Label: ACTICON- dexbrompheniramine maleate, pseudoephedrine hydrochloride liquid

  • Category: HUMAN OTC DRUG LABEL

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 5, 2018

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Drug Facts

  • Active Ingredients (in each 5 mL tsp)

    Dexbrompheniramine Maleate, 1 mg

    Pseudoephedrine HCl, 30 mg

  • Purpose

    Antihistamine

    Nasal Decongestant

  • Uses:

    Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper

    respiratory allergies:

    • relieves sinus congestion and pressure, helps decongest sinus openings and passages

    • restores freer breathing through the nose

    • runny nose • sneezing • itching of the nose or throat • itchy, watery eyes • nasal congestion

  • 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 • 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 effect

    • 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 accompanined by fever • new symptoms occur

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

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

  • Directions:

    • Adults and children 12 years of age and over: Take 2 teaspoonfuls (10 mL) every 4-6 hours as needed, do not exceed 4 teaspoonfuls in 24 hours, or as directed by a doctor.

    • Children 6-12 years: Take 1 teaspoonful (5 mL) every 4-6 hours as needed, do not exceed 2 teaspoonfuls in 24 hours, or as directed by a doctor.

    • Children under 6 years of age: consult a doctor.

  • Other Information:

    • Tamper Evident. Do not use if inner seal is torn, cut, or opened.

    • Store at controlled room temperature 15°- 30ºC (59°- 86ºF)

    Avoid excessive heat or humidity.

  • Inactive Ingredients:

    citric acid, flavor, glycerin, methyl paraben, propylene glycol, propyl paraben, purified water, sodium citrate, sucralose

  • SPL UNCLASSIFIED SECTION

    Contains the same active ingredients as Conex®*

    Manufactured in the USA for ActiPharma, Inc.

    Dorado, PR 00646. Tel: (787) 608-0882

    * Conex® is a registered trademark of Llorens

    Pharmaceutical Corp. This product is not manufactured, distributed or marketed by Llorens Pharmaceutical Corp.

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    ACTICON 
    dexbrompheniramine maleate, pseudoephedrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63102-105
    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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63102-105-16480 mL in 1 PACKAGE; Type 0: Not a Combination Product07/14/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/14/2016
    Labeler - ACTIPHARMA, INC. (079340948)
    Registrant - ACTIPHARMA, INC. (079340948)