When This Medicine Should Not Be Used:
This medicine is not right for everyone. You should not use it if you had an allergic reaction to phenylephrine or to any other ingredient listed on the product label.

How to Use This Medicine:
Cream

• Follow the instructions on the medicine label if you are using this medicine without a prescription.
• This medicine may be used on the outer anal area, or placed just inside your rectum. Ask your doctor if you are not sure where you should use the medicine.
• Wash your hands with soap and water before and after you use this medicine. When possible, clean your anal area and gently dry the area before you apply the medicine.
• Apply this medicine around your anal area up to 4 times daily. It is best to use this medicine in the morning, after a bowel movement, or before you go to bed.
• To apply the cream inside your rectum, attach the applicator tip to the medicine tube. To make the applicator easier to insert, you may coat it with a lubricating gel such as K-Y® Jelly. Insert the tip gently into your rectum and squeeze the tube to release the cream. Then apply a small amount of cream to the outside of your anal area.
• Wash the applicator with soap and water, and put the protective cap back on.
• Missed dose: Apply a dose as soon as you can. If it is almost time for your next dose, wait until then and apply a regular dose. Do not apply extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how phenylephrine works. Tell your doctor if you are using the following:
  
  • Medicine to lower blood pressure
  • Antidepressants
  • An MAO inhibitor (MAOI)

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding. Also tell him if you have diabetes, heart disease, thyroid disease, high blood pressure, or problems urinating due to an enlarged prostate.
• Ask your doctor before you use this medicine on a child younger than 12 years.
• Call your doctor if your symptoms do not improve within 7 days, or if they get worse.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Bleeding from your rectum
• Pain in your rectum when using the medicine applicator

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088