Label: DELTUSS DMX COUGH SUPPRESSANT NASAL DECONGESTANT ANTIHISTAMINE GRAPE FLAVOR- dexchlorpheniramine maleate, dextromethorphan hydrobromide, pseudoephedrine hydrochloride liquid

  • NDC Code(s): 58238-225-04
  • Packager: Deliz Pharmaceutical Corp
  • 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 January 17, 2020

If you are a consumer or patient please visit this version.

  • Drug Facts


  • Active ingredients(in each 5 mL teaspoonful)

    Dexchlorpheniramine maleate, USP 1 mg
    Dextromethorphan HBr, USP 15 mg
    Pseudoephedrine HCl, USP 30 mg

    Purpose

    Antihistamine

    Cough suppressant

    Nasal Decongestant

  • Uses

    • temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold or inhaled irritants
    • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
    • Temporarily relieves these symptoms due to hay fever (allergic rhinitis):
    • runny nose
    • sneezing
    • itching of the nose or throat
    • itchy, watery eyes
    • Temporarily restores freer breathing through the nose
  • Warnings


    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
    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma
    • difficulty in urination due to enlarged prostrate gland
    • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
    • cough accompanied by excessive phlegm (mucus)

    Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers


    When using this product

    • do not exceed recommended dosage
    • marked drowsiness may occur
    • alcohol, sedatives, and tranquilizers may increase the drowsiness effect
    • avoid alcoholic beverages
    • use caution when driving a motor vehicle or operating machinery
    • excitability may occur especially in children

    Stop use and ask a doctor if

    • cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
    • symptoms do not improve within 7 days or are accompanied by fever
    • nervousness, dizziness, or sleeplessness occur

    If pregnant or breastfeeding

    ask a health professional before use.

    Keep out of reach of children.

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

  • Directions


    • use only with enclosed measuring cup
    • do not use enclosed measuring cup for any other drug product
    Adults and children 12 years of age and older:
    2 teaspoonfuls (tsp) every 6 hours not to exceed 8 teaspoonfuls in 24 hours, or as directed by a doctor.
    Children 6 to under 12 years of age:
    1 teaspoonful (tsp) every 6 hours not to exceed 4 teaspoonfuls in 24 hours, or as directed by a doctor.
    Children 2 to under 6 years of age:
    Consult a doctor.
  • Other information

    • Store at room temperature 15°C-30°C (59°F-86°F)
  • Inactive ingredients

    Bitter Mask, Citric Acid Anhydrous, Glycerin, Grape Flavor, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol.

  • Questions?

    Call 1-787-701-3312. You may also report serious side effects to this phone number.

  • Product Labels

    Deltuss DMX Labeling 1

    Deltuss DMX Labeling 2

  • INGREDIENTS AND APPEARANCE
    DELTUSS DMX COUGH SUPPRESSANT NASAL DECONGESTANT ANTIHISTAMINE GRAPE FLAVOR 
    dexchlorpheniramine maleate, dextromethorphan hydrobromide, pseudoephedrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58238-225
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXCHLORPHENIRAMINE MALEATE (UNII: B10YD955QW) (DEXCHLORPHENIRAMINE - UNII:3Q9Q0B929N) DEXCHLORPHENIRAMINE MALEATE1 mg  in 5 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 5 mL
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPE (Grape Flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58238-225-041 in 1 CARTON03/20/2015
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/20/2015
    Labeler - Deliz Pharmaceutical Corp (826391138)
    Establishment
    NameAddressID/FEIBusiness Operations
    Woodfield Pharmaceutical, LLC079398730manufacture(58238-225)