Uses

This product contains 3 medications, a decongestant and 2 antibiotics. Phenylephrine is a decongestant that is used for temporary relief of stuffy nose caused by various conditions, including the common cold, sinusitis, hay fever, allergies, nasal or sinus surgery. It works by narrowing the blood vessels in the nose area. This effect reduces swelling/stuffiness and dries up mucus. It temporarily helps you breathe better through your nose.

This medication also contains framycetin (also known as neomycin B) and gramicidin, antibiotics that work by stopping the growth of bacteria.

Antibiotics treat only bacterial infections. They will not work for viral infections (such as common cold, flu). Bacterial infections of the nose or sinus may need to be treated with a different medication taken by mouth. Using any antibiotic when it is not needed can cause it to not work for future infections.

This medication has also been used as part of an infection control program to temporarily get rid of certain bacteria found in the nose (Staphylococcus, also known as staph).

This medication should not be used by children younger than 2 years.

How To Use

Gently blow your nose before using this drug. Use this product as directed by your doctor, usually 2 sprays in each nostril every 4 hours (for treating an infection or stuffy nose) or 2 sprays in each nostril twice daily (for reducing staph bacteria in the nose). Do not use this medication more than 6 times in 24 hours. Your dosage is based on your medical condition and response to treatment.

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 this medication more often, use more sprays, or use it longer than directed because doing so may increase the risk of side effects. Also, do not use this medication for longer than 3 to 5 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.

Side Effects

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

Remember that this medication has been prescribed because 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
• feeling of spinning (vertigo)
• severe/pounding headache
• hearing problems (such as ringing in the ears, hearing loss)
• loss of balance
• mental/mood changes (such as nervousness)
• trouble sleeping
• blurred vision

Use of this medication for prolonged or repeated periods may result in a new fungal infection (such as thrush). Do not use this medication for longer than prescribed. Contact your doctor if you notice white patches in your mouth or other new symptoms.

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.

Precautions

Before using this medication, tell your doctor or pharmacist if you are allergic to framycetin or other aminoglycoside antibiotics (such as neomycin, gentamicin); or to gramicidin; or to phenylephrine or 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.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• narrow-angle glaucoma
• severe dry nose (rhinitis sicca)
• diabetes
• heart/blood vessel disease (such as chest pain, stroke, heart attack)
• high blood pressure
• overactive thyroid (hyperthyroidism)

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

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 breast-feeding.

Drug Interactions

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.

Overdose

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 their local poison control center at 1-800-222-1222. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center. Symptoms of overdose may include: drowsiness, slow heartbeat, fainting.

Notes

Do not share this medication with others.

Missed Dose

If you are using this medication on a regular schedule and miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

Storage

Store at room temperature. 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.