Lactic acid; Citric acid; Potassium bitartrate vaginal gel

What is this medication?

LACTIC ACID; CITRIC ACID; POTASSIUM BITARTRATE (LAK tuhk AS id; SIH trik AS id; poe TASS ee um bi TAAR treit) is used for birth control when you have sexual intercourse to help prevent pregnancy.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): PHEXXI

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• frequent kidney or urinary tract infections
• HIV or AIDS
• pelvic or vaginal infection
• sexually transmitted disease, like herpes, gonorrhea, or chlamydia
• an unusual or allergic reaction to lactic acid, citric acid, potassium bitartrate, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

This medicine is for use in the vagina only. Follow the directions on the prescription label. Wash hands before and after use. To prevent pregnancy, it is very important that this product is used properly. This product must be applied before sexual contact begins. Do not use it in the rectum. Make sure you carefully read and follow the instructions that come with the product. If you have vaginal sex more than 1 time within 1 hour, you must use a new applicator. Use exactly as directed.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

Use before each time you have sexual intercourse as directed on the label. If you miss a dose, you may become pregnant.

What may interact with this medication?

Interactions are not expected. This birth control may be used with other medicines used in the vagina to treat infections including miconazole, metronidazole, and tioconazole. If you have questions ask your doctor or pharmacist. Do not use any other vaginal products at the same time without talking to your health care professional.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

This product does not protect you against HIV infection (AIDS) or other sexually transmitted diseases.

This product may be used at any time of your menstrual cycle. This product may be used as soon as your healthcare provider tells you it is safe for you to have sex after childbirth, abortion, or miscarriage.

This product may be used with most hormonal birth control methods; a vaginal diaphragm; or latex, polyurethane and polyisoprene condoms. Avoid using this product with contraceptive vaginal rings.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling
• signs and symptoms of infection like fever; chills; pelvic pain; cloudy urine; pain or trouble passing urine
• vaginal discharge, itching or odor
• vaginal irritation or burning

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• mild vaginal irritation

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Keep in the foil pouch until ready for use. Follow the directions on the product label. Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.