My Way

Manufacturer
Lupin Pharmaceuticals,Inc. | GAVIS Pharmaceuticals, LLC | Novel Laboratories, Inc.
Effective date
2016-06-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:46:25

Label at a glance#

ProductMy Way
Active ingredientLEVONORGESTREL
Label structure12 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#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Levonorgestrel 1.5mg

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

OTC - DO NOT USE SECTION

  • if you are already pregnant (because it will not work)
  • for regular birth control

When using this product you may have

OTC - WHEN USING SECTION

  • 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 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, pregelatinized starch, lactose monohydrate, magnesium stearate and talc

Questions?

OTC - QUESTIONS SECTION

For more information or to speak to a healthcare professional, call 1-800-422-8689 or visit our website at www.mywaypill.com

My Way 

Emergency Contraceptive

What You Need to Know

What is My Way?

My Way 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 My Way is not.

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

When should I use My Way?

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

My Way 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 My Way.

My Way 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 My Way .

How does My Way work?

My Way is one tablet with levonorgestrel, a hormone that has been used in many birth control pills for several decades. My Way 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 My Way 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 My Way?

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

How effective is My Way?

If My Way 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 My Way worked?

You will know My Way 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, My Way  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 My Way?

If you have questions or need more information, call 1-800-422-8689, or visit our website at www.mywaypill.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 room temperature 20–25°C (68–77°F).

Active ingredient: levonorgestrel 1.5 mg

Inactive ingredients: colloidal silicon dioxide, pregelatinized starch, lactose monohydrate, magnesium stearate, and 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:

Novel Laboratories, Inc.

Somerset, NJ 08873

PI6223000201

Rev. 02/2014

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

My Way (levonorgestrel) Tablet , 1.5 mg

NDC 43386-622-30

emergency contraceptive

Reduces chance of pregnancy after unprotected sex.

Not for regular birth control.

Contains 1 Tablet 1.5mg

Front Panel

C:\Users\kvyas\Desktop\spl\front panel.jpg
C:\Users\kvyas\Desktop\spl\front panel.jpg

Back Panel

C:\Users\kvyas\Desktop\spl\drug facts.jpg
C:\Users\kvyas\Desktop\spl\drug facts.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
483325levonorgestrel 1.5 MG Oral TabletPSN3
1426881My Way Emergency Contraceptive 1.5 MG Oral TabletPSN3
1426881levonorgestrel 1.5 MG Oral Tablet [My Way]SBD3
483325levonorgestrel 1.5 MG Oral TabletSCD3
1426881My Way 1.5 MG Oral TabletSY3

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
43386-622-30My Way1 in 1 CARTONTABLET13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43386-622MY WAY (LEVONORGESTREL) TABLET [LUPIN PHARMACEUTICALS,INC.]3Current NDC, Legacy NDC, 1 package rows20160629_ec01077e-ac3c-424a-9edc-0854fe0a2e0d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43386-622-30EA - Each43386-62284c2c455-5cc0-4e64-a10a-b3174897d1e412014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
LEVONORGESTRELACTIVE INGREDIENT5W7SIA7YZW2
LEVONORGESTRELACTIVE MOIETY5W7SIA7YZW2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5X2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I302
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU42
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ2
TALCINACTIVE INGREDIENT7SEV7J4R1U2

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
43386-62243386-622-30

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

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 10 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET / ORAL1000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET / ORAL1000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XTABLET / ORAL4384 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XTABLET / ORAL4384 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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
A202508-001LEVONORGESTRELLEVONORGESTREL1.5MGTABLET / ORAL2013-02-22

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
2026-09-14 22:38:342026-08A202508-001LEVONORGESTREL1.5MGTABLET / ORAL2013-02-2284e616aacf4f…
2026-08-18 06:07:402026-07A202508-001LEVONORGESTREL1.5MGTABLET / ORAL2013-02-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202508-001LEVONORGESTREL1.5MGTABLET / ORAL2013-02-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202508-001LEVONORGESTREL1.5MGTABLET / ORAL2013-02-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A202508-001LEVONORGESTREL1.5MGTABLET / ORAL2013-02-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202508-001LEVONORGESTREL1.5MGTABLET / ORAL2013-02-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202508-001LEVONORGESTREL1.5MGTABLET / ORAL2013-02-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202508-001LEVONORGESTREL1.5MGTABLET / ORAL2013-02-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202508-001LEVONORGESTREL1.5MGTABLET / ORAL2013-02-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202508-001LEVONORGESTREL1.5MGTABLET / ORAL2013-02-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202508-001LEVONORGESTREL1.5MGTABLET / ORAL2013-02-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202508-001LEVONORGESTREL1.5MGTABLET / ORAL2013-02-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202508-001LEVONORGESTREL1.5MGTABLET / ORAL2013-02-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202508-001LEVONORGESTREL1.5MGTABLET / ORAL2013-02-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202508-001LEVONORGESTREL1.5MGTABLET / ORAL2013-02-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202508-001LEVONORGESTREL1.5MGTABLET / ORAL2013-02-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202508-001LEVONORGESTREL1.5MGTABLET / ORAL2013-02-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202508-001LEVONORGESTREL1.5MGTABLET / ORAL2013-02-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202508-001LEVONORGESTREL1.5MGTABLET / ORAL2013-02-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202508-001LEVONORGESTREL1.5MGTABLET / ORAL2013-02-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202508-001LEVONORGESTREL1.5MGTABLET / ORAL2013-02-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202508-001LEVONORGESTREL1.5MGTABLET / ORAL2013-02-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202508-001LEVONORGESTREL1.5MGTABLET / ORAL2013-02-2287673890dc5c…
2021-03-12 10:30 UTC2021-03A202508-001LEVONORGESTREL1.5MGTABLET / ORAL2013-02-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202508-001LEVONORGESTREL1.5MGTABLET / ORAL2013-02-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202508-001LEVONORGESTREL1.5MGTABLET / ORAL2013-02-22c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202508-001LEVONORGESTREL1.5MGTABLET / ORAL2013-02-223f01610625f2…
2019-09-15 20:21 UTC2019-09A202508-001LEVONORGESTREL1.5MGTABLET / ORAL2013-02-22b00525d2431f…
2019-07-19 19:46 UTC2019-07A202508-001LEVONORGESTREL1.5MGTABLET / ORAL2013-02-22ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202508-001LEVONORGESTREL1.5MGTABLET / ORAL2013-02-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202508-001LEVONORGESTREL1.5MGTABLET / ORAL2013-02-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202508-001LEVONORGESTREL1.5MGTABLET / ORAL2013-02-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202508-001LEVONORGESTREL1.5MGTABLET / ORAL2013-02-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202508-001LEVONORGESTREL1.5MGTABLET / ORAL2013-02-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202508-001LEVONORGESTREL1.5MGTABLET / ORAL2013-02-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202508-001LEVONORGESTREL1.5MGTABLET / ORAL2013-02-223f0d92c62455…
2023-05-13 08:27 UTC2023-05A202508-001LEVONORGESTREL1.5MGTABLET / ORAL2013-02-22053a50430f4f…
2023-01-26 05:58 UTC2023-01A202508-001LEVONORGESTREL1.5MGTABLET / ORAL2013-02-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202508-001LEVONORGESTREL1.5MGTABLET / ORAL2013-02-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202508-001LEVONORGESTREL1.5MGTABLET / ORAL2013-02-22f41ea6bd6efb…

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
My WayLEVONORGESTRELLupin Pharmaceuticals,Inc.ec01077e-ac3c-424a-9edc-0854fe0a2e0d2016-06-17WarningsExact identifier
ndc (package): 43386-622-30
ndc (product): 43386-622
ndc11 (package): 43386062230
spl id: 6dce7821-019c-4344-9634-5a51060920d5
spl set id: ec01077e-ac3c-424a-9edc-0854fe0a2e0d

Reported adverse events (FAERS/openFDA)#

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