M-END PE (CODEINE PHOSPHATE, PHENYLEPHRINE HYDROCHLORIDE, BROMPHENIRAMINE MALEATE) LIQUID [R.A. MCNEIL COMPANY]

M-END PE (CODEINE PHOSPHATE, PHENYLEPHRINE HYDROCHLORIDE, BROMPHENIRAMINE MALEATE) LIQUID [R.A. MCNEIL COMPANY]
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NDC 12830-754-12, 12830-754-30
Set ID fce1a6e4-cda3-462e-a853-049eabe4441e
Category HUMAN OTC DRUG LABEL
Packager R.A. McNeil Company
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • Drug Facts

    Active ingredients

    (in each 5 mL teaspoonful)


    Brompheniramine Maleate 1.33 mg

    Codeine Phosphate 6.33 mg

    (WARNING: May be habit-forming)

    Phenylephrine Hydrochloride 3.33 mg

    Purpose

    Antihistamine

    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:

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

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • glaucoma
    • a breathing problem such as emphysema or chronic bronchitis
    • trouble urinating due to an enlarged prostate gland
    • chronic pulmonary disease or shortness of breath, or children who are taking other drugs
    • 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 sedatives or tranquilizers.

    When using this product

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

    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 breast-feeding, ask a health professional before use.

    Keep out of the 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 recommended dosage.

    Adults and children

    12 years of age

    and over:

    3 teaspoonfuls every 4 to 6 hours,

    not to exceed 18 teaspoonfuls in a

    24 hour period

    Children 6 to under

    12 years of age:

    1 1/2 teaspoonfuls every 4 to 6 hours,

    not to exceed 9 teaspoonfuls in a

    24 hour period

    Children under 6

    years of age

    Not recommended for use

    A special measuring device should be used to give an accurate dose of this product to children under 6 years of age. Giving a higher dose than recommended by a doctor could result in serious side effects for your child.

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  • Other information

    Store at 59°-86°F (15°-30°C)

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  • Inactive ingredients

    citric acid, cotton candy flavor, FD&C Red #40, glycerin, propylene glycol, purified water, sodium citrate, sodium saccharin, sorbitol

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  • Questions? Comments?

    Call 1-423-493-9170

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  • Product Packaging

    The packaging below represents the labeling currently used.

    Principal display panel and side panel for 354 mL label:

    NDC 12830-0754-12


    M-END PE

    Antihistamine · Antitussive

    · Nasal Decongestant

    Sugar Free · Alcohol Free


    CV

    EACH 5 mL (1 TEASPOONFUL)

    CONTAINS:

    Brompheniramine Maleate ..........................1.33 mg

    Codeine Phosphate.......................................6.33 mg
    (WARNING: May be habit-forming.)

    Phenylephrine Hydrochloride.......................3.33 mg

    Cotton Candy Flavor
    12 fl. oz. (354 mL)

    Mfg. for:

    R.A. McNeil Company
    Chattanooga, TN 37406-3738

    Rev. 10/14

    Tamper evident by foil seal under cap.

    Do not use if foil seal is broken or missing.

    This package not intended for dispensing to the patient.

    M END PE Labeling

    M END PE Labeling

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  • INGREDIENTS AND APPEARANCE
    M-END  PE
    codeine phosphate, phenylephrine hydrochloride, brompheniramine maleate liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:12830-754
    Route of Administration ORAL DEA Schedule CV    
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J) CODEINE PHOSPHATE 6.33 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 3.33 mg  in 5 mL
    BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE 1.33 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)  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor COTTON CANDY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:12830-754-12 354 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/19/2014
    2 NDC:12830-754-30 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/19/2014
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 11/11/2008
    Labeler - R.A. McNeil Company (008305220)
    Registrant - Woodfield Pharmaceutical, LLC (079398730)
    Establishment
    Name Address ID/FEI Business Operations
    Woodfield Pharmaceutical, LLC 079398730 manufacture(12830-754)
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