Label: LEVONORGESTREL tablet
- NDC Code(s): 70700-164-06
- Packager: Xiromed LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated June 29, 2021
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- Drug Facts
- Active ingredient
Do not use
- if you are already pregnant (because it will not work)
- for regular birth control
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.
- When using this product you may have
- Keep out of reach of children.
- 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
- Levonorgestrel Tablets 1.5 mgEmergency ContraceptiveOne Tablet. One Step.What You Need to Know
- What is levonorgestrel tablets 1.5 mg?
- What levonorgestrel tablets 1.5 mg is not.
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.
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 tablet 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?
- How effective is levonorgestrel tablets 1.5 mg?
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, 1-844-947-6633, or visit our website at www.xiromed.com.
- Other Information
- Keep out of reach of children:
- Do not use if the blister seal is opened.
STORAGE AND HANDLING
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
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.
Levonorgestrel tablets 1.5 mg
Laboratorios León Farma S.A.
C/La Vallina s/n
Poligono Industrial de
24008 Villaquilambre, León,
Florham Park, NJ 07932
Revised: December 2019
- Priciple Display Panel - Blister
- Principle Display Panel - Carton
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70700-164 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Levonorgestrel (UNII: 5W7SIA7YZW) (Levonorgestrel - UNII:5W7SIA7YZW) Levonorgestrel 1.5 mg Inactive Ingredients Ingredient Name Strength Cellulose, Microcrystalline (UNII: OP1R32D61U) Lactose Monohydrate (UNII: EWQ57Q8I5X) Croscarmellose Sodium (UNII: M28OL1HH48) Poloxamer 188 (UNII: LQA7B6G8JG) Magnesium Stearate (UNII: 70097M6I30) 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:70700-164-06 1 in 1 CARTON 03/13/2020 1 1 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 03/13/2020 Labeler - Xiromed LLC (080228637) Registrant - Xiromed Pharma España, S.L (468835741) Establishment Name Address ID/FEI Business Operations Laboratorios León Farma S.A. 467782459 manufacture(70700-164) , analysis(70700-164) , pack(70700-164)