Label: DOMETUSS-DM- guaifenesin, dextromethorphan hbr liquid

  • NDC Code(s): 53809-201-01, 53809-201-04
  • Packager: Domel Laboratories
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 5, 2024

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  • Drug FactsActive ingredients (in each 5 mL tsp)

    Guaifenesin 200mg

    Dextromethorphan HBr 30 mg

  • Purpose

    Expectorant

    Cough suppressant

  • Keep out of reach of children.

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

  • Uses

    • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
    • temporarily relieves coughs due to minor throat and bronchial irritation as may occur with a cold.
  • Warnings

    • Do not exceed recommended dosage.
    • A persistant cough may be a sign of a serious condition; if cough persists for more than one week, tend to recur, or is accompanied by fever, rash, or persistant headache, consult a doctor.
  • Do not use this product

    • for persistant or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus), unless directed by a doctor
    • If you are now taking a prescription Monoaminooxidase Inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions or Parkinson's disease), or for two weeks after stopping the MAOI drug; if you do not know if you are taking a prescription drug that contains an MAOI, ask a doctor or pharmacist before taking this product.
  • If pregnant or breast-feeding

    as a health professional before use.

  • Directions

    Do not exceed more than 4 doses in any 24- hour period, or as directed by a physician.

     

     
     Adults and children 12 years of age and over Take 1 teaspoonful (5 mL) every 6 hours
     Children 6 to under 12 years of age Take 1/2 teaspoonful (2.5 mL) every 6 hours
     Children under 6 years of age Ask a doctor

     

  • Other Information

    • store at room temperature 15°-30°C (59°-86°F).

    Tamper Evident: Do not use if there is evidence of tampering.

  • Inactive ingredients

    Artificial grape flavor, citric acid, D&C red #33, FD&C blue #1, glycerin, methyl paraben (as preserative), propylene glycol, propyl paraben (as preseratie, purified water, sodium citrate, sucralose.

  • Questions or comments?

    Please call (787) 767-3246

  • DOMETUSS-DM product label

    NDC 53809-201-01

    DOMETUSS-DM

    EXPECTORANT/COUGH SUPPRESSANT

    Alcohol and Sugar

    FREE

    Grape Flavoe

    1 Fl. Oz.

    Rev: 10/13

    Lot#:/EXP.DATE:

    Manufactured for:

    DOMEL

    SAN JUAN, PUERTO RICO 00924

    Domel Dometuss 201

  • INGREDIENTS AND APPEARANCE
    DOMETUSS-DM 
    guaifenesin, dextromethorphan hbr liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53809-201
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 5 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorgrapeImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53809-201-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product01/21/2016
    2NDC:53809-201-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product01/21/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01201/21/2016
    Labeler - Domel Laboratories (808198837)
    Registrant - Domel Laboratories (808198837)
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