Citric acid, lactic acid, and potassium bitartrate

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

You must use Phexxi before having sex. Phexxi is not a "morning-after" birth control.

You can use Phexxi along with other methods of birth control (like a condom, diaphragm, birth control pills, patches, inserts, implants, or injections).

Do not use Phexxi with a vaginal ring.

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

Use Phexxi before having vaginal sex. Phexxi will not work if you use it after having sex.

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.

Store Phexxi in the foil pouch at room temperature, away from moisture and heat. Use right away after opening the pouch.

Follow all instructions on the product label and package. Inform each of your healthcare providers about all your medical conditions, allergies, and all medicines you are taking.

Do not use Phexxi if you are already pregnant.

You should not use Phexxi if you have a history of frequent bladder infections or other problems with your urinary tract.

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 diseases.

It may not be safe to breastfeed while using Phexxi. Ask your doctor about any risk.

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

Phexxi may cause a bladder or kidney infection. Call your doctor right away if you have:

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

Stop using Phexxi if it causes severe irritation in or around your vagina.

Common side effects of citric acid, lactic acid, and potassium bitartrate 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 continue 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.

Usual Adult Dose for Contraception:

1 prefilled applicatorful vaginally immediately before (or up to 1 hour before) each episode of vaginal intercourse.Comments:-This product is not effective if administered after intercourse.-May use at any point in the menstrual cycle.-An additional dose must be given if more than one act of vaginal intercourse occurs within one hour.-May use as soon as it is safe to have vaginal intercourse after childbirth, abortion, or miscarriage.-May use concomitantly with hormonal contraceptives, condoms (latex, polyurethane, and polyisoprene), and vaginal diaphragms; avoid use with vaginal rings.-May use concomitantly with vaginal infection treatments including miconazole, metronidazole, and tioconazole.Use: On-demand contraception in females of reproductive potential

Since Phexxi is used as 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.

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

Follow your doctor's instructions about any restrictions on food, drinks, or activities.

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