Label: CONEX- dexbrompheniramine maleate, pseudoephedrine liquid

  • NDC Code(s): 54859-802-04
  • Packager: Llorens Pharmaceutical International Division
  • 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 December 23, 2020

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 if you 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 are taking 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: aspartame, cherry flavor, citric acid, glycerine, menthol, methylparaben, potassium citrate, potassium sorbate, propylene glycol, propylparaben and purified water.

  • QUESTIONS

    Questions or Comments? 1-866-595-5598

  • PRINCIPAL DISPLAY PANEL

    ConexLabel

  • 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
    ASPARTAME (UNII: Z0H242BBR1)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL (UNII: L7T10EIP3A)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRY (cherry flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54859-802-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product11/01/2007
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34111/01/2007
    Labeler - Llorens Pharmaceutical International Division (037342305)