    package label

  • INGREDIENTS AND APPEARANCE
    COUGH MEDICINE  SOOTHING RELIEF
    dextromethorphan liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75663-002
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    APRICOT KERNEL OIL (UNII: 54JB35T06A)  
    HONEY (UNII: Y9H1V576FH)  
    FRITILLARIA DELAVAYI BULB (UNII: AG6Q756AT7)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorbrown (light brown) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75663-002-016 in 1 BOX05/18/2020
    1NDC:75663-002-1010 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/18/2020
    Labeler - LM WHOLESALE HERBS (104462911)
    Establishment
    NameAddressID/FEIBusiness Operations
    RFX Pharmaceutical Co., Ltd.530620871manufacture(75663-002)