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Rescon (Capellon Pharmaceuticals, LLC)

Available Formats

Dosage Form Package Information Links
TABLET, MULTILAYER 1 TABLET, MULTILAYER in 1 POUCH (64543-097-02) Label Information
TABLET, MULTILAYER 90 TABLET, MULTILAYER in 1 BOTTLE (64543-097-90) Label Information

Complete Rescon Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • Active Ingredients (per tablet)

    Dexchlorpheniramine Maleate 2 mg

    Pseudoephedrine Hydrochloride 60 mg


  • Purpose

    Dexchlorpheniramine Maleate Antihistamine

    Pseudoephedrine Hydrochloride Nasal Decongestant


  • Uses

    For the temporary relief of

    • runny nose
    • sneezing
    • itching of the nose or throat
    • itchy, watery eyes due to hay fever or other upper respiratory allergies
    • nasal congestion

    Temporarily helps

    • clear nasal passages
    • shrink swollen membranes

  • Warnings

    • Do not exceed recommended dosage
    • May cause excitability especially in children
    • May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect.

  • When using this product

    • Avoid alcoholic beverages
    • Use caution when driving a motor vehicle or operating machinery.

  • Do not use

    • If you have a breathing problem such as emphysema or chronic bronchitis
    • 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

  • 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.

  • Ask a doctor before use if you have

    • glaucoma
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • difficulty in urination due to enlargement of the prostate gland
    • or if you are taking sedatives or tranquilizers

  • If pregnant or breast feeding

    Ask a health professional before use.


  • Keep out of the reach of children

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


  • Directions

    • Adults (12 and older): One tablet every 4 to 6 hours. Not to exceed 4 doses in 24 hours.
    • Children under 12 years of age: Consult a physician.

    Other information

    store at 20°-25°C (68°-77°F)


  • Inactive ingredient

    colloidal silicon dioxide, crospovidone polyplasdone, D&C Red #30, D&C Yellow #10, FD&C Blue #1, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone


  • Questions or Comments?

    Serious side effects may be reported to this number, call (817) 595-5820. (8 am to 5)


  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Figure 1: 90 ct product label

    figure-01

  • INGREDIENTS AND APPEARANCE
    RESCON 
    dexchlorpheniramine maleate and pseudoephedrine hydrochloride tablet, multilayer
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:64543-097
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DEXCHLORPHENIRAMINE MALEATE (UNII: B10YD955QW) (DEXCHLORPHENIRAMINE - UNII:3Q9Q0B929N) DEXCHLORPHENIRAMINE MALEATE 2 mg
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg
    Inactive Ingredients
    Ingredient Name Strength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE K30 (UNII: U725QWY32X)  
    Product Characteristics
    Color yellow, purple Score no score
    Shape OVAL Size 15mm
    Flavor Imprint Code RES11
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:64543-097-90 90 in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2012
    2 NDC:64543-097-02 1 in 1 POUCH; Type 0: Not a Combination Product 03/30/2012
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 03/30/2012
    Labeler - Capellon Pharmaceuticals, LLC (124568093)