FDA Label for Zodryl Ac 60
View Indications, Usage & Precautions
Zodryl Ac 60 Product Label
The following document was submitted to the FDA by the labeler of this product Codadose, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
Figure 1. Primary Label- Front Page Figure 2. Primary Label – Second Page Figure 3. Primary Label – Last Page
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