Zodryl Dec 50
FDA Label NDC 43378-124

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 Dec 50 (NDC 43378-124). 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.

Label Section Quick Index

Otc - Active Ingredient

Codeine phosphate 1 mg/1mL: cough suppressant; Guaifenesin 20 mg/1mL: expectorant; Pseudoephedrine hydrochloride 6 mg/1mL: decongestant

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; helps loosen phlegm (mucus) and thin bronchial passageways of bothersome mucus and makes coughs more productive

Warnings

Otc - Do Not Use

in children who have chronic pulmonary disease, shortness of breath, or 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

if your child has glaucoma, a breathing problem such as emphysema or chronic bronchitis, heart disease, high blood pressure, thyroid disease, diabetes.

Otc - Ask Doctor/Pharmacist Section

if you or your child are taking sedatives or tranquilizers; if you or your child are taking prescription MAOI (certain drugs for depression, psychiatric, or emotional conditions), or for 2 weeks after stopping the MAOI drug.

Otc - When Using This Product

do not exceed recommended dosage; may cause or aggravate constipation; if nervousness, dizziness, or sleepiness occur, discontinue use and consult a doctor

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 6 to under 12 years of age:  5mL

    Other information store at controlled room temperature 20°-25°C (68°-77°F).

    INACTIVE INGREDIENT

    Bittermask, citric acid, FD& C blue #1, 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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