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Maxiphen DM (MCR American Pharmaceuticals, Inc.)

Available Formats

Dosage Form Package Information Links
TABLET 100 TABLET in 1 BOTTLE, PLASTIC (58605-423-01) Label Information
TABLET 20 TABLET in 1 BLISTER PACK (58605-423-02) Label Information

Complete Maxiphen DM Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • ACTIVE INGREDIENT

    Active Ingredients
    (in each immediate-release tablet)
    Purpose
    Dextromethorphan HBr 20 mg Antitussive
    Guaifenesin 400 mg Expectorant
    Phenylephrine HCl 10 mg Nasal Decongestant

  • Uses

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

    • cough due to minor throat or bronchial irritation associated with a cold
    • cough impulses without narcotics
    • helps loosen phlegm and thin bronchial secretions to make coughs more productive
    • nasal congestion
    • runny nose
    • sneezing
    • itching of the nose or throat
    • itchy, watery eyes

  • Warnings

    • Do not exceed recommended dosage.

    • a persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor

    Do not use
    • 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

    Ask a doctor before use if you have
    • a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or if cough is accompanied by excessive phlegm
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • difficulty in urination due to enlargement of the prostate gland

    Ask a doctor before use if you are taking sedatives or tranquilizers

    Stop use and ask a doctor if
    • nervousness, dizziness or sleeplessness occur

    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 recommended dosage.

    Adults and children 12 years of age and over: 1 tablet by mouth 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 by mouth every 4 hours, not to exceed 3 tablets in 24 hours, or as directed by a doctor

  • Inactive ingredients

    Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate


  • Question? Comments?

    Call 1-352-754-8587


  • PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

    NDC 58605-0423-01

    100 tablets

    Maxiphen DM

    Antitussive Expectorant Nasal Decongestant

    Each immediate-release tablet contains:
    Dextromethorphan HBr 20 mg
    Guaifenesin 400 mg
    Phenylephrine HCl 10 mg

    This bottle is not be dispensed to consumer.

    Dispense in a tight light-resistant container with
    a child-resistant cap.

    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.

    MCR American

    Principal Display Panel - 100 Tablet Bottle Label

  • INGREDIENTS AND APPEARANCE
    MAXIPHEN DM 
    guaifenesin, phenylephrine hydrochloride, and dextromethorphan hydrobromide tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:58605-423
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin 400 mg
    Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride 10 mg
    Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide 20 mg
    Inactive Ingredients
    Ingredient Name Strength
    Magnesium Stearate (UNII: 70097M6I30)  
    Cellulose, Microcrystalline (UNII: OP1R32D61U)  
    Sodium Starch Glycolate Type A Potato (UNII: 5856J3G2A2)  
    Product Characteristics
    Color WHITE Score 2 pieces
    Shape OVAL (Capsule Shaped) Size 16mm
    Flavor Imprint Code MAXIPHEN;DM
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:58605-423-01 100 in 1 BOTTLE, PLASTIC
    2 NDC:58605-423-02 20 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 03/31/2008
    Labeler - MCR American Pharmaceuticals, Inc. (783383011)
    Establishment
    Name Address ID/FEI Business Operations
    MCR American Pharmaceuticals, Inc. 783383011 MANUFACTURE
    Establishment
    Name Address ID/FEI Business Operations
    TG United Inc 172837085 MANUFACTURE