Zodryl AC 50
Dosage form: suspension
Ingredients: CHLORPHENIRAMINE MALEATE 2mg in 5mL, CODEINE PHOSPHATE 5mg in 5mL
Labeler: CodaDose, Inc.
NDC Code: 43378-104
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.
Chlorpheniramine maleate 0.400 mg/1mL: antihistamine; Codeine phosphate 1 mg/1mL: cough suppressant
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
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
before use if you or your child has glaucoma; a breathing problem such as emphysema or chronic bronchitis
if you or your child are taking sedatives or tranquilizers
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
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.
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 6 to under 12 years of age: 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
Call 1-866-574-8861 24 hours a day, 7 days a week.
Figure 1. Primary Label- Front Page
Figure 2. Primary Label – Second Page
Figure 3. Primary Label – Last Page
| ZODRYL AC 50
chlorpheniramine maleate and codeine phosphate suspension |
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| Labeler - CodaDose, Inc. (831355115) |
| Registrant - Gorbec Pharmaceutical Services Inc. (791919678) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Gorbec Pharmaceutical Services Inc. | 791919678 | manufacture | |
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
