Restart - Winx Health Inc. | Naari Pharma Private Limited

Manufacturer
Winx Health Inc. | Naari Pharma Private Limited
Effective date
2026-02-24
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
weekly-update
Hydrated at
2026-07-17 21:43:23

Label at a glance#

ProductRestart
Active ingredientLEVONORGESTREL
Label structure2 sections

Label contents#

Full prescribing information#

Drug Facts

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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you aretaking 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 productyou may have

  • menstrual changes
  • nausea
  • lower stomach (abdominal) pain
  • tiredness
  • headaches
  • 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 at 1-800-222-1222

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 of taking the medication, call a healthcare professional to find out if you should repeat that dose.

Other information

STORAGE AND HANDLING SECTION

  • read the instructions, warnings, and enclosed product leaflet before use
  • do not use if the carton is open, if tear strip is removed or if blister seal is broken or missing
  • store at 20° to 25°C (68° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Lactose Monohydrate, Corn Starch, Potato Starch, Colloidal Silicon Dioxide, Talc and Magnesium Stearate.

Questions or comments?

OTC - QUESTIONS SECTION

The more information the better.

Drop us a note at hi@hellowinx.com
Tell us everything, nothing is TMI.

Toll Free Number
1-888-298-2620

Hours
Mon-Fri
9am-5pmEST

SPL UNCLASSIFIED SECTION

Distributed by Winx Health
9450 SW Gemini Dr PMB 53351,
Beaverton, OR, 97008


UK/Drugs/12/UA/SC/P-2009
Made in India

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 80584-103-01

Restart

Emergency contraceptive

Levonorgestrel 1.5 mg

Reduces chance of pregnancy after unprotected sex

Not for regular birth control

The sooner you take Restart, the more effective it is

Take within 3 days of unprotected sex

Will not harm an existing pregnancy

1 TABLET LEVONORGESTREL 1.5MG

winx-carton.jpgwinx-carton.jpg

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codeqrco.de/becAB6winx-carton.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8511fc19-172b-4e1f-90ec-2f09c85b16deProduct name220250116
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80584-10380584-103-01

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
62025-08-27full-release2026-06-01 01:11:57

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
A207660-001LEVONORGESTRELLEVONORGESTREL1.5MGTABLET / ORAL2019-05-02

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 06:07:402026-07A207660-001LEVONORGESTREL1.5MGTABLET / ORAL2019-05-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207660-001LEVONORGESTREL1.5MGTABLET / ORAL2019-05-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207660-001LEVONORGESTREL1.5MGTABLET / ORAL2019-05-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A207660-001LEVONORGESTREL1.5MGTABLET / ORAL2019-05-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207660-001LEVONORGESTREL1.5MGTABLET / ORAL2019-05-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207660-001LEVONORGESTREL1.5MGTABLET / ORAL2019-05-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207660-001LEVONORGESTREL1.5MGTABLET / ORAL2019-05-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207660-001LEVONORGESTREL1.5MGTABLET / ORAL2019-05-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207660-001LEVONORGESTREL1.5MGTABLET / ORAL2019-05-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207660-001LEVONORGESTREL1.5MGTABLET / ORAL2019-05-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207660-001LEVONORGESTREL1.5MGTABLET / ORAL2019-05-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207660-001LEVONORGESTREL1.5MGTABLET / ORAL2019-05-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207660-001LEVONORGESTREL1.5MGTABLET / ORAL2019-05-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207660-001LEVONORGESTREL1.5MGTABLET / ORAL2019-05-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207660-001LEVONORGESTREL1.5MGTABLET / ORAL2019-05-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207660-001LEVONORGESTREL1.5MGTABLET / ORAL2019-05-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207660-001LEVONORGESTREL1.5MGTABLET / ORAL2019-05-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207660-001LEVONORGESTREL1.5MGTABLET / ORAL2019-05-024b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207660-001LEVONORGESTREL1.5MGTABLET / ORAL2019-05-0274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207660-001LEVONORGESTREL1.5MGTABLET / ORAL2019-05-02bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207660-001LEVONORGESTREL1.5MGTABLET / ORAL2019-05-02782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207660-001LEVONORGESTREL1.5MGTABLET / ORAL2019-05-0287673890dc5c…
2021-03-12 10:30 UTC2021-03A207660-001LEVONORGESTREL1.5MGTABLET / ORAL2019-05-025aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207660-001LEVONORGESTREL1.5MGTABLET / ORAL2019-05-028869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207660-001LEVONORGESTREL1.5MGTABLET / ORAL2019-05-02c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207660-001LEVONORGESTREL1.5MGTABLET / ORAL2019-05-023f01610625f2…
2019-09-15 20:21 UTC2019-09A207660-001LEVONORGESTREL1.5MGTABLET / ORAL2019-05-02b00525d2431f…
2019-07-19 19:46 UTC2019-07A207660-001LEVONORGESTREL1.5MGTABLET / ORAL2019-05-02ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207660-001LEVONORGESTREL1.5MGTABLET / ORAL2019-05-026a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207660-001LEVONORGESTREL1.5MGTABLET / ORAL2019-05-021c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207660-001LEVONORGESTREL1.5MGTABLET / ORAL2019-05-02ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207660-001LEVONORGESTREL1.5MGTABLET / ORAL2019-05-02a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207660-001LEVONORGESTREL1.5MGTABLET / ORAL2019-05-029b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207660-001LEVONORGESTREL1.5MGTABLET / ORAL2019-05-02a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207660-001LEVONORGESTREL1.5MGTABLET / ORAL2019-05-023f0d92c62455…
2023-05-13 08:27 UTC2023-05A207660-001LEVONORGESTREL1.5MGTABLET / ORAL2019-05-02053a50430f4f…
2023-01-26 05:58 UTC2023-01A207660-001LEVONORGESTREL1.5MGTABLET / ORAL2019-05-023bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207660-001LEVONORGESTREL1.5MGTABLET / ORAL2019-05-023a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207660-001LEVONORGESTREL1.5MGTABLET / ORAL2019-05-02f41ea6bd6efb…

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
RestartLEVONORGESTRELWinx Health Inc.0cdf198e-c114-b9fa-e063-6294a90a566a2026-02-24WarningsExact identifier
ndc (package): 80584-103-01
ndc (product): 80584-103
ndc11 (package): 80584010301
spl id: 4b9d2263-945a-ebca-e063-6394a90a1beb
spl set id: 0cdf198e-c114-b9fa-e063-6294a90a566a

Reported adverse events (FAERS/openFDA)#

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