Label: ACTICON- dexbrompheniramine maleate, pseudoephedrine hydrochloride tablet

  • 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 12, 2018

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

  • Drug Facts

  • Active ingredients (in each tablet)

    Dexbrompheniramine Maleate, USP 2 mg

    Pseudoephedrine HCl, USP 60 mg

  • Purpose

    Antihistamine

    Nasal Decongestant

  • Keep out of reach of children.

    In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

  • INDICATIONS & USAGE

    Uses Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
    • runny nose • sneezing
    • itching of the nose or throat
    • itchy, watery eyes
    • nasal congestion
    • reduces swelling of nasal passages

  • Warnings

    Do not exceed recommended dosage.

    Do not use this product

    • 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 taking this product

    Ask a doctor before use if you have

    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes mellitus
    • difficulty in urination due to enlargement of the prostate gland

    Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor.

    When using this product
    • excitability may occur, especially in children
    • may cause drowsiness
    • alcohol, sedatives and tranquilizers may increase drowsiness
    • avoid alcoholic beverages
    • use caution when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if
    • nervousness, dizziness, or sleeplessness occur
    • if symptoms do not improve within 7 days or are accompanied by fever
    • new symptoms occur

    If pregnant or breast feeding, ask a health professional before use.

  • Directions

    Do not exceed recommended dosage.

    Adults and children 12 years of age and over:1 tablet every 4 to 6 hours not to exceed 4 tablets in 24 hours or as directed by a doctor
    Children 6 to under 12 years of age:1/2 tablet every 4 to 6 hours not to exceed 2 tablets in 24 hours or as directed by a doctor
    Children under 6 years of ageConsult a doctor

  • Inactive ingredients

    Magnesium stearate, microcrystalline cellulose, sodium starch glycolate

  • Other information

    Store at 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].

  • Questions or Comments?

    Call 787-608-0882

  • SPL UNCLASSIFIED SECTION

    Manufactured in the USA for ActiPharma, Inc. Dorado, PR 00646. Tel: (787) 608-0882

    *Conex® Tablets is a registered trademark of Llorens Pharmaceutical Corp. This product is not manufactured, distributed or marketed by Llorens Pharmaceutical Corp.

    Contains the same active ingredients as Conex® Tablets*

    ANTIHISTAMINE  NASAL DECONGESTANT

    Tamper evident by foil seal under cap.

    Do not use if foil seal is broken or missing.

  • Packaging

    imga1

  • INGREDIENTS AND APPEARANCE
    ACTICON 
    dexbrompheniramine maleate, pseudoephedrine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63102-401
    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
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeOVALSize13mm
    FlavorImprint Code A401
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63102-401-6060 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/13/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/13/2015
    Labeler - Actipharma, Inc (079340948)