PLEASE READ AND REVIEW THE FOLLOWING TERMS OF USE CAREFULLY BEFORE USING THIS WEB SITE OPERATED BY DANCO LABORATORIES, LLC.

These Terms of Use describe the terms and conditions applicable to your use of this Web site (“the Site”), owned and operated by Danco Laboratories, LLC (“Danco,” “we,” “our,” or “us”). By accessing or using the Site, you agree, without limitation or qualification, to these Terms of Use. Please read these Terms of Use carefully before accessing or using the Site. By accessing or using the Site, you acknowledge that you have read, understood and agree to be bound by the Terms of Use set forth below. If you are not willing to be bound by these Terms of Use, you should not access the Site. If you do not agree, please exit and disregard the information contained herein. So long as you comply with the Terms of Use, Danco grants you a personal, non-exclusive, non-transferable, limited privilege to enter and use the Site.

1. Revisions.

Danco may change these Terms in whole or in part, at any time and from time to time, by updating these Terms of Use. The modified terms are effective immediately upon posting, and you will be bound by any such modifications. You may view the current applicable version of the Terms of Use through a link at the bottom of each page within this Site.

2. Medical Information.

Information on this Site related to our product, or to certain medical conditions is intended for purposes of general information only. If you have a medical condition, promptly see your physician or health care provider. We do not offer personalized medical diagnosis or patient-specific treatment advice. Indeed, only your doctor or other health care professional, as a learned intermediary, can determine if a product described in this, or any, Web site is appropriate for you. YOU SHOULD CONSULT WITH YOUR DOCTOR, OR OTHER QUALIFIED HEALTH CARE PROFESSIONAL BEFORE USING ANY PRODUCT DISCUSSED WITHIN THIS, OR ANY OTHER, WEB SITE.

3. Use of the Site.

You may freely browse the Site, but you may only access, download, copy, reproduce, republish, upload, post, publicly display, translate, transmit, distribute, or otherwise use information from this Site, including any text, images, user interfaces, photographs, trademarks, logos, and computer code or other materials (collectively, “Content”) for any non-commercial use, or for any purpose by health care providers, clinics, hospitals, offices, and other locations at which health care is provided; and those in association with them. All Content is owned, controlled, or licensed by Danco and is protected by trade dress, copyright, patent, trademark, and various other federal and international intellectual property rights and laws. You may not use Content for any other purpose without the express written consent of Danco. All Content should be assumed to be copyrighted unless otherwise noted and may not be used except as provided in these Terms of Use or in the text of this Site without the prior written permission of Danco.

Some of the Content may be downloadable for your personal, non-commercial use, consistent with these Terms. You may use such Content purposely made available by Danco for downloading form the site provided that you (1) not remove any proprietary notice language, logos, trademarks, or other Danco marks from the documents; (2) use such Content only for your personal, non-commercial use; (3) make no modifications to such Content; and (4) not make any additional representations or warranties relating to such Content.

You agree not to attempt to gain unauthorized access to any portion or feature of the Site, or any systems or networks connected to the Site or any Danco server. You further agree not to (i) scan or test the vulnerability of the Site or any network connected to the Site; (ii) breach the security or authentication measures on the Site or any network connected to the Site; or (iii) exploit the Site or any service or information made available or offered through the Site for personal or commercial gain.

You agree not to use the Site for any purpose that is unlawful or prohibited by these Terms of Use.

4. Privacy.

Please refer to Danco’s Internet Privacy Policy for information about the submission of personally identifiable information using this Site. Danco’s Internet Privacy Policy is a part of these Terms of Use and incorporated herein by this reference. By accepting these Terms of Use, you agree to the collection and use of your information as described in the Internet Privacy Policy.

5. Links to Other Web sites.

This Site contains links to other Internet Web sites which are not maintained by Danco. These links are provided solely for the convenience of our users. Other Web sites may have privacy policies and/or terms or use that are different from Danco’s. Danco is not responsible for the content of or access to any such Web sites or for the breach of any such site’s privacy policy.

Inclusion on this Site of any link to another Web site, or any reference to a non-Danco product or service does not constitute an endorsement or recommendation by Danco. Access to other sites linked to this Site is at your own risk, and Danco disclaims all liability with regard to your access to or use of such linked sites.

6. Disclaimer of Warranties.

Danco has taken reasonable measures to ensure that the Site and all materials and information included in or available through the Site are reliable; however, Danco, makes no express or implied warranty regarding the accuracy, content, completeness, reliability, operability, or legality of information contained within this Site, including, without limitation, the warranties of merchantability, fitness for a particular purpose, and non-infringement of proprietary rights. Danco assumes no liability or responsibility for any errors or omissions in the content of the Site. ALL INFORMATION IS PROVIDED “AS IS”; DANCO PROVIDES NO WARRANTY AS TO THE COMPLETENESS OR ACCURACY OF THE INFORMATION ON THIS SITE OR ITS POSSIBLE USES. CONSEQUENTLY, THE INFORMATION SHOULD BE CAREFULLY EVALUATED BY SITE USERS. NEITHER DANCO, NOR ANY OTHER PARTY INVOLVED IN CREATING, PRODUCING OR DELIVERING THIS SITE TO YOU SHALL BE LIABLE FOR ANY DIRECT, INCIDENTAL, CONSEQUENTIAL, INDIRECT OR PUNITIVE DAMAGES ARISING OUT OF ACCESS TO, USE OF OR INABILITY TO USE THIS SITE, OR ANY ERRORS OR OMISSIONS IN THE CONTENT OF THE SITE. Some jurisdictions do not allow the exclusion of implied warranties, so the above exclusion may not apply to you. Danco also assumes no responsibility, and shall not be liable for, any damages to, or viruses that may infect your computer equipment or other property as a result of your access to this Site.

WE WILL NOT BE LIABLE TO YOU FOR ANY LOST PROFITS OR OTHER CONSEQUENTIAL, SPECIAL, INDIRECT, OR INCIDENTAL DAMAGES ARISING OUT OF OR IN CONNECTION WITH THIS AGREEMENT OR DANCO, EVEN IF WE HAVE BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. OUR AGGREGATE LIABILITY ARISING OUT OF THIS AGREEMENT WILL NOT EXCEED THE GREATER OF ONE HUNDRED DOLLARS ($100) OR THE AMOUNT YOU HAVE PAID US IN THE PAST TWELVE MONTHS. APPLICABLE LAW MAY NOT ALLOW THE LIMITATION OR EXCLUSION OF LIABILITY OR INCIDENTAL OR CONSEQUENTIAL DAMAGES, SO THE ABOVE LIMITATION OR EXCLUSION MAY NOT APPLY TO YOU. IN SUCH CASES, DANCO’S LIABILITY WILL BE LIMITED TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW.

7. Indemnification/Consequences.

Danco may suspend or terminate your access to the Site at any time and without notice.

You agree to indemnify, defend and hold harmless Danco, its officers, directors, employees, agents, suppliers, and third party partners from and against all liabilities, claims, losses, expenses, damages and costs, including reasonable attorneys’ fees, resulting from any violation by you of these Terms of Use.

8. General Provisions.

These Terms of Use, together with our Privacy Policy, constitute the entire agreement between you and Danco with respect to use of this Site. These Terms of Use may not be modified or amended by you without the prior written consent of Danco. Danco may modify or amend these Terms of Use and the Internet Privacy Policy at any time without notice to you. If any provision of these Terms of Use is found to be invalid or unenforceable, the remaining provisions shall remain in full force and effect. These Terms of Use and your use of the Site shall be governed by the laws of the United States of America and the State of New York without regard to its conflicts of laws principles and you waive any objection to such jurisdiction and venue. Any claim under these Terms of Use must be brought within one (1) year after the cause of action arises, or such claim or cause of action is barred. The headings used in these Terms of Use are for convenience only and such headings are not to be used in determining the meaning or interpretation of these Terms of Use.

Important Safety Information

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

What symptoms should I be concerned with?

Although cramping and bleeding are an expected part of ending a pregnancy, rarely, serious and potentially life-threatening bleeding, infections, or other problems can occur following a miscarriage, surgical abortion, medical abortion, or childbirth. Seeking medical attention as soon as possible is needed in these circumstances. Serious infection has resulted in death in a very small number of cases. There is no information that use of Mifeprex and misoprostol caused these deaths. If you have any questions, concerns, or problems, or if you are worried about any side effects or symptoms, you should contact your healthcare provider. Please see additional Important Safety Information and the Medication Guide.

Be sure to contact your healthcare provider promptly if you have any of the following:

Heavy Bleeding. Contact your healthcare provider right away if you bleed enough to soak through two thick full-size sanitary pads per hour for two consecutive hours or if you are concerned about heavy bleeding. In about 1 out of 100 women, bleeding can be so heavy that it requires a surgical procedure (surgical aspiration or D&C).
Abdominal Pain or “Feeling Sick.” If you have abdominal pain or discomfort, or you are “feeling sick,” including weakness, nausea, vomiting, or diarrhea, with or without fever, more than 24 hours after taking misoprostol, you should contact your healthcare provider without delay. These symptoms may be a sign of a serious infection or another problem (including an ectopic pregnancy, a pregnancy outside the womb).
Fever. In the days after treatment, if you have a fever of 100.4°F or higher that lasts for more than 4 hours, you should contact your healthcare provider right away. Fever may be a symptom of a serious infection or another problem.

If you cannot reach your healthcare provider, go to the nearest hospital emergency room. Take the Medication Guide (PDF)(link to Medication Guide) with you. When you visit an emergency room or a healthcare provider who did not give you your Mifeprex, you should give them your Medication Guide so that they understand that you are having a medical abortion with Mifeprex.

What to do if you are still pregnant after Mifeprex with misoprostol treatment. If you are still pregnant, your healthcare provider will talk with you about a surgical procedure to end your pregnancy. In many cases, this surgical procedure can be done in the office/clinic. The chance of birth defects if the pregnancy is not ended is unknown.

Talk with your healthcare provider.

Before you take Mifeprex, you should read the Medication Guide (PDF) and you and your healthcare provider should discuss the benefits and risks of your using Mifeprex.

What is Mifeprex?

Mifeprex is used in a regimen with another prescription medicine called misoprostol, to end an early pregnancy. Early pregnancy means it is 70 days (10 weeks) or less since your last menstrual period began. Mifeprex is not approved for ending pregnancies that are further along. Mifeprex blocks a hormone needed for your pregnancy to continue.

When you use Mifeprex on Day 1, you also need to take another medication called misoprostol 24 to 48 hours after you take Mifeprex, to cause the pregnancy to be passed from your uterus.

The pregnancy is likely to be passed from your uterus within 2 to 24 hours after taking Mifeprex and misoprostol. When the pregnancy is passed from the uterus, you will have bleeding and cramping that will likely be heavier than your usual period. About 2 to 7 out of 100 women taking Mifeprex will need a surgical procedure because the pregnancy did not completely pass from the uterus or to stop bleeding.

Who should not take Mifeprex?

Some women should not take Mifeprex. Do not take Mifeprex if you:

Have a pregnancy that is more than 70 days (10 weeks).
Are using an IUD (intrauterine device or system) (must be taken out before you take Mifeprex).
Have been told by your healthcare provider you have a pregnancy outside the uterus (ectopic pregnancy).
Have problems with your adrenal glands.
Take medicine to thin your blood.
Have a bleeding problem.
Have porphyria.
Take certain steroid medicines.
Are allergic to mifepristone, misoprostol or other prostaglandins.

Mifeprex cannot be used in cases of confirmed or suspected ectopic pregnancy as MIFEPREX is not effective for terminating those pregnancies. If you are using an IUD, it must be taken out before you take Mifeprex.

What are the possible side effects of Mifeprex and misoprostol?

Mifeprex may cause serious side effects. See “What is the most important information I should know about Mifeprex?” above.

Cramping and Bleeding. Cramping and vaginal bleeding are expected with this treatment. Usually, these symptoms mean that the treatment is working. But sometimes you can get cramping and bleeding and still be pregnant. This is why you must follow-up with your healthcare provider approximately 7 to 14 days after taking Mifeprex. See “How should I take Mifeprex?” in the Medication Guide (PDF) (link to Medication Guide) for more information on your follow-up assessment. If you are not already bleeding after taking Mifeprex, you probably will begin to bleed once you take misoprostol, the medicine you take 24 to 48 hours after Mifeprex. Bleeding or spotting can be expected for an average of 9 to16 days and may last for up to 30 days. Your bleeding may be similar to, or greater than, a normal heavy period. You may see blood clots and tissue. This is an expected part of passing the pregnancy.

The most common side effects of Mifeprex treatment include: nausea, weakness, fever/chills, vomiting, headache, diarrhea and dizziness. Your provider will tell you how to manage any pain or other side effects. These are not all the possible side effects of Mifeprex.

Call your healthcare provider for medical advice about any side effects that bother you or do not go away. You may report side effects to FDA at 1-800-FDA-1088.

General Information about the safe and effective use of Mifeprex.

Medicines are sometimes prescribed for purposes other than those listed in the Medication Guide (PDF). The Medication Guide summarizes the most important information about Mifeprex. If you would like more information, talk with your healthcare provider. If you would like information about Mifeprex that is written for healthcare professionals you may download the Mifeprex Prescribing Information (PDF).