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
  • 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 December 15, 2022

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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 finalpart34101/21/2016
    Labeler - Domel Laboratories (808198837)
    Registrant - Domel Laboratories (808198837)
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