Label: POSTDAY ONE-STEP- levonorgestrel tablet
- NDC Code(s): 69953-617-42, 69953-618-43, 69953-628-60
- Packager: Rapha Pharmaceuticals, Inc.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated November 21, 2023
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- DRUG FACTS
- 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 STDsASK 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 package is open or blister seal is broken or missing
- store levonorgestrel tablets 1.5 mg at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]
- INACTIVE INGREDIENTS
- QUESTIONS?
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PATIENT INFORMATION
Levonorgestrel Tablet, 1.5 mg
Emergency Contraceptive
One Tablet. One Step.
What You Need to Know
What is Levonorgestrel Tablets 1.5 mg?
Levonorgestrel tablets 1.5 mg 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 Levonorgestrel Tablets 1.5 mg is not.
Levonorgestrel tablets 1.5 mg will not work if you are already pregnant and will not affect an existing pregnancy. Levonorgestrel tablets 1.5 mg will not protect you from HIV infection (the virus that causes AIDS) and other sexually transmitted diseases (STDs).
When should I use Levonorgestrel Tablets 1.5 mg?
The sooner you take emergency contraception, the better it works. You should use Levonorgestrel tablets 1.5 mg within 72 hours (3 days) after you have had unprotected sex.
Levonorgestrel Tablets 1.5 mg 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 Levonorgestrel Tablets 1.5 mg
Levonorgestrel Tablets 1.5 mg 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 Levonorgestrel tablets 1.5 mg.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 Levonorgestrel tablets 1.5 mg 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 Levonorgestrel Tablets 1.5 mg work?
Levonorgestrel Tablets 1.5 mg is one tablet with levonorgestrel, a hormone that has been used in many birth control pills for several decades. Levonorgestrel Tablets 1.5 mg 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 Levonorgestrel Tablets 1.5 mg 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 Levonorgestrel Tablets 1.5 mg?
You have 72 hours (3 days) to try to prevent pregnancy after birth control failure or unprotected sex. The sooner you take Levonorgestrel Tablets 1.5 mg, the better it works.How effective is Levonorgestrel Tablets 1.5 mg?
If Levonorgestrel Tablets 1.5 mg 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 Levonorgestrel Tablets 1.5 mg worked?
You will know Levonorgestrel Tablets 1.5 mg 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, Levonorgestrel Tablets 1.5 mg 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 Levonorgestrel Tablets 1.5 mg?
If you have questions or need more information, call our toll-free number at 1-855-288-4717Other 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 levonorgestrel tablets 1.5 mg at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Active ingredient: levonorgestrel 1.5 mg
Inactive ingredients: cellulose microcrystalline, croscarmellose sodium, lactose monohydrate, magnesium stearate, poloxamer 188
1-855-288-4717
www.raphpharma.com
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.
Rapha Pharmaceuticals, Inc.
Orlando, Florida 32819 USA - PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1.5 MG (1 TABLET CARTON LABEL) - NDC 69953-628-60
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1.5 MG (1 TABLET CARTON LABEL) - NDC 69953-617-42
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1.5 MG (1 TABLET CARTON LABEL) - NDC 69953-618-43
-
INGREDIENTS AND APPEARANCE
POSTDAY ONE-STEP
levonorgestrel tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69953-617 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW) LEVONORGESTREL 1.5 mg in 1.5 mg Inactive Ingredients Ingredient Name Strength POLOXAMER 188 (UNII: LQA7B6G8JG) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) Product Characteristics Color white Score no score Shape ROUND Size 6mm Flavor Imprint Code C;1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69953-617-42 1 in 1 CARTON 01/16/2023 1 1 mg in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA205329 01/16/2023 POSTDAY ONE-STEP
levonorgestrel tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69953-628 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW) LEVONORGESTREL 1.5 mg in 1.5 mg Inactive Ingredients Ingredient Name Strength POLOXAMER 188 (UNII: LQA7B6G8JG) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) Product Characteristics Color white Score no score Shape ROUND Size 6mm Flavor Imprint Code C;1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69953-628-60 1 in 1 CARTON 01/16/2023 1 1 mg in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA205329 01/16/2023 POSTDAY ONE-STEP
levonorgestrel tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69953-618 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW) LEVONORGESTREL 1.5 mg in 1.5 mg Inactive Ingredients Ingredient Name Strength POLOXAMER 188 (UNII: LQA7B6G8JG) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) Product Characteristics Color white Score no score Shape ROUND Size 6mm Flavor Imprint Code C;1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69953-618-43 1 in 1 CARTON 11/21/2023 1 1 mg in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA205329 11/21/2023 Labeler - Rapha Pharmaceuticals, Inc. (079804155)