Zodryl DEC 80
Dosage form: suspension
Ingredients: PSEUDOEPHEDRINE 30mg in 10mL, CODEINE PHOSPHATE 10mg in 10mL, GUAIFENESIN 200mg in 10mL
Labeler: CodaDose, Inc.
NDC Code: 43378-126
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.
Codeine phosphate 1 mg/1mL: cough suppressant; Guaifenesin 20 mg/1mL: expectorant; Pseudoephedrine hydrochloride 3 mg/1mL: decongestant
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
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)
if your child has glaucoma, a breathing problem such as emphysema or chronic bronchitis, heart disease, high blood pressure, thyroid disease, diabetes.
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.
do not exceed recommended dosage; may cause or aggravate constipation; if nervousness, dizziness, or sleepiness occur, discontinue use and consult a doctor
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: 10mL
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
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 DEC 80
codeine phosphate, guaifenesin and pseudoephedrine hydrochloride 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.
