Pronunciation:

fen-il-EF-rin

Brand Names:

• Neo-Synephrine
• Nostril
• Pretz-D
• Rhinall
• Tur-Bi-Cal
• Vicks Sinex

Dosage Forms:

• Solution
• Spray

Classifications:

Therapeutic—

Decongestant

Pharmacologic—

Adrenergic System

Chemical—

Alkylarylamine

Uses of This Medicine:

Phenylephrine is used for the temporary relief of congestion or stuffiness in the nose caused by hay fever or other allergies, colds, or sinus trouble. It may also be used in ear infections to relieve congestion.

This medicine may also be used for other conditions as determined by your doctor.

This medicine is available without a prescription.

Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects .

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Children may be especially sensitive to the effects of nasal phenylephrine. This may increase the chance of side effects during treatment.

Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects .

Older adults—

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of nasal phenylephrine in the elderly with use in other age groups.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Dihydroergotamine
• Linezolid
• Rasagiline
• Selegiline

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Ergonovine
• Fentanyl Citrate
• Iobenguane I 123
• Iobenguane I 131
• Methylergonovine
• Midodrine
• Zavegepant

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Type 2 diabetes mellitus or
• Heart or blood vessel disease or
• High blood pressure or
• Overactive thyroid—Nasal phenylephrine may make the condition worse

Proper Use of This Medicine:

To use the nose drops:

• Blow your nose gently. Tilt the head back while standing or sitting up, or lie down on a bed and hang head over the side. Place the drops into each nostril and keep the head tilted back for a few minutes to allow the medicine to spread throughout the nose.
• Rinse the dropper with hot water and dry with a clean tissue. Replace the cap right after use.
• To avoid spreading the infection, do not use the container for more than one person.

To use the nose spray:

• Blow your nose gently. With the head upright, spray the medicine into each nostril. Sniff briskly while squeezing the bottle quickly and firmly. For best results, spray once or twice into each nostril and wait 3 to 5 minutes to allow the medicine to work. Then, blow your nose gently and thoroughly. Repeat until the complete dose is used.
• Rinse the tip of the spray bottle with hot water, taking care not to suck water into the bottle, and dry with a clean tissue. Replace the cap right after use.
• To avoid spreading the infection, do not use the container for more than one person.

To use the nose jelly:

• Blow your nose gently. Wash your hands before applying the medicine. With your finger, place a small amount of jelly (about the size of a pea) up each nostril. Sniff it well back into the nose.
• Wipe the tip of the tube with a clean, damp tissue and replace the cap right after use.

Use this medicine only as directed. Do not use more of it, do not use it more often, and do not use it for longer than 3 days without first checking with your doctor. To do so may make your runny or stuffy nose worse and may also increase the chance of side effects.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For stuffy nose:
  • For nose jelly dosage form:
    • Adults—Use a small amount in the nose every three or four hours as needed.
    • Children—Use is not recommended.
  • For nose drops dosage form:
    • Adults and children 12 years of age and older—Use two or three drops of a 0.25 to 0.5% solution in the nose every four hours as needed.
    • Children 6 to 12 years of age—Use two or three drops of a 0.25% solution in the nose every four hours as needed.
    • Children 4 to 6 years of age—Use two or three drops of a 0.125 or 0.16% solution in the nose every four hours as needed.
    • Children and infants up to 4 years of age—Use is not recommended .
  • For nose spray dosage form:
    • Adults and children 12 years of age and older—Use two or three sprays of a 0.25 to 0.5% solution in the nose every four hours as needed.
    • Children 6 to 12 years of age—Use two or three sprays of a 0.25% solution in the nose every four hours as needed.
    • Children 4 to 6 years of age—Use and dose must be determined by your doctor.
    • Children and infants up to 4 years of age—Use is not recommended .

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Increase in runny or stuffy nose

Symptoms of too much medicine being absorbed into the body

Fast, irregular, or pounding heartbeat

headache or dizziness

increased sweating

nervousness

paleness

trembling

trouble in sleeping

Note: The above side effects are more likely to occur in children because there is a greater chance that too much of this medicine may be absorbed into the body.

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Burning, dryness, or stinging of inside of nose

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.