AfterPill Levonorgestrel LEVONORGESTREL LEVONORGESTREL SILICON DIOXIDE STARCH, CORN LACTOSE MONOHYDRATE MAGNESIUM STEARATE TALC off-white
Drug Facts
Composition & Profile
Identifiers & Packaging
PRINCIPAL DISPLAY PANEL AfterPill TM (levonorgestrel) Tablet , 1.5 mg NDC 64122-604-01 emergency contraceptive Reduces chance of pregnancy after unprotected sex. Not for regular birth control. Contains 1 Tablet 1.5mg Front Panel Back Panel S:\RA\Labeling\Drug Listing\202508-Levonorgestrel OTC\After Pill\SPL Components\front panel.jpg S:\RA\Labeling\Drug Listing\202508-Levonorgestrel OTC\After Pill\SPL Components\back panel.jpg
- PRINCIPAL DISPLAY PANEL AfterPill TM (levonorgestrel) Tablet , 1.5 mg NDC 64122-604-01 emergency contraceptive Reduces chance of pregnancy after unprotected sex. Not for regular birth control. Contains 1 Tablet 1.5mg Front Panel Back Panel S:\RA\Labeling\Drug Listing\202508-Levonorgestrel OTC\After Pill\SPL Components\front panel.jpg S:\RA\Labeling\Drug Listing\202508-Levonorgestrel OTC\After Pill\SPL Components\back panel.jpg
Overview
Indications Use for women 17 years of age and older to reduce chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use birth control)
Indications & Usage
Indications Use for women 17 years of age and older to reduce chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use birth control)
Dosage & Administration
Directions women 17 years of age or older: take tablet as soon as possible within 72 hours (3 days) after unprotected sex. The sooner you take it the better it will work. if you vomit within 2 hours after taking the medication, call a healthcare professional to find out if you should repeat the dose
Warnings & Precautions
Warnings Allergy alert: Do not use if you have ever had an allergic reaction to Levonorgestrel Sexually transmitted diseases (STDs) alert: This product does not protect against HIV/AIDS or other STDs
Purpose
Purpose Emergency contraceptive
Do Not Use
Do not use if you are already pregnant (because it will not work) for regular birth control
When Using
When using this product you may have menstrual changes nausea lower stomach (abdominal) pain tiredness headache dizziness breast pain vomiting
Keep Out of Reach of Children
Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Questions
Questions or comments? For more information, ask your healthcare professional or call 1-855-889-3012 or visit our website at www.afterpill.com AfterPill TM Emergency Contraceptive What You Need to Know What is AfterPill TM ? AfterPill TM is emergency contraception that helps prevent pregnancy after birth control failure or unprotected sex. It is a backup method of preventing pregnancy and should not be used as regular birth control. What AfterPill TM is not. AfterPill TM will not work if you are already pregnant and will not affect an existing pregnancy. AfterPill TM will not protect you from HIV infection (the virus that causes AIDS) and other sexually transmitted diseases (STDs). When should I use AfterPill TM ? The sooner you take emergency contraception, the better it works. You should use AfterPill TM within 72 hours (3 days) after you have had unprotected sex . AfterPill TM is a backup or emergency method of birth control you can use when: Your regular birth control was used incorrectly or failed You did not use any birth control method When not to use AfterPill TM . AfterPill TM should not be used: as a regular birth control method, because it's not as effective as regular birth control. if you are already pregnant, because it will not work. if you are allergic to levonorgestrel or any other ingredients in AfterPill TM . How does AfterPill TM work? AfterPill TM is one tablet with levonorgestrel, a hormone that has been used in many birth control pills for several decades. AfterPill TM contains a higher dose of levonorgestrel than birth control pills, but works in a similar way to prevent pregnancy. It works mainly by stopping the release of an egg from the ovary. It is possible that AfterPill TM may also work by preventing fertilization of an egg (the uniting of sperm with the egg) or by preventing attachment (implantation) to the uterus (womb). How can I get the best results from AfterPill TM ? You have 72 hours (3 days) to try to prevent pregnancy after birth control failure or unprotected sex. The sooner you take AfterPill TM , the better it works. How effective is AfterPill TM ? If AfterPill TM is taken as directed, it can significantly decrease the chance that you will get pregnant. About 7 out of every 8 women who would have gotten pregnant will not become pregnant. How will I know AfterPill TM worked? You will know AfterPill TM has been effective when you get your next period, which should come at the expected time, or within a week of the expected time. If your period is delayed beyond 1 week, it is possible you may be pregnant. You should get a pregnancy test and follow up with your healthcare professional. Will I experience any side effects? Some women may have changes in their period, such as a period that is heavier or lighter or a period that is early or late. If your period is more than a week late, you may be pregnant. If you have severe abdominal pain, you may have an ectopic pregnancy, and should get immediate medical attention. When used as directed, AfterPill TM is safe and effective. Side effects may include changes in your period, nausea, lower stomach (abdominal) pain, tiredness, headache, dizziness, and breast tenderness. If you vomit within 2 hours of taking the medication, call a healthcare professional to find out if you should repeat the dose. What if I still have questions about AfterPill TM ? If you have questions or need more information, call 1-855-889-3012, or visit our website at www.AfterPill.com Other Information Keep out of reach of children: In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Do not use if the folding carton safety seal or tablet blister seal is broken or opened. Store at room temperature 20–25°C (68–77°F). Active ingredient: levonorgestrel 1.5 mg Inactive ingredients: colloidal silicon dioxide, pregelatinized starch, lactose monohydrate, magnesium stearate, and talc If you are sexually active, you should see a healthcare provider for routine checkups. Your healthcare provider will talk to you about and, if necessary, test you for sexually transmitted diseases, teach you about effective methods of routine birth control, and answer any other questions you may have. Manufactured in the USA for: Syzygy Healthcare Solutions, LLC Westport, CT 06880 PI6223003601 Iss. 04/2014
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