citric acid, lactic acid, and potassium bitartrate

What is the most important information I should know about Phexxi?

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

What is Phexxi (citric acid, lactic acid, and potassium bitartrate)?

Phexxi is a combination medicine used to prevent pregnancy. Phexxi is an on-demand method of birth control that does not contain hormones.

Phexxi must be used before sexual activity. Phexxi is not a "morning-after" birth control.

Phexxi may be used in combination with other methods of birth control (including a condom, diaphragm, birth control pills, patches, inserts, implants, or injections).

Avoid using Phexxi in combination with a vaginal ring.

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

What should I discuss with my healthcare provider before using Phexxi?

Tell your doctor if you've ever had an allergic reaction to any product that contains citric acid, lactic acid, potassium bitartrate, glycerin, xanthan gum, alginic acid, sodium hydroxide, or benzoic acid.

Tell your doctor if you recently had an abortion or miscarriage, or if you recently gave birth to a baby. Your doctor will tell you when it is safe to use Phexxi after any of these events.

Phexxi will not protect you from HIV or other sexually transmitted disease.

How should I use Phexxi?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use Phexxi exactly as directed. You may get pregnant if you do not carefully follow all instructions for use.

Phexxi may be used at any time during your menstrual cycle.

Phexxi is a vaginal gel provided in a prefilled vaginal applicator. Each applicator is for one use only. Insert the gel into your vagina within 1 hour before you have sex.

If you have sex more than once in a 1-hour period, you must insert another dose.

Phexxi may be used in combination with other methods of birth control (including a condom, diaphragm, or birth control pills, patches, inserts, implants, or injections).

Do not use Phexxi in combination with a vaginal ring.

What happens if I miss a dose?

Since Phexxi is used when needed, it does not have a regular dosing schedule.

If you do not have sex within 1 hour after inserting the gel, you must insert another dose.

What happens if I overdose?

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

What should I avoid while using Phexxi?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of Phexxi?

• pain or burning when you urinate;
• urine that looks cloudy; or
• pain in your flank, side, or lower back.

Common side effects may include:

• a bladder infection;
• vaginal burning, itching, or discomfort;
• vaginal itching or discharge; or
• bacterial or fungal infection in the vagina.

If you need to use any vaginal medication to treat a vaginal infection, you may keep using Phexxi.

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.

What other drugs will affect Phexxi?

Other drugs may affect citric acid, lactic acid, and potassium bitartrate, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about citric acid, lactic acid, and potassium bitartrate.