Formulation R (rectal)

Formulation R is a decongestant that reduces the size of blood vessels. Enlarged blood vessels can lead to hemorrhoids.

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

Formulation R may also be used for other reasons not mentioned in this medication guide.

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.

Follow all the instructions on your medicine label and package. Inform all your healthcare providers about your medical conditions, allergies, and all the medicines you are using.

You should not use Formulation R if you are allergic to it. Formulation R is often found 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.

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

Formulation R may cause serious side effects. Stop using Formulation R and call your doctor right away 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 common, and you may not experience any 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 the FDA at 1-800-FDA-1088.

Since Formulation R rectal is used when needed, you probably won't 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 have ingredients similar to Formulation R (rectal).

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.