Label: ZODRYL DEC 50 - codeine phosphate, guaifenesin and pseudoephedrine hydrochloride suspension

  • 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 August 24, 2009

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

  • OTC - ACTIVE INGREDIENT

    Codeine phosphate 1 mg/1mL: cough suppressant; Guaifenesin 20 mg/1mL: expectorant; Pseudoephedrine hydrochloride 6 mg/1mL: decongestant

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  • PURPOSE

    Temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants; the intensity of coughing; the impulse to cough to help you go to sleep; temporarily relieves nasal congestion due to a cold; temporarily restores freer breathing through the nose; helps loosen phlegm (mucus) and thin bronchial passageways of bothersome mucus and makes coughs more productive

    Warnings

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  • OTC - DO NOT USE

    in children who have chronic pulmonary disease, shortness of breath, or such as occurs with asthma or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor; if taking a monoamine oxidase inhibitor (MAOI)

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  • OTC - ASK DOCTOR

    if your child has glaucoma, a breathing problem such as emphysema or chronic bronchitis, heart disease, high blood pressure, thyroid disease, diabetes.

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  • OTC - ASK DOCTOR/PHARMACIST SECTION

    if you or your child are taking sedatives or tranquilizers; if you or your child are taking prescription MAOI (certain drugs for depression, psychiatric, or emotional conditions), or for 2 weeks after stopping the MAOI drug.

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  • OTC - WHEN USING THIS PRODUCT

    do not exceed recommended dosage; may cause or aggravate constipation; if nervousness, dizziness, or sleepiness occur, discontinue use and consult a doctor

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  • OTC - 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.

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  • OTC - KEEP THESE AND ALL DRUGS OUT OF REACH OF CHILDREN

    In case of overdose, seek professional assistance for contact a Poison Control Center immediately.

    Directions:

    • Take every 4-6 hours

    • Use only with enclosed calibrated oral dispenser

    • Do not take more than 4 doses in 24 hours or as directed by a doctor

    Children 6 to under 12 years of age:  5mL

    Other information store at controlled room temperature 20°-25°C (68°-77°F).

    INACTIVE INGREDIENT

    Bittermask, citric acid, FD& C blue #1, FD& C red #40, galloquinate, glycerin, grape flavor, magnesium aluminometasilicate, methylparaben, purified water, sodium citrate dihydrate, sucralose, xanthan gum

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  • OTC – QUESTIONS SECTION

    Call 1-866-574-8861 24 hours a day, 7 days a week.

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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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    Figure 1.  Primary Label- Front Page

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    Figure 2. Primary Label – Second Page

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    Figure 3. Primary Label – Last Page

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  • INGREDIENTS AND APPEARANCE
    ZODRYL DEC 50 
    codeine phosphate, guaifenesin and pseudoephedrine hydrochloride suspension
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:43378-124
    Route of Administration ORAL DEA Schedule CV    
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg  in 5 mL
    CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE - UNII:Q830PW7520) CODEINE PHOSPHATE 5 mg  in 5 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 100 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    TANNIC ACID (UNII: 28F9E0DJY6)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Color purple Score     
    Shape Size
    Flavor GRAPE Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:43378-124-08 236 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 08/24/2009
    Labeler - CodaDose, Inc. (831355115)
    Registrant - Gorbec Pharmaceutical Services Inc. (791919678)
    Establishment
    Name Address ID/FEI Business Operations
    Gorbec Pharmaceutical Services Inc. 791919678 manufacture
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