Label: CONEX- dexbrompheniramine maleate, pseudoephedrine hcl tablet

  • NDC Code(s): 54859-702-60
  • Packager: LLORENS PHARMACEUTICALS 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 film coated tablet)                         Purpose

    Dexbrompheniramine Maleate, USP ................ 2 mg .................. Antihistamine

    Pseudeophedrine HCl, USP .................... 60 mg ..........................Nasal Decogestant

  • PURPOSE


    Uses
    • Temporarily relieves nasal congestion due to the 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 symptoms due to hay fever (allergic rhinitis): runny nose, sneezing, itching of the nose or throat, itching and watery eyes.

  • WARNINGS

    Warnings:

    Ask a doctor before you use if you are
    • taking sedatives or tranquilizers.
    Ask your doctor before use if you have
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • glaucoma
    • 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 doctor if
    • nervousness, dizziness or sleepiness occur
    • symptoms do not improve withing 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.

  • DO NOT USE

    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 MAOI;

    ask your doctor or pharmacist before taking this product.

  • DOSAGE & ADMINISTRATION

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

     Adults and children
     12 years of age and over
     Take one tablet
     every 4 to 6 hours
     Children 6 to under
     12 years of age
     1/2 tablet
     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 celsius (68 - 77 degree fahrenheit); excursions permitted to

    15 - 30 degree celsius ( 59 - 86 degree fahrenheit) [ See USP Controlled Room Temperature] Tamper evident by imprinted heat seal

    under cap. Do not use if there is evidence of tampering.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Dicalcium Phosphate, Microcrystalline Cellulose, Magnesium Stearate, Sodium Starch Glycolate type B, Purified Water, Red iron Oxide, Yellow Iron Oxide, Titanium Dioxide.

  • QUESTIONS

    Questions or Comments?                 1-866-595-5598

  • PRINCIPAL DISPLAY PANEL

    ConexTabLabel

  • INGREDIENTS AND APPEARANCE
    CONEX 
    dexbrompheniramine maleate, pseudoephedrine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54859-702
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXBROMPHENIRAMINE MALEATE (UNII: BPA9UT29BS) (DEXBROMPHENIRAMINE - UNII:75T64B71RP) DEXBROMPHENIRAMINE MALEATE2 mg
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE60 mg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SODIUM STARCH GLYCOLATE TYPE B POTATO (UNII: 27NA468985)  
    WATER (UNII: 059QF0KO0R)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize13mm
    FlavorImprint Code LLORENS
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54859-702-6060 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 PHARMACEUTICALS INTERNATIONAL DIVISION (037342305)
    Registrant - LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION (037342305)