Label: ZODRYL DAC 40- chlorpheniramine maleate, codeine phosphate and pseudoephedrine hydrochloride suspension
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Contains inactivated NDC Code(s)
NDC Code(s): 43378-113-04 - Packager: CodaDose Inc.
- 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 September 22, 2009
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- Official Label (Printer Friendly)
- OTC - ACTIVE INGREDIENT
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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; 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
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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; if taking a monoamine oxidase inhibitor (MAOI)
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST SECTION
- OTC - WHEN USING THIS PRODUCT
- OTC - STOP USE AND ASK A DOCTOR IF
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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:
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Take every 4-6 hours
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Use only with enclosed calibrated oral dispenser
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Do not take more than 4 doses in 24 hours or as directed by a doctor
Children 2 to under 6 years of age: ask a doctor
Other information store at controlled room temperature 20°-25°C (68°-77°F).
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- INACTIVE INGREDIENT
- OTC – QUESTIONS SECTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ZODRYL DAC 40
chlorpheniramine maleate, codeine phosphate and pseudoephedrine hydrochloride suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43378-113 Route of Administration ORAL DEA Schedule CV Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 0.999 mg in 4.5 mL CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE - UNII:Q830PW7520) CODEINE PHOSPHATE 4.5 mg in 4.5 mL PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 14.999 mg in 4.5 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 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 blue Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43378-113-04 118 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 01/01/2040 Labeler - CodaDose Inc. (831355115) Registrant - Gorbec Pharmaceutical Services Inc. (791919678) Establishment Name Address ID/FEI Business Operations Gorbec Pharmaceutical Services Inc. 791919678 manufacture