Label: RESCON- dexchlorpheniramine maleate and pseudoephedrine hydrochloride tablet, multilayer

  • NDC Code(s): 64543-097-02, 64543-097-90
  • Packager: Capellon Pharmaceuticals, LLC
  • 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 November 6, 2019

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

  • 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:64543-097
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXCHLORPHENIRAMINE MALEATE (UNII: B10YD955QW) (DEXCHLORPHENIRAMINE - UNII:3Q9Q0B929N) DEXCHLORPHENIRAMINE MALEATE2 mg
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE60 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    Coloryellow, purpleScoreno score
    ShapeOVALSize15mm
    FlavorImprint Code RES11
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64543-097-9090 in 1 BOTTLE; Type 0: Not a Combination Product03/30/2012
    2NDC:64543-097-021 in 1 POUCH; Type 0: Not a Combination Product03/30/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/30/2012
    Labeler - Capellon Pharmaceuticals, LLC (124568093)