M-CLEAR WC (CODEINE PHOSPHATE, GUAIFENESIN) LIQUID [R.A. MCNEIL COMPANY]

M-CLEAR WC (CODEINE PHOSPHATE, GUAIFENESIN) LIQUID [R.A. MCNEIL COMPANY]
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NDC 12830-717-16, 12830-717-30
Set ID 903fe5b6-6c28-4b92-bdab-32389c10c25a
Category HUMAN OTC DRUG LABEL
Packager R.A. McNeil Company
Generic Name
Product Class
Product Number
Application Number PART341
  • Drug Facts

    Active ingredients
    (in each 5 mL teaspoonful)

    Codeine Phosphate* 6.33 mg
    *WARNING:  May be habit-forming

    Guaifenesin 100 mg

    Purpose

    Antitussive

    Expectorant

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  • Uses

    temporarily relieves these symptoms due to the common cold:

    • cough due to minor throat and bronchial irritation
    • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
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  • Warnings

    Do not exceed recommended dosage.

    Ask a doctor before use if you have

    • a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
    • a cough that occurs with too much phlegm (mucus)
    • chronic pulmonary disease or shortness of breath, or children who are taking other drugs

    Stop use and ask a doctor if

    • cough 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.
    • may cause or aggravate constipation
    • new symptoms 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.

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  • Directions

    Do not exceed recommended dosage.

    Adults and children
    12 years of age
    and over:

    3 teaspoonfuls (15 mL)
    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
    (7.5 mL) 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

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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, 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
  • INGREDIENTS AND APPEARANCE
    M-CLEAR  WC
    codeine phosphate, guaifenesin liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:12830-717
    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
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 100 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:12830-717-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/30/2008
    2 NDC:12830-717-30 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/30/2008
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 10/30/2008
    Labeler - R.A. McNeil Company (008305220)
    Establishment
    Name Address ID/FEI Business Operations
    Woodfield Pharmaceutical, LLC 079398730 manufacture(12830-717)
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