Label: ZODRYL AC 60- chlorpheniramine maleate and codeine phosphate 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

    Chlorpheniramine maleate 0.266 mg/1mL: antihistamine; Codeine phosphate 1 mg/1mL: cough suppressant

  • OTC - 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 decreases runny nose and reduces sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever or other upper respiratory allergies

    Warnings

  • OTC - DO NOT USE

    in children who have chronic pulmonary disease, shortness of breath, or who are taking other drugs unless directed by a doctor; for persistent or chronic cough such as occurs with asthma or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor

  • OTC - ASK DOCTOR

    before use if you or your child has glaucoma; a breathing problem such as emphysema or chronic bronchitis

  • OTC - ASK DOCTOR/PHARMACIST

    if you or your child are taking sedatives or tranquilizers

  • OTC - WHEN USING

    do not exceed recommended dosage; may cause or aggravate constipation; may cause excitability in children; may cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect

  • OTC - STOP USE

    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 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:  7.5mL

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

    INACTIVE INGREDIENT

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

  • OTC - QUESTIONS

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

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    80883522-figure-01

    Figure 1. Primary Label- Front Page

    80883522-figure-02

    Figure 2. Primary Label – Second Page

    80883522-figure-03

    Figure 3. Primary Label – Last Page

  • INGREDIENTS AND APPEARANCE
    ZODRYL AC 60 
    chlorpheniramine maleate and codeine phosphate suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43378-105
    Route of AdministrationORALDEA ScheduleCV    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE1.995 mg  in 7.5 mL
    CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE - UNII:Q830PW7520) CODEINE PHOSPHATE7.5 mg  in 7.5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    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
    ColorredScore    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43378-105-08236 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/24/2009
    Labeler - CodaDose, Inc. (831355115)
    Registrant - Gorbec Pharmaceutical Services Inc. (791919678)
    Establishment
    NameAddressID/FEIBusiness Operations
    Gorbec Pharmaceutical Services Inc.791919678manufacture