Label: DOMETUSS-DMX- guaifenesin, dextromethorphan hbr, phenylephrine hcl liquid

  • NDC Code(s): 53809-203-01, 53809-203-04, 53809-203-16
  • 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 teaspoonful) contains

    Guaifenesin 200mg

    Dextromethorphan HBr, USP 30 mg

    Phenylephrine HCL, USP 10 mg

  • Purpose

    Expectorant

    Cough suppressant

    Nasal decongestant

  • KEEP THIS AND ALL DRUGS OUT OF THE 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 drain bronchial tubes
    • Temporarily relieves these symptoms occuring with a cold: nasal congestion, cough due to minor throat and bronchial irritation
  • 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

    • Heart Disease
    • High Blood Pressure
    • Thyroid Disease
    • Diabetes
    • Trouble urinating due to an enlarged prostate gland
    • Cough that occurs with too much phlegm (mucus)
    • Cough that lasts or is chronic such as bronchitis or emphysema
  • If pregnant or breast-feeding

    as a health professional before use.

  • Stop use and ask a doctor if

    • You get nervous, dizzy, or sleepless
    • Symptoms do not get better within 7 days or are accompanied by a fever
    • cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistant headache.

    These could be signs of a serious condition.

  • Directions

      Do not exceed recommended dosage

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

     

     
     age dose
     Adults and children 12 years of age and older 1 teaspoon every 6 hours
     Children under 12 years of age ask a doctor

     

  • Inactive ingredients

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

  • Other information

    • Store at 15°-30° C (59°-86°F)

  • Questions or comments?

    Please call (787) 767-3246

  • DOMETUSS-DMX product label

    NDC 53809-203-01

    DOMETUSS-DMX

    COUGH SUPPRESSANT/EXPECTORANT/NASAL DECONGESTANT

    Alcohol and Sugar

    FREE

    Grape Flavor

    1 Fl. Oz. (30 mL)

    Rev: 12/12

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

    LOT#:/EXP.DATE:

    Manufactured for:

    DOMEL

    SAN JUAN, PUERTO RICO 00924

    Domel Dometuss 203

    Domel Dometuss 203

  • INGREDIENTS AND APPEARANCE
    DOMETUSS-DMX 
    guaifenesin, dextromethorphan hbr, phenylephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53809-203
    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
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE10 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:53809-203-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product01/21/2016
    2NDC:53809-203-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product01/21/2016
    3NDC:53809-203-16473 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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