Levonorgestrel Tablet 1.5 mg

Manufacturer
Xiromed LLC | Xiromed Pharma España, S.L | Laboratorios León Farma S.A.
Effective date
2023-09-05
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 23:56:05

Label at a glance#

ProductLevonorgestrel
Active ingredientLevonorgestrel
Label structure27 sections

Dosage and administration

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

Storage and handling

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 di...

Label contents#

Full prescribing information#

SPL PRODUCT DATA ELEMENTS SECTION

SPL UNCLASSIFIED SECTION

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Levonorgestrel 1.5 mg

Purpose

OTC - PURPOSE SECTION

Emergency contraceptive

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

  • 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

OTC - WHEN USING SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

INSTRUCTIONS FOR USE SECTION

  • 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

SPL UNCLASSIFIED SECTION

  • read the instructions, warnings and enclosed product leaflet before use

  • do not use if carton is open or blister seal is broken or missing

  • store at 20–25°C (68–77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

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

What is levonorgestrel tablet 1.5 mg?

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

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?

DOSAGE & ADMINISTRATION SECTION

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:

  1. your regular birth control was used incorrectly or failed
  2. you did not use any birth control method

When not to use levonorgestrel tablet 1.5 mg.

SPL UNCLASSIFIED SECTION

Levonorgestrel tablet 1.5 mg should not be used:

  1. as a regular birth control method, because it’s not as effective as regular birth control.
  2. if you are already pregnant, because it will not work.
  3. 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?

SPL UNCLASSIFIED SECTION

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?

SPL UNCLASSIFIED SECTION

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?

SPL UNCLASSIFIED SECTION

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?

SPL UNCLASSIFIED SECTION

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?

SPL UNCLASSIFIED SECTION

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?

SPL UNCLASSIFIED SECTION

  1. 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.
  2. if you have severe abdominal pain, you may have an ectopic pregnancy, and should get immediate medical attention.
  3. 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.
  4. 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?

SPL UNCLASSIFIED SECTION

If you have questions or need more information, call our toll-free number, 1-844-947-6633, or visit our website at www.PlanBOneStep.com.

Keep out of reach of children:

SPL UNCLASSIFIED SECTION

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

STORAGE AND HANDLING SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

blister.jpgblister.jpg

Principle Display Panel - Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

ctn.jpgctn.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
483325levonorgestrel 1.5 MG Oral TabletPSN6
483325levonorgestrel 1.5 MG Oral TabletSCD6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LEVONORGESTREL Pharmacologic Class Indexing3Indexing - Pharmacologic Class20230718

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8511fc19-172b-4e1f-90ec-2f09c85b16deProduct name220250116
a0f93f28-4e91-4bb1-8dcb-5456fd4bfc50Product name320230718
fa479cfe-0bd0-7366-d57a-92f3682e87c5Product name320210518
20e1a411-dba8-4afa-b9f9-1205d5b0bde9Product name320210513
5956a0e2-c373-452c-bdcf-c93d354432efProduct name120200714
ca306105-d51c-4821-9ec1-8eec753d073dProduct name120200619
d2c4820a-bb24-f61d-8cd0-dd0290a6bd4dProduct name720190612
f92411e4-13dd-7baf-106e-9b3fcf758c39Product name420190502
f713a022-3e1c-4035-bc91-62131bc80b42Product name220190125
79d5025d-8129-440a-b861-6df2d2661609Product name320180607
d871c48c-6b0b-4203-b55d-72ead21ea7adProduct name520180419
12434b90-2738-45d5-9e1b-55001e853273Product name220171122
741e98f2-ac6c-4d80-9ca8-c663c171ba1dProduct name120161121
cc765024-f257-4c67-b780-c356aadd6980Product name320150902
5a9b579b-8431-5b3a-2ba4-86556704f873Product name120140508
5f44c957-835a-ada0-662f-5b1071b7a68bProduct name120140508
d03a75af-b11b-673b-268b-318050d0b3bdProduct name120140508
d0cc7d42-77a7-b452-c6c3-a162fa11225fProduct name120140508
e5ccd419-1745-560a-1e25-c6e3941c710aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70700-164-06Levonorgestrel1 in 1 BLISTER PACKTABLET16
70700-164-06Levonorgestrel1 in 1 CARTONTABLET16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70700-164LEVONORGESTREL TABLET [XIROMED LLC]6Current NDC, Legacy NDC, 2 package rows20230906_626a2333-ff56-ef28-a287-b33bacc0302a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70700-164-06EA - Each70700-1640f628079-3a28-4fb4-b812-eff2ba7eec6912020-04-20

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70700-16470700-164-06

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A205329-001LEVONORGESTRELLEVONORGESTREL1.5MGTABLET / ORAL2018-09-18

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 44 observed states.

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2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205329-001LEVONORGESTREL1.5MGTABLET / ORAL2018-09-181e350fbaab3a…
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2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A205329-001LEVONORGESTREL1.5MGTABLET / ORAL2018-09-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A205329-001LEVONORGESTREL1.5MGTABLET / ORAL2018-09-183f0d92c62455…
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openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LevonorgestrelLEVONORGESTRELXiromed LLC626a2333-ff56-ef28-a287-b33bacc0302a2023-09-05WarningsExact identifier
ndc (package): 70700-164-06
ndc (product): 70700-164
ndc11 (package): 70700016406
spl id: 6ccbcf9e-fe8a-a97f-06f9-a4e4726d919c
spl set id: 626a2333-ff56-ef28-a287-b33bacc0302a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.