Levonorgestrel Tablet, 1.5 mg

Manufacturer
Strides Pharma Inc | Naari Pte. Limited | Haupt Pharma Muenster GmbH
Effective date
2022-09-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:50:40

Label at a glance#

ProductLevonorgestrel Tablet, 1.5 mg
Active ingredientLEVONORGESTREL
Label structure14 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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

 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

OTC - ASK DOCTOR/PHARMACIST SECTION

taking efavirenz (HIV medication) or rifampin (tuberculosis treatment) or medication for seizures (epilepsy). These medications may reduce the effectiveness of levonorgestrel.

OTC - WHEN USING SECTION

When using this product you may have

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

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

DOSAGE & ADMINISTRATION 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
  • 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 carton is open or blister seal is broken or missing
  • store at 20° to 25°C (68° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Colloidal silicon dioxide, FD&C Yellow No. 6 aluminum lake, lactose monohydrate, magnesium stearate, and pregelatinized starch

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-244-9825.

Manufactured for:

Strides Pharma Inc.

East Brunswick, NJ 08816

Product made in Germany

INFORMATION FOR PATIENTS

INFORMATION FOR PATIENTS SECTION

Levonorgestrel Tablet 1.5 mg

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. The 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 the 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 1.5 mg 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 the Levonorgestrel Tablet 1.5 mg work?

Levonorgestrel Tablet 1.5 mg is one tablet with levonorgestrel, a hormone that has been used in many birth control pills for several decades. Levonorgestrel Tablet 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 Tablet 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 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, 1-877-244-9825.

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

Active ingredient: levonorgestrel 1.5 mg

Inactive ingredients: colloidal silicon dioxide, FD&C Yellow No. 6 aluminum lake, lactose monohydrate, magnesium stearate, and pregelatinized starch

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 for:

Strides Pharma Inc.

East Brunswick, NJ 08816

Product made in Germany.

 Issued: 09/2022

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

carton label
carton label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
483325levonorgestrel 1.5 MG Oral TabletPSN1
483325levonorgestrel 1.5 MG Oral TabletSCD1

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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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
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d871c48c-6b0b-4203-b55d-72ead21ea7adProduct name520180419
12434b90-2738-45d5-9e1b-55001e853273Product name220171122
741e98f2-ac6c-4d80-9ca8-c663c171ba1dProduct name120161121
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5a9b579b-8431-5b3a-2ba4-86556704f873Product name120140508
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d03a75af-b11b-673b-268b-318050d0b3bdProduct name120140508
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e5ccd419-1745-560a-1e25-c6e3941c710aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59556-282-01Levonorgestrel Tablet, 1.5 mg1 in 1 BLISTER PACKTABLET11
59556-282-01Levonorgestrel Tablet, 1.5 mg1 in 1 CARTONTABLET11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59556-282LEVONORGESTREL TABLET, 1.5 MG TABLET [STRIDES PHARMA INC]1Current NDC, Legacy NDC, 2 package rows20220916_98f6367e-14d2-4c7a-9418-d996f0040d22.zip

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
59556-28259556-282-01

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
A202380-001LEVONORGESTRELLEVONORGESTREL1.5MGTABLET / ORAL2015-05-29

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.

Captured, Edition, Application-product table
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2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-295bbf6a4d5a75…
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2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-291e350fbaab3a…
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2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-293f0d92c62455…
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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
Levonorgestrel Tablet, 1.5 mgLEVONORGESTREL TABLET, 1.5 MGStrides Pharma Inc98f6367e-14d2-4c7a-9418-d996f0040d222022-09-13WarningsExact identifier
ndc (package): 59556-282-01
ndc (product): 59556-282
ndc11 (package): 59556028201
spl id: 7a2ca863-fe8b-4ee6-9a63-40276db84b77
spl set id: 98f6367e-14d2-4c7a-9418-d996f0040d22

Reported adverse events (FAERS/openFDA)#

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