AfterPill® (levonorgestrel) Tablet, 1.5 mg

Manufacturer
Syzygy Healthcare Solutions, LLC PO Box 588, Westport, CT 06880 | LUPIN LIMITED
Effective date
2025-05-01
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:01:29

Label at a glance#

ProductAfterPill
Active ingredientLEVONORGESTREL
Label structure13 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Levonorgestrel USP 1.5 mg

Purpose

OTC - PURPOSE SECTION

Emergency contraceptive

Indications

INDICATIONS & USAGE SECTION

Use 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

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.

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

SPL UNCLASSIFIED SECTION

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).
  • tablet is enclosed in wallet seal. Do not use if the wallet seal is broken .
  • store at 25°C (77°C); excursions permitted to 15 to 30°C (59 to 86°C) [see USP Controlled Room temperature].

Inactive Ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, and povidone.

SPL UNCLASSIFIED SECTION

Questions or comments?

For more information, ask your healthcare professional or call 1-855-889-3012

M-F 8:00 am -4:00 pm (CST)

Visit our website at www.afterpill.com

SPL UNCLASSIFIED SECTION

AfterPill®

(levonorgestrel) Tablet, 1.5 mg

Emergency Contraceptive

One Tablet. One Dose.

What You Need to Know

SPL UNCLASSIFIED SECTION

What is AfterPill®?

AfterPill® 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 AfterPill Solo is not.

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

When should I use AfterPill?

DOSAGE & ADMINISTRATION SECTION

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

AfterPill 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

SPL UNCLASSIFIED SECTION

When not to use AfterPill?

AfterPill 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 AfterPill.

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 AfterPill 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 AfterPill work?

AfterPill works before release of an egg from the ovary. As a result, AfterPill usually stops or delays the release of an egg from the ovary. AfterPill 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 AfterPill?

You have 72 hours (3 days) to try to prevent pregnancy after birth control failure or unprotected sex. The sooner you take AfterPill, the better it works.

How effective is AfterPill?

If AfterPill 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 AfterPill worked?

You will know AfterPill 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, AfterPill 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 AfterPill?

If you have questions or need more information, call our toll-free number, 1-855-889-3012 or visit our website at www.afterpill.com.

Other Information

Keep this and all medication 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 wallet seal is opened.

Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].

Active Ingredient: levonorgestrel 1.5 mg

Inactive Ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, and povidone.

AfterPill® is a registered trademark of Syzygy Healthcare Solutions, LLC.

Manufactured in India for

Syzygy Healthcare Solutions, LLC

Syzygy Logo
Syzygy Logo

Revised: May 2023                                                                                                                 ID#: 273469

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AfterPill® (levonorgestrel) Tablet, 1.5 mg

NDC 64122-605-01

Wallet Label: 1 Tablet

AfterPill Wallet
AfterPill Wallet

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1545303AfterPill 1.5 MG Oral TabletPSN6
483325levonorgestrel 1.5 MG Oral TabletPSN6
1545303levonorgestrel 1.5 MG Oral Tablet [Afterpill]SBD6
483325levonorgestrel 1.5 MG Oral TabletSCD6
1545303Afterpill 1.5 MG Oral TabletSY6

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64122-605-012025-05-23C16284748780-12cef2736-b2d8-d83d-e063-dadaa90ab31fAfterPill® (levonorgestrel) Tablet, 1.5 mg
64122-605-012025-01-30C16284748780-12cef2736-b2d8-d83d-e063-dadaa90ab31fAfterPill® (levonorgestrel) Tablet, 1.5 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64122-605-01AfterPill1 in 1 BLISTER PACKTABLET16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64122-605AFTERPILL (LEVONORGESTREL) TABLET [SYZYGY HEALTHCARE SOLUTIONS, LLC PO BOX 588, WESTPORT, CT 06880]6Current NDC, Legacy NDC, 1 package rows20250524_4d284ba4-9cd7-48e4-95b9-cd6d0367bfd1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64122-605-01EA - Each64122-60587137f04-bf5a-4b49-8b83-23ee3e1336f212021-09-07

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
64122-60564122-605-01

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 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
A201446-001FALLBACK SOLOLEVONORGESTREL1.5MGTABLET / ORAL2014-06-19

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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2026-08-18 06:07:402026-07A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-19782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-1987673890dc5c…
2021-03-12 10:30 UTC2021-03A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-195aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-198869cabd3fbd…
2020-11-12 02:37 UTC2020-11A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-19c0c555d07b60…
2019-12-14 00:12 UTC2019-12A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-193f01610625f2…
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2024-02-18 07:12 UTC2024-02A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-191c564ffb4f44…
2023-12-20 04:57 UTC2023-12A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-19ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-19a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-199b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-19a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-193f0d92c62455…
2023-05-13 08:27 UTC2023-05A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-19053a50430f4f…
2023-01-26 05:58 UTC2023-01A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-193bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-193a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-19f41ea6bd6efb…

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
AfterPillLEVONORGESTRELSyzygy Healthcare Solutions, LLC PO Box 588, Westport, CT 068804d284ba4-9cd7-48e4-95b9-cd6d0367bfd12025-05-01WarningsExact identifier
ndc (package): 64122-605-01
ndc (product): 64122-605
ndc11 (package): 64122060501
spl id: 375a97f0-1569-4470-961d-93261430b139
spl set id: 4d284ba4-9cd7-48e4-95b9-cd6d0367bfd1

Reported adverse events (FAERS/openFDA)#

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