Otc - Active Ingredient
Chlorpheniramine maleate 0.222 mg/1mL: antihistamine; Codeine phosphate 1 mg/1mL: cough suppressant
The following Structured Product Label (SPL) was submitted to the FDA by Codadose, Inc. for the product Zodryl Ac 40 (NDC 43378-103). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, purpose, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist section, otc - when using this product, otc - stop use and ask a doctor if, otc - keep these and all drugs out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Chlorpheniramine maleate 0.222 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:
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 2 to under 6 years of age: ask a doctor
Other information store at controlled room temperature 20°-25°C (68°-77°F).
Citric acid, FD&C red #40, galloquinate, glycerin, grape flavor, magnesium aluminometasilicate, methylparaben, purified water, sodium citrate dihydrate, sucralose, xanthan gum
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