Levonorgestrel Tablet

Manufacturer
GLENMARK THERAPEUTICS INC., USA | Glenmark Pharmaceuticals Limited
Effective date
2026-07-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-07-18 05:11:09

Label at a glance#

ProductLevonorgestrel
Active ingredientLEVONORGESTREL
Label structure26 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

Active ingredient: levonorgestrel, USP 1.5 mg Inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, potato starch, talc. 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 birt...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Levonorgestrel, USP 1.5mg

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 disease (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

OTC - ASK DOCTOR/PHARMACIST 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.

When using this product you may have

OTC - WHEN USING SECTION

  • menstrual changes
  • nausea
  • lower stomach (abdominal) pain
  • tiredness
  • headache
  • breast pain
  • vomiting
  • 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 tear strip is removed or blister seal is broken or missing
  • Store at room temperature, 20°C to 25°C (68°F to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, potato starch, talc

What is Levonorgestrel Tablet?

SPL UNCLASSIFIED SECTION

Levonorgestrel Tablet 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 is not.

SPL UNCLASSIFIED SECTION

Levonorgestrel Tablet will not work if you are already pregnant and will not affect an existing pregnancy. Levonorgestrel Tablet will not protect you from HIV infection (the virus that causes AIDS) and other sexually transmitted diseases (STDs).

When should I use Levonorgestrel Tablet?

DOSAGE & ADMINISTRATION SECTION

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

Levonorgestrel Tablet 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.

SPL UNCLASSIFIED SECTION

Levonorgestrel Tablet 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.

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 work?

SPL UNCLASSIFIED SECTION

Levonorgestrel Tablet 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 the birth control pills and works in a similar way to prevent pregnancy.

How can I get the best results from Levonorgestrel Tablet?

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, the better it works.

How effective is Levonorgestrel Tablet?

SPL UNCLASSIFIED SECTION

If Levonorgestrel Tablet 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 worked?

SPL UNCLASSIFIED SECTION

You will know Levonorgestrel Tablet 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

  • 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 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?

SPL UNCLASSIFIED SECTION

If you have questions or need more information, call our toll-free number 1 (888) 721-7115 or visit our website at www.glenmarkpharma-us.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.

Store at room temperature, 20°C to 25°C (68°F to 77°F).

STORAGE AND HANDLING SECTION

Active ingredient: levonorgestrel, USP 1.5 mg

Inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, potato starch, talc.

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.

Manufactured by:

Glenmark Pharmaceuticals Limited

Colvale-Bardez, Goa 403513, India

Questions? 1 (888) 721-711

www.glenmarkpharma-us.com

September 2025

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

carton
carton

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130372657123112GTIN-13: 0372657123112
EAN-13: 0372657123112
GTIN-12: 372657123112
UPC-A: 372657123112
GTIN storage (14 digits): 00372657123112
carton.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
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DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72657-123-11EA - Each72657-123f54680e0-3b81-4eb5-831f-d951251b3ad812025-12-16

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72657-12372657-123-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12023-02-09full-release2026-05-31 23:54:06

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 43.

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
A207044-001LEVONORGESTRELLEVONORGESTREL1.5MGTABLET / ORAL2016-03-25

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 · 43 observed states.

Captured, Edition, Application-product table
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2026-02-19 14:30 UTC2026-02A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-25011fe1cb6892…
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2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-255d02ea3f76ae…
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2021-12-28 21:50 UTC2021-12A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-25782e0a99824c…
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2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-253f0d92c62455…
2023-05-13 08:27 UTC2023-05A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-25053a50430f4f…
2023-01-26 05:58 UTC2023-01A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-253bdfa0b2c4d7…
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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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LevonorgestrelLEVONORGESTRELGLENMARK THERAPEUTICS INC., USA07567b80-d8a1-41c0-95e4-33afa584bbc42026-07-15WarningsExact identifier
ndc (package): 72657-123-11
ndc (product): 72657-123
ndc11 (package): 72657012311
spl id: dc52c295-f2ff-46a9-8a66-e3b786480ee1
spl set id: 07567b80-d8a1-41c0-95e4-33afa584bbc4

Reported adverse events (FAERS/openFDA)#

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