Label: CONEX- dexbrompheniramine maleate, pseudoephedrine liquid

  • NDC Code(s): 54859-802-16
  • Packager: Llorens Pharmaceutical International Division
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 27, 2024

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

  • ACTIVE INGREDIENT

    Active Ingredients (in each 5 mL tsp.)

    Dexbrompheniramine Maleate, USP .......... 1 mg .................... Antihistamine

    Pseudoephedrine HCL, USP ............ 30 mg ...................... Nasal Decongestant


  • PURPOSE

    Uses:

    • Temporarily relieves nasal congestion due to common cold, hay fever or other upper respiratory allergies
    • Helps decongest sinus openings and sinus passages
    • Reduces swelling of nasal passages, shrinks swollen membranes, and temporarily restores freer breathing through the nose
    • Temporarily alleviates the following symtoms due to hay fever (allergic rhinitis) : runny nose, sneezing, itching of the nose or throat, itchy and watery eyes.


  • WARNINGS

    Warnings:

    • Do not use ifyou are 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 you are taking a prescription drug that contains an MAOI, ask your doctor or pharmacist before taking this product.
  • DO NOT USE

    Ask a doctor before use if you aretaking sedatives or tranquilizers.

    Ask a doctor before use if you have

    •  heart disease
    • high blood pressure
    • thyroid disese
    • diabetes
    • glucoma
    • difficulty in urination due to the enlargement of the prostate gland.

    When using this product

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

    Stop use and ask a doctor if

    • nervousness, dizziness or sleeplessness occur
    • symptoms do not improve within 7 days or occur with a fever.


  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding,ask a Health Professional before use.

  • DOSAGE & ADMINISTRATION

    Directions:Do not exceed more than 4 doses in any 24-hour period or as directed by a doctor.

     Age
     Dose
     Adults and children 12 years of age and over
     take two teaspoonfuls (10 mL) every 4 to 6 hours
     Children 6 to under 12 years of age
     take one teaspoonful (5 mL) every 4 to 6 hours
     Children under 6 years of age
     ask a doctor
  • INDICATIONS & USAGE

    Other Information:

    • Store at controlled room temperature 20-25 degree celcius ( 68-77 degree farenheit); excursions permitted to 15-30 degree clecius (59-86 degree farenheit) (See USP Controlled Room Temperture) Tamper evident by imprinted heat seal under cap
    • Do not use if there is evidence of tampering
    • WARNING: Phenylketonuric: Contains 13.5 mg of Phenylalanine per 5 mL (one teaspoonful) dose.
  • INACTIVE INGREDIENT

    Inactive Ingredients: citric acid, glycerine, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate and sucralose

  • QUESTIONS

    Questions or Comments? 1-866-595-5598

  • PRINCIPAL DISPLAY PANEL

    Ocnex

  • INGREDIENTS AND APPEARANCE
    CONEX 
    dexbrompheniramine maleate, pseudoephedrine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54859-802
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXBROMPHENIRAMINE MALEATE (UNII: BPA9UT29BS) (DEXBROMPHENIRAMINE - UNII:75T64B71RP) DEXBROMPHENIRAMINE MALEATE1 mg  in 5 mL
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    WATER (UNII: 059QF0KO0R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL (UNII: L7T10EIP3A)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54859-802-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product12/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01211/01/2007
    Labeler - Llorens Pharmaceutical International Division (037342305)