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

  • Category: HUMAN OTC DRUG LABEL

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 29, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each tablet)Purpose
    Dextromethorphan HBr20 mgCough Suppressant
    Chlorpheniramine Maleate4 mgAntihistamine
    Phenylephrine HCl10 mgNasal decongestant
  • Uses

    • Temporarily relieves
      • runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever.
      • Nasal congestion due to the common cold.
      • coughs due to minor throat and bronchial irritation as may occur with a cold.
  • Warnings

    • Do not exceed recommended dosage

    Do not use

    • if you are now taken 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.

    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 problem 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.

    Stop using this product and ask a doctor if

    • you get nervous, dizzy or sleepless
    • cough lasts more than 7 days, comes back or is accompanied by fever, rash or persistent headaches, these could be signs of a serious condition.

    When using this product

    • Excitability may occur, especially in children
    • May cause drowsiness
    • alcohol, sedatives and tranquilizers may increase the drowsiness effect
    • Avoid alcoholic beverages while taking this product
    • Use caution when driving motor vehicle or operating machinery.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults even if you do not notice signs or symptoms.

    If you are pregnant or breast-feeding, ask a health professional before use.

  • Directions

    Do not take more than 6 tablets in 24 hours, or as directed by a doctor.

    AgeDose
    adults and children 12 years of age and over1 tablet every 4 hours.
    children under 12 years of ageConsult a doctor before use.
  • 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

    Carbomer, Dicalcium Phosphate, Magnesium Stearate, Microcrystalline Cellulose, Silicon Dioxide, Talc.

  • Questions or comments?

    Please call (787) 767-3246

  • PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

    NDC 53809-240-01

    DOMETUSS-NR

    DEXTROMETHORPHAN HBr/ CHLORPHENIRAMINE
    MALEATE/ PHENILEPHRINE HCl

    • Cough Suppressant
    • Antihistamine
    • Nasal decongestant

    100 TABLETS

    PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label
  • INGREDIENTS AND APPEARANCE
    DOMETUSS-NR 
    dextromethorphan hydrobromide, chlorpheniramine maleate, and phenylephrine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53809-240
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorWHITEScore2 pieces
    ShapeROUNDSize13mm
    FlavorImprint Code KL
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53809-240-01100 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)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lex Inc046172888MANUFACTURE(53809-240)
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