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Rescon DM (Capellon Pharmaceuticals, LLC)

Available Formats

Dosage Form Package Information Links
LIQUID 473 mL in 1 BOTTLE (64543-105-16) Label Information
LIQUID 25 mL in 1 BOTTLE (64543-105-01) Label Information
LIQUID 118 mL in 1 BOTTLE (64543-105-04) Label Information

Complete Rescon DM Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • Active Ingredients

    Chlorpheniramine Maleate 2 mg

    Dextromethorphan HBr 10 mg

    Pseudoephedrine HCl, USP 30 mg


  • Purpose

    Chlorpheniramine Maleate Antihistamine

    Dextromethorphan HBr Antitussive (cough suppressant)

    Pseudoephedrine HCl Nasal Decongestant


  • Usage

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

    • cough due to minor throat and bronchial irritation
    • runny nose
    • sneezing
    • itchy, watery eyes
    • itching of the nose or throat
    • nasal congestion
    • temporarily restores freer breathing through the nose

  • Warnings

    Do not use

    • to sedate a child or make a child sleepy
    • 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 drug.

  • Ask a doctor before use if you have.

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • glaucoma
    • trouble urinating due to an enlarged prostate gland
    • a breathing problem such as emphysema or chronic bronchitis
    • a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
    • a cough that occurs with too much phlegm (mucus)

  • Ask a doctor or pharmacist before use if you are

    • taking any other nasal decongestant or stimulant
    • taking sedatives or tranquilizers

  • When using this product

    Do not exceed recommended dosage.

    • marked drowsiness may occur
    • avoid alcoholic beverages
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery
    • excitability may occur, especially in children

  • Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur.
    • cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition.

  • 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

    Do not exceed 4 doses in a 24 hour period.

    Age Dose
    Adults and children over 12 years of age 2 teaspoonsful (10 mL) every 4 hours
    Children 6 to under 12 years of age 1 teaspoonsful (5 mL) every 4 hours
    Children under 6 years of age Ask your doctor

  • Other Information

    • store at 20°-25°C (68°-77°F)
    • tamper evident: do not use if foil seal under the cap is broken or missing
    • contains less than 1 mg sodium in each 5 mL teaspoonful

  • Inactive Ingredients

    cherry flavor, methylparaben, polyethylene glycol, propylparaben, purified water, saccharin sodium, and sorbitol


  • Questions or Comments?

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


  • Principal Display Panel

    Figure 1: 16 oz. bottle label

    85cac3dd-figure-01

  • INGREDIENTS AND APPEARANCE
    RESCON DM  
    chlorpheniramine maleate, dextromethorphan hydrobromide, and pseudoephedrine hydrochloride liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:64543-105
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 2 mg  in 5 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg  in 5 mL
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor CHERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:64543-105-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/01/1999
    2 NDC:64543-105-04 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/01/1999
    3 NDC:64543-105-01 25 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/01/1999
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 01/01/1999
    Labeler - Capellon Pharmaceuticals, LLC (124568093)
    Establishment
    Name Address ID/FEI Business Operations
    Sovereign Pharmaceuticals, LLC 623168267 manufacture(64543-105)