Label: M-CLEAR WC- codeine phosphate, guaifenesin liquid

  • NDC Code(s): 12830-717-16, 12830-717-30
  • Packager: R.A. McNeil Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: CV
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated February 3, 2017

If you are a consumer or patient please visit this version.

  • 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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