Label: DELTUSS DP NASAL DECONGESTANT ANTIHISTAMINE CHERRY FLAVOR- dexchlorpheniramine maleate, pseudoephedrine 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 November 2, 2021

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  • Drug Facts


  • Active ingredients (in each 5 mL teaspoonful)

    Dexchlorpheniramine maleate 1 mg
    Pseudoephedrine HCl 30 mg

    Purpose

    Antihistamine

    Nasal Decongestant

  • Uses

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


    Do not use 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 giving 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

    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

    • 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

    cherry flavor, citric acid, glycerin, 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.

  • DELTUSS DP Nasal Decongestant Antihistamine CHERRY Flavor 4oz/118ml (58238-226-04)

    Deltuss DP Labeling 1

    Deltuss DP Labeling 2

  • INGREDIENTS AND APPEARANCE
    DELTUSS DP NASAL DECONGESTANT ANTIHISTAMINE CHERRY FLAVOR 
    dexchlorpheniramine maleate, pseudoephedrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58238-226
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXCHLORPHENIRAMINE MALEATE (UNII: B10YD955QW) (DEXCHLORPHENIRAMINE - UNII:3Q9Q0B929N) DEXCHLORPHENIRAMINE MALEATE1 mg  in 5 mL
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    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
    FlavorCHERRY (Cherry Flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58238-226-041 in 1 PACKAGE03/20/2015
    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(58238-226)
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