LEVONORGESTREL- levonorgestrel tablet 
Xiromed LLC

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Levonorgestrel Tablet 1.5 mg

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

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

Other information

Inactive ingredients

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

Questions?

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

Levonorgestrel Tablet 1.5 mg
Emergency Contraceptive
One Tablet. One Step.
What You Need to Know

What is levonorgestrel tablet 1.5 mg?

Levonorgestrel tablet 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 tablet 1.5 mg is not.

Levonorgestrel tablet 1.5 mg will not work if you are already pregnant and will not affect an existing pregnancy. Levonorgestrel tablet 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 tablet 1.5 mg?

The sooner you take emergency contraception, the better it works. You should use levonorgestrel tablet 1.5 mg within 72 hours (3 days) after you have had unprotected sex.

Levonorgestrel tablet 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 tablet 1.5 mg.

Levonorgestrel tablet 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 tablet 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 tablet 1.5 mg work?

Levonorgestrel tablet 1.5 mg works before release of an egg from the ovary. As a result, levonorgestrel tablet usually stops or delays the release of an egg from the ovary. Levonorgestrel tablet is one tablet that contains a higher dose of levonorgestrel than birth control pills and works in a similar way to prevent pregnancy.

How can I get the best results from levonorgestrel tablet 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 tablet 1.5 mg, the better it works.

How effective is levonorgestrel tablet 1.5 mg?

If levonorgestrel tablet 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 tablet 1.5 mg worked?

You will know levonorgestrel tablet 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 tablet 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 tablet 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.

Store at 20–25°C (68–77°F)

Active ingredient: levonorgestrel 1.5 mg

Inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, 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 tablet 1.5 mg

Manufactured by:
Laboratorios León Farma S.A.
C/La Vallina s/n
Poligono Industrial de
Navatejera
24008 Villaquilambre, León,
Spain


Manufactured for:
Xiromed, LLC.
Florham Park, NJ 07932





164-06-01 Rev. 09/2023



Priciple Display Panel - Blister

blister.jpg

Principle Display Panel - Carton

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

ctn.jpg


LEVONORGESTREL 
levonorgestrel tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70700-164
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Levonorgestrel (UNII: 5W7SIA7YZW) (Levonorgestrel - UNII:5W7SIA7YZW) Levonorgestrel1.5 mg
Inactive Ingredients
Ingredient NameStrength
Cellulose, Microcrystalline (UNII: OP1R32D61U)  
Lactose Monohydrate (UNII: EWQ57Q8I5X)  
Croscarmellose Sodium (UNII: M28OL1HH48)  
Poloxamer 188 (UNII: LQA7B6G8JG)  
Magnesium Stearate (UNII: 70097M6I30)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize6mm
FlavorImprint Code C;1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70700-164-061 in 1 CARTON03/13/2020
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20532903/13/2020
Labeler - Xiromed LLC (080228637)
Registrant - Xiromed Pharma España, S.L (468835741)
Establishment
NameAddressID/FEIBusiness Operations
Laboratorios León Farma S.A.467782459manufacture(70700-164) , analysis(70700-164) , pack(70700-164)

Revised: 9/2023
Document Id: 6ccbcf9e-fe8a-a97f-06f9-a4e4726d919c
Set id: 626a2333-ff56-ef28-a287-b33bacc0302a
Version: 6
Effective Time: 20230905
 
Xiromed LLC