Levonorgestrel by Xiromed LLC / Xiromed Pharma España, S.L / Laboratorios León Farma S.A. LEVONORGESTREL tablet

Levonorgestrel by

Drug Labeling and Warnings

Levonorgestrel by is a Otc medication manufactured, distributed, or labeled by Xiromed LLC, Xiromed Pharma España, S.L, Laboratorios León Farma S.A.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Levonorgestrel 1.5 mg

Purpose

Emergency contraceptive

Use

for women to reduce chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use birth control)

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

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

menstrual changes	tiredness	breast pain
nausea	headache	vomiting
lower stomach (abdominal) pain	dizziness

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control center right away.

Directions

• take 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

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

cellulose microcrystalline, croscarmellose sodium, lactose monohydrate, magnesium stearate, poloxamer 188

Questions?

Call 1-844-947-6633  Monday-Friday 9AM-5PM EST

Levonorgestrel Tablets 1.5 mgEmergency ContraceptiveOne 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 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?

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, 1-844-947-6633, or visit our website at www.xiromed.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 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

1-844-947-6633

www.xiromed.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.

XIROMED, LLC.
Levonorgestrel tablets 1.5 mg

Revised: December 2019

Priciple Display Panel - Blister

Principle Display Panel - Carton

Levonorgestrel Tablets
(levonorgestrel) tablets 1.5 mg
Emergency contraceptive
Reduces chance of pregnancy after unprotected sex.
Not for regular birth control.
Xiromed LLC.

INGREDIENTS AND APPEARANCE

LEVONORGESTREL 
levonorgestrel tablet

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	02/20/2020
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	02/20/2020

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)