Zicam Sinus Relief

• Matrixx Initiatives, Inc.

Oxymetazoline nasal (for the nose) is used for temporary relief of nasal congestion caused by allergies or the common cold.

Stop using this medicine and call your doctor at once if you have ongoing or worsening symptoms, or if you have severe burning or stinging in your nose after using the nasal spray

You should not use oxymetazoline nasal if you are allergic to it.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have other medical conditions, especially:

• heart disease, high blood pressure, coronary artery disease;

• diabetes;

• a thyroid disorder; or

• enlarged prostate or urination problems.

FDA pregnancy category C. It is not known whether oxymetazoline nasal will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether oxymetazoline nasal passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Using the medication too long or too often may worsen your symptoms or cause nasal congestion to clear up and come back.

Call your doctor if your symptoms do not improve after 3 days of treatment.

Do not share this medication with another person, even if they have the same symptoms you have. Sharing a nasal spray bottle can spread infection.

To use the nose drops (nasal solution):

• Blow your nose gently. Tilt your head back as far as possible, or lie down and hang your head over the side of a bed. Hold the dropper over your nose and place the correct number of drops into your nose.

• Sit up and bend your head slightly forward, then move it gently left and right. Stay seated with your head bent forward for a few minutes.

• Avoid sneezing or blowing your nose for at least a few minutes after using the nose drops.

To use the nasal spray:

• Blow your nose gently. Keep your head upright and insert the tip of bottle into one nostril. Press your other nostril closed with your finger. Breathe in quickly and gently spray the medicine into your nose. Then use the spray in your other nostril.

• Do not blow your nose for at least a few minutes after using the nasal spray.

Do not use the nasal spray more than 2 times in 24 hours.

Wipe the tip of the spray bottle with a clean tissue but do not wash with water or soap.

Store at room temperature away from moisture and heat. Do not freeze. Keep the bottle tightly closed when not in use.

Ask a doctor or pharmacist if it is safe for you to use oxymetazoline nasal if you are also using any of the following drugs:

• an antidepressant--amitriptyline, clomipramine, desipramine, doxepin, imipramine, nortriptyline;

• ergot medicine--ergotamine, dihydroergotamine, ergonovine, methylergonovine; or

• an MAO inhibitor--isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, tranylcypromine.

This list is not complete and other drugs may interact with oxymetazoline nasal. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Applies to oxymetazoline nasal: nasal solution, nasal spray

Cardiovascular

Very rare (less than 0.01%): Tachycardia, palpitations, increased blood pressure[Ref]

Gastrointestinal

Very rare (less than 0.01%): Nausea[Ref]

General

The most commonly reported side effects were discomfort or irritation in the nose, mouth or throat, and sneezing.[Ref]

Nervous system

Very rare (less than 0.01%): Insomnia, nervousness, tremor, anxiety, restlessness, irritability, headache[Ref]

Ocular

Rare (less than 0.1%): Eye irritation, dryness, discomfort/redness[Ref]

Respiratory

Rare (less than 0.1%): Discomfort or irritation in the nose, mouth or throat, sneezing
Frequency not reported: Rhinitis medicamentosa (after prolonged or heavy use)[Ref]

Some side effects of Zicam Sinus Relief may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.