Zodryl Ac 40
FDA Label NDC 43378-103

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

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.

Otc - Active Ingredient

Chlorpheniramine maleate 0.222 mg/1mL: antihistamine; Codeine phosphate 1 mg/1mL: cough suppressant

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 Section

if you or your child are taking sedatives or tranquilizers

Otc - When Using This Product

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 And Ask A Doctor If

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 These And All Drugs 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 2 to under 6 years of age:  ask a doctor

    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 Section

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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