Label: DOMETUSS- chlorpheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride syrup

  • 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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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 5 ml-teaspoonful)Purpose
    Chlorpheniramine Maleate 4 mgAntihistamine
    Dextromethorphan HBr 20 mgCough suppressant
    Phenylephrine HCl 10 mgNasal Decongestant
  • USE

    • For temporary relief of runny nose, sneezing,itching of the nose or throat and itchy watery eyes due to hay fever.
    • Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold.
    • Temporarily restores freer breathing through the nose
  • WARNINGS

    DO NOT USE

    • to sedate a child or to make a child sleepy
    • 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
    • thyroid disease
    • trouble urinating due to enlarged prostate gland
    • glaucoma
    • cough that occurs with too much phlegm (mucus)
    • a breathing problems or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis or emphysema

    ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE

    • taking sedatives or tranquilizers

    • When using this product
      DO NOT EXCEED RECOMMENDED DOSAGE
    • may cause marked drowsiness
    • avoid alcoholic beverages
    • Alcohol, sedatives, and tranquilizers may cause increased drowsiness
    • be careful when driving a motor vehicle or operating machinery
    • excitability may occur, especially with children.

    STOP USE AND ASK A DOCTOR IF

    you get nervous, dizzy, or sleepless.

    • cough last more than 7 day, comes back, or is accompanied by fever, rash or persistent headaches. These could be signs of a serious condition.

    IF PREGNANT OR BREAST FEEDING ask a health professional before use.

    KEEP OUT OF REACH OF CHILDREN. in case of accidental overdose, get medical help or contact a poison control Center right away.

  • Directions

    Do not exceed more than 6 doses in any 24-hour period

    Adults and children 12 years of age and overTake 1 teaspoonful (5 mL) every 4 hours
    Children 6 to under 12 years of ageTake 1/2 teaspoonful (2.5 mL) every 4 hours
    Children under 6 years of ageAsk a doctor
  • Other Information

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

  • Tamper-Evident Disclosure

    Do not use this product if aluminum foil over bottle opening is torn, broken or missing.

  • Inactive ingredients

    citric acid,grape flavor,glycerin hydroxyethylcellulose methylparaben,propylen glycol, propylparaben, purified water,sodiumcitrate,and sucralose.

  • Questions or comments?

    Please call (787) 767-3246

  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

    NDC 53809-202-04

    DOMETUSS

    Antihistamine/Cough Suppressant
    /Nasal Decongestant

    Sugar, Alcohol, And Dye
    Free
    Grape Flavor

    4 fl. oz (118 ml)

    PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    DOMETUSS 
    chlorpheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53809-202
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 mg  in 5 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    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
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53809-202-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34108/01/2015
    Labeler - Domel Laboratories (808198837)
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