Label: DOMETUSS-DA- chlorpheniramine maleate, phenylephrine hydrochloride liquid

  • 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 tsp)

    Chlorpheniramine Maleate 1 mg

    Phenylphrine HCL 2.5 mg

  • Purpose

    Antihistamine

    Nasal Decongestant

  • Keep out of reach of children.

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

  • Uses

    • Temporarily relieves runny nose and sneezing
    • itching of the nose or throat and itchy
    • watery eyes due to hay fever or other respiratory allergies (allergic rhinitis)
    • temporarily relieves nasal congestion due to common cold
    • temporarily restores freer breathing through the nose
  • 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-DA product label

    NDC 53809-206-04

    DOMETUSS-DA

    NASAL DECONGESTANT & ANTIHISTAMINIC

    • Itchy, Waterl Eyes
    • Runny Nose
    • Stuffy Nose
    • Sneezing

    bubble gum flavor

    4 fl. oz. (118 mL)

    Rev: 05/13

    Lot #

    Exp:

    Manufactured for:

    DOMEL

    SAN JUAN, PUERTO RICO 00924

    Domel Dometuss 206

  • INGREDIENTS AND APPEARANCE
    DOMETUSS-DA 
    chlorpheniramine maleate, phenylephrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53809-206
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE1 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE2.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)  
    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
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53809-206-04118 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 finalpart34101/21/2016
    Labeler - Domel Laboratories (808198837)
    Registrant - Domel Laboratories (808198837)
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