RESCON DM (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [CAPELLON PHARMACEUTICALS, LLC]

RESCON DM (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [CAPELLON PHARMACEUTICALS, LLC]
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NDC 64543-105-01, 64543-105-04, 64543-105-16
Set ID ed6e770f-a491-4ffe-8160-24b6a5ac9c6d
Category HUMAN OTC DRUG LABEL
Packager Capellon Pharmaceuticals, LLC
Generic Name
Product Class alpha-Adrenergic Agonist
Product Number
Application Number PART341
  • 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 age2 teaspoonsful (10 mL) every 4 hours
    Children 6 to under 12 years of age1 teaspoonsful (5 mL) every 4 hours
    Children under 6 years of ageAsk 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:64543-105
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg  in 5 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    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    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64543-105-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/1999
    2NDC:64543-105-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/1999
    3NDC:64543-105-0125 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/1999
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/01/1999
    Labeler - Capellon Pharmaceuticals, LLC (124568093)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sovereign Pharmaceuticals, LLC623168267manufacture(64543-105)