Formulation R is a decongestant that shrinks blood vessels. Dilated blood vessels can cause hemorrhoids.

Formulation R is used on the rectum to relieve itching, burning, irritation, and swelling caused by hemorrhoids.

Formulation R may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Use exactly as directed on the label, or as prescribed by your doctor.

You may use Formulation R up to 4 times daily, especially after a bowel movement.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Do not place Formulation R cream, gel, or ointment inside your rectum. These forms of phenylephrine rectal are for use only on the area around and just outside of your rectum.

Only the rectal suppository should be placed into the rectum.

Call your doctor if your symptoms do not improve after 7 days, or if they get worse.

Store at room temperature away from moisture and heat.

You should not use Formulation R if you are allergic to it Formulation R (often used in certain cold or allergy medicines).

Ask a doctor or pharmacist if it is safe for you to use this medicine if you have:

• heart disease;

• high blood pressure;

• enlarged prostate or urination problems;

• diabetes; or

• a thyroid disorder.

Ask a doctor before using this medicine if you are pregnant or breast-feeding.

Always ask a doctor before using Formulation R on a child. Do not give this medicine to a child younger than 2 years old.

Since Formulation R rectal is used on an as needed basis, you are not likely to miss a dose. Do not use Formulation R more than 4 times per day.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not take Formulation R rectal suppository by mouth. It is for use only in your rectum.

Ask a doctor or pharmacist before using over-the-counter medicines that may contain ingredients similar to Formulation R.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Formulation R may cause serious side effects. Stop using Formulation R and call your doctor at once if you have:

• rectal bleeding;

• severe irritation inside or around your rectum; or

• increased blood pressure--severe headache, blurred vision, pounding in your neck or ears, anxiety, nosebleed.

Less serious side effects are more likely, and you may have none at all.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Ask a doctor or pharmacist before using Formulation R with any other medications, especially:

• blood pressure medication; or

• an MAO inhibitor--isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

This list is not complete. Other drugs may affect Formulation R, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.