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NDC 69953-0515-01 Morning After 1.5 mg/1.5mg Details
Morning After 1.5 mg/1.5mg
Morning After is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Rapha Pharmaceuticals, Inc.. The primary component is LEVONORGESTREL.
MedlinePlus Drug Summary
Levonorgestrel is used to prevent pregnancy after unprotected sexual intercourse (sex without any method of birth control or with a birth control method that failed or was not used properly [e.g., a condom that slipped or broke or birth control pills that were not taken as scheduled]). Levonorgestrel should not be used to prevent pregnancy on a regular basis. This medication is to be used as an emergency contraceptive or backup in case regular birth control fails or is used incorrectly. Levonorgestrel is in a class of medications called progestins. It works by preventing the release of an egg from the ovary or preventing fertilization of the egg by sperm (male reproductive cells). It also may work by changing the lining of the uterus (womb) to prevent development of a pregnancy. Levonorgestrel may prevent pregnancy, but it will not prevent the spread of human immunodeficiency virus (HIV, the virus that causes acquired immunodeficiency syndrome [AIDS]) and other sexually transmitted diseases.
Related Packages: 69953-0515-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Levonorgestrel
Product Information
| NDC | 69953-0515 |
|---|---|
| Product ID | 69953-515_677aa953-3c31-4ce5-e053-2991aa0ab2b2 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Morning After |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Levonorgestrel |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 1.5 |
| Active Ingredient Units | mg/1.5mg |
| Substance Name | LEVONORGESTREL |
| Labeler Name | Rapha Pharmaceuticals, Inc. |
| Pharmaceutical Class | Inhibit Ovum Fertilization [PE], Progesterone Congeners [CS], Progesterone Congeners [CS], Progestin [EPC], Progestin-containing Intrauterine Device [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA206867 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 69953-0515-01 (69953051501)
| NDC Package Code | 69953-515-01 |
|---|---|
| Billing NDC | 69953051501 |
| Package | 1 BLISTER PACK in 1 CARTON (69953-515-01) / 1 mg in 1 BLISTER PACK |
| Marketing Start Date | 2018-03-22 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 677aa953-3c30-4ce5-e053-2991aa0ab2b2 Details
USE
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
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
taking efavirenz (HIV medication) or rifampin (tuberculosis treatment) or medication for seizures (epilepsy). These medications may reduce the effectiveness of levonorgestrel.
DIRECTIONS
OTHER INFORMATION
- read the instructions, warnings and enclosed product leaflet before use
- this product works mainly by preventing ovulation (egg release). It may also prevent fertilization of a released egg (joining of sperm and egg) or attachment of a fertilized egg to the uterus (implantation).
- do not use if carton is open or tear strip is removed or the blister seal is broken or missing
- store at 20° to 25°C (68° to 77°F)
INACTIVE INGREDIENTS
QUESTIONS?
PATIENT INFORMATION
Morning After®
(levonorgestrel tablet, 1.5 mg)
Emergency Contraceptive
One Tablet. One Step.
What You Need to Know
What is Morning After®?
Morning After® 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 Morning After® is not.
Morning After® will not work if you are already pregnant and will not affect an existing pregnancy. Morning After® will not protect you from HIV infection (the virus that causes AIDS) and other sexually transmitted diseases (STDs).
When should I use Morning After®?
The sooner you take emergency contraception, the better it works. You should use Morning After® within 72 hours (3 days)
after you have had unprotected sex.
Morning After® 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 Morning After®.
Morning After® 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 Morning After®.
When should I talk to a doctor or pharmacist?
Ask a doctor or pharmacist before use if you are taking efavirenz (HIV medication) or rifampin (tuberculosis treatment) or medication for seizures (epilepsy). These medications may reduce the effectiveness of Morning After® and increase your chance of becoming pregnant. Your doctor may prescribe another form of emergency contraception that may not be affected by these medications.
How does Morning After® work?
Morning After® is one tablet with levonorgestrel, a hormone that has been used in many birth control pills for several decades. Morning After® 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 Morning After® 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 Morning After®?
You have 72 hours (3 days) to try to prevent pregnancy after birth control failure or unprotected sex.
The sooner you take Morning After®, the better it works.
How effective is Morning After®?
If Morning After® 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 Morning After® worked?
You will know Morning After® 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, Morning After® 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 Morning After®?
If you have questions or need more information, call our toll-free number at 1-855-274-4122.
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 blister seal is opened.
Store at room temperature 20° to 25°C (68° to 77°F).
Active ingredient: levonorgestrel 1.5 mg
Inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, potato starch, 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 for:
Rapha Pharmaceuticals, Inc.
Orlando, Florida 32819 USA
Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 038, India
Revised: 02/2018
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1.5 MG (1 TABLET CARTON LABEL)
NDC 69953-515-01
Morning After®
(levonorgestrel tablet 1.5 mg)
Emergency Contraceptive
Reduces chance of pregnancy after unprotected sex.
Contains 1 Tablet Levonorgestrel 1.5 mg
Not for regular birth control.
One Tablet.
One Step.
The sooner you take it, the more effective it will be
Take as soon as possible within 72 hours (3 days)
after unprotected sex
Will not harm an existing pregnancy
New! Now Available Over The Counter
INGREDIENTS AND APPEARANCE
| MORNING AFTER
levonorgestrel tablet |
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| Labeler - Rapha Pharmaceuticals, Inc. (079804155) |