When This Medicine Should Not Be Used:
You should not use this medicine if you have had an allergic reaction to nonoxynol 9 or to sulfites. Do not use this medicine within the first 6 weeks after giving birth, or during your menstrual period. You should not use this medicine if you have had Toxic Shock Syndrome (TSS).

How to Use This Medicine:
Gel/Jelly, Sponge, Suppository

• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Wash your hands with soap and water before and after using this medicine.
• This medicine is to be used only in the vagina. Do not use this medicine on your rectum.
• To use the vaginal gel:
  
  • This medicine comes with a disposable plastic applicator. You will need to use the applicator each time you use the medicine. Do not use the medicine without the applicator.
  • Use a new gel if sexual intercourse has not taken place within one hour after insertion, or each time intercourse is repeated.
• To use the vaginal sponge:
  
  • The sponge begins protection right away and lasts for 24 hours even with repeated sexual intercourse. Wait at least 6 hours after the last sexual intercourse before removing the sponge.
  • Do not leave sponge inside the vagina for longer than 30 hours. You will need to get all parts of the sponge out of the vagina to decrease the risk of infection.
• To use the vaginal suppository:
  
  • Wait 10 minutes after insertion before having sexual intercourse to assure birth control protection.
  • Use a new suppository if sexual intercourse has not taken place within one hour after insertion, or each time intercourse is repeated.

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

• Avoid using douches or other vaginal products unless your doctor tells you to.

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have given birth before, had a miscarriage or abortion, or if you have been told that you should not become pregnant. Also tell your doctor if you have problems with your vagina or uterus which may keep the product from working.
• Some women using barrier methods of birth control, such as sponge, have developed a rare but serious disease known as Toxic Shock Syndrome. If you start having fever, nausea, vomiting, diarrhea, dizziness, faintness, muscle pain, or a sunburn-like rash on your face or body while using this medicine, remove the sponge and call your doctor right away.
• You may still need to use another form of birth control, such as condom or diaphragm, for added protection against pregnancy. This medicine is not as effective as the pill or IUD. Ask your doctor about this.
• If you have signs of pregnancy such as a late menstrual period, ask your doctor before using this medicine.
• This medicine will not protect you from getting HIV or AIDS, or other sexually transmitted diseases. If this is a concern for you, talk with your doctor.
• Do not use this medicine if you or your sex partner has HIV or AIDS. This medicine can irritate the vagina and rectum, which may increase the risk of getting HIV or AIDS.

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
• Fever or chills.
• Lightheadedness, dizziness, or fainting.
• Muscle pain.
• Nausea, vomiting, diarrhea, or stomach pain.
• Sunburn-like rash on face or body.
• Trouble or pain on urinating.
• Vaginal burning, itching, rash, or discharge.

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