M-END DMX (DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [R. A. MCNEIL COMPANY]

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  • M-END DMX (DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [R. A. MCNEIL COMPANY]

M-END DMX (DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [R. A. MCNEIL COMPANY]
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NDC 12830-816-16, 12830-816-30
Set ID ee1fae2e-3a21-4487-9989-c7620a4a7056
Category HUMAN OTC DRUG LABEL
Packager R. A. McNeil Company
Generic Name
Product Class alpha-Adrenergic Agonist
Product Number
Application Number PART341
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  • Drug Facts

    Active ingredients
    (in each 5 mL teaspoonful)
    Dexbrompheniramine Maleate 0.667 mg
    Dextromethorphan HBr 10 mg
    Pseudeophedrine HCl 20 mg

    Purpose

    Antihistamine

    Antitussive

    Cough Suppressant

    Nasal Decongestant

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  • Uses

    temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper 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
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  • 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

    Ask a doctor before use if you have

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

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

    When using this product

    • excitability may occur, especially in children
    • may cause marked drowsiness
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizes may increase the drowsiness effect
    • be careful when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if

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

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.

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  • Directions

    Do not exceed 4 doses in a 24 hour period.

    Adults and children
    12 years of age
    and over:

    		3 teaspoonfuls (15 mL)
    every 6 hours, not to
    exceed 12 teaspoonfuls
    in 24 hours
    Children 6 to under
    12 years of age:



    		1 1/2 teaspoonfuls
    (7.5 mL) every 6 hours,
    not to exceed 6
    teaspoonfuls in
    24 hours
    Children under 6
    years of age:
    		Consult a Physician.

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  • Other information

    Store at 59°-86°F (15°-30°C)

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  • Inactive ingredients

    Bitter Mask, Citric Acid, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol, Sucralose, Tutti Frutti Flavor.

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  • Questions? Comments?

    Call 1-423-493-9170

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  • Product Packaging

    M-END DMX Labeling 1.jpg

    M-END DMX Labeling 2.jpg

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  • INGREDIENTS AND APPEARANCE
    M-END  DMX
    dexbrompheniramine maleate, dextromethorphan hydrobromide, pseudoephedrine hydrochloride liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:12830-816
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DEXBROMPHENIRAMINE MALEATE (UNII: BPA9UT29BS) (DEXBROMPHENIRAMINE - UNII:75T64B71RP) DEXBROMPHENIRAMINE MALEATE 0.667 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 20 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor TUTTI FRUTTI Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:12830-816-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/13/2011
    2 NDC:12830-816-30 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/13/2011
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 10/13/2011
    Labeler - R. A. McNeil Company (008305220)
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