Label: ED-A-HIST DM- chlorpheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride tablet, coated

  • NDC Code(s): 0485-0240-01
  • Packager: EDWARDS PHARMACEUTICALS, INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated January 29, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredients (in each tablet)Purpose
    Chlorpheniramine Maleate 4 mgAntihistamine
    Dextromethorphan HBr 10 mgAntitussive
    Phenylephrine HCl 10 mgNasal Decongestant
  • Uses

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

    • runny nose
    • sneezing
    • itching of the nose or throat
    • itchy, watery eyes
    • cough due to minor throat and bronchial irritation
    • nasal congestion
    • reduces swelling of nasal passages
  • 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

    Do not use this product, unless directed by a doctor, if you have

    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma
    • a persistent or chronic cough that occurs with too much phlegm (mucus)
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes mellitus
    • 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 marked drowsiness
    • 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
    • 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.
    • new symptoms occur

    If pregnant or breastfeeding, 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 recommended dosage.

    Adults and children 12 years of age and over:1 tablet every 4 hours, not to exceed 6 tablets in 24 hours, or as directed by a doctor
    Children 6 to under 12 years of age:1/2 tablet every 4 hours, not to exceed 3 tablets in 24 hours, or as directed by a doctor
    Children under 6 years of age:Consult a doctor.
  • Inactive ingredients

    Lake blend purple, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

  • Questions or Comments?

    Call 1-800-543-9560   Rev. 08/14

  • PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

    NDC 0485-0240-01

    ED A-HIST DM TABLETS

    Antihistamine • Antitussive • Nasal Decongestant

    Each tablet contains:
    Chlorpheniramine Maleate    4 mg
    Dextromethorphan HBr    10 mg
    Phenylephrine HCl    10 mg

    Store at 59°-86°F (15°-30°C) [see USP Controlled Room Temperature].
    Tamper evident by foil seal under cap.
    Do not use if foil seal is broken or missing.

    Manufactured for:
    EDWARDS
    Pharmaceuticals, Inc.
    Ripley, MS 38663

    100 tablets

    PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label
  • INGREDIENTS AND APPEARANCE
    ED-A-HIST DM 
    chlorpheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0485-0240
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    Product Characteristics
    ColorpurpleScore2 pieces
    ShapeOVALSize16mm
    FlavorImprint Code ED;DM
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0485-0240-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/27/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/27/2014
    Labeler - EDWARDS PHARMACEUTICALS, INC. (195118880)
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