12 Hour Nasal Relief Spray 0.05 %

Generic name:
Decongestant spray - nasal

This medication is used for temporary relief of congestion in the nose caused by various conditions including the common cold, sinusitis, hay fever, and allergies. It works by narrowing the blood vessels in the nose area, reducing swelling and congestion.

This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be used to relieve "plugged ears" and to reduce swelling in the nose before certain surgery or procedures.

Use this medication in the nose as directed. Follow all directions on the product package, or use as directed by your doctor. If you have any questions, ask your doctor or pharmacist.

Gently blow your nose before using this drug. Use your finger to close the nostril on the side not receiving the medication. While keeping your head upright, place the spray tip into the open nostril. Spray the medication into the open nostril as you breathe in through your nose. Sniff hard a few times to be sure the medication reaches deep into the nose. Repeat these steps for the other nostril if needed.

Avoid spraying the medication into your eyes or onto the middle of the inside of your nose (nasal septum).

Rinse the spray tip with hot water or wipe with a clean tissue after each use. Make sure that water does not get inside the container. Replace cap after each use.

This medication provides only temporary relief. Do not use more often, use more sprays, or use longer than directed because doing so may increase the risk of side effects. Also, do not use this medication for more than 3 days or it may cause a condition called rebound congestion. Symptoms of rebound congestion include long-term redness and swelling inside the nose and increased runny nose. If this occurs, stop using this medication and consult your doctor or pharmacist.

Tell your doctor if your condition gets worse or lasts after 3 days.

Temporary burning, stinging, dryness in the nose, runny nose, and sneezing may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

If your doctor has prescribed this medication, remember that your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• slow/fast/pounding heartbeat
• dizziness
• nausea
• headache
• mental/mood changes
• trouble sleeping
• shaking (tremors)
• unusual sweating
• unusual weakness

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using this nasal decongestant, tell your doctor or pharmacist if you are allergic to it; or to other sympathomimetics (such as pseudoephedrine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

If you have any of the following health problems, consult your doctor or pharmacist before using this product:

• heart/blood vessel disease
• overactive thyroid (hyperthyroidism)
• diabetes
• high blood pressure
• difficulty urinating (due to enlarged prostate)

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Children may be more sensitive to the side effects of this drug. Check the product package or consult with your doctor or pharmacist about whether this nasal spray can be used by children.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, metaxalone, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication. Ask your doctor when to start or stop taking this medication.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: drowsiness, slow heartbeat, dizziness, fainting.

Do not share this medication with others. Use of this container by more than one person may spread infection.

There are various nasal decongestants available, many without a prescription. Talk with your doctor or pharmacist about which product is best for you.

Not applicable.

Refer to storage information printed on the package. Protect from heat and light. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.