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

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated August 30, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts:

  • ACTIVE INGREDIENT

    Active Ingredients (in each 5ml-teaspoonful)Purpose
    Chlorpheniramine Maleate 2mgAntihistamine
    Dextromethorphan HBr 10mgCough Suppresant
    Phenylephrine HCl 5mgNasal 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 days, comes back, or is accompanied by fever, rash or persitent 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 over2 teaspoonful ( 10 ml ) every 4 hours.
    Children 6 to under 12 years of age1 teaspoonful ( 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, flavor, methylparaben, propylparaben, propylene glycol, purified water, sodium citrate and sucralose.

  • Questions or comments?

    Please call (787) 767-3246.

  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

    NDC 53809-222-04

    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 liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53809-222
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg  in 118 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 118 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 118 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53809-222-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product03/06/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM01203/06/2024
    Labeler - Domel Laboratories (808198837)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dextrum Laboratories007392322MANUFACTURE(53809-222)
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