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Zodryl DEC 50 (CodaDose, Inc.)

Available Formats

Dosage Form Package Information Links
SUSPENSION 236 mL in 1 BOTTLE, PLASTIC (43378-124-08) Label Information

Complete Zodryl DEC 50 Information

  • OTC - ACTIVE INGREDIENT

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


  • 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


  • 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)


  • 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.


  • 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.


  • 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


  • 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.


  • 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


  • OTC – QUESTIONS SECTION

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


  • 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


  • 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