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#
Contacts and useful links#
Label contents#
Full prescribing information#
Drug Facts
Active ingredient
Levonorgestrel 1.5 mg
Purpose
Emergency contraceptive
Use
for women to reduce chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use birth control)
Warnings
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
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.
In case of overdose, get medical help or contact a Poison Control center right away at 1-800-222-1222
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 of taking the medication, call a healthcare professional to find out if you should repeat that dose.
Other information
- 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
Lactose Monohydrate, Corn Starch, Potato Starch, Colloidal Silicon Dioxide, Talc and Magnesium Stearate.
Questions or comments?
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
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| QR code link | QR Code | winx-carton.jpg |
DailyMed Product Concepts#
Products#
Every source-derived product name is available through these pages.
- Restart
- Levonorgestrel
- MAGNESIUM STEARATE
- STARCH, CORN
- TALC
- LACTOSE MONOHYDRATE
- SILICON DIOXIDE
- STARCH, POTATO
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 80584-103 | 80584-103-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| TALC | 7SEV7J4R1U | IACT |
| LACTOSE MONOHYDRATE | EWQ57Q8I5X | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| STARCH, POTATO | 8I089SAH3T | IACT |
| LEVONORGESTREL | 5W7SIA7YZW | ACTIB |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 6 | 2025-08-27 | full-release | 2026-06-01 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 products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A207660-001 | LEVONORGESTREL | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2019-05-02 |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A207660-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2019-05-02 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A207660-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2019-05-02 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A207660-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2019-05-02 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207660-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2019-05-02 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A207660-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2019-05-02 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207660-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2019-05-02 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207660-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2019-05-02 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207660-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2019-05-02 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207660-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2019-05-02 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207660-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2019-05-02 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207660-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2019-05-02 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A207660-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2019-05-02 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207660-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2019-05-02 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207660-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2019-05-02 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207660-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2019-05-02 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A207660-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2019-05-02 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207660-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2019-05-02 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A207660-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2019-05-02 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A207660-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2019-05-02 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A207660-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2019-05-02 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A207660-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2019-05-02 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A207660-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2019-05-02 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A207660-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2019-05-02 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A207660-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2019-05-02 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A207660-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2019-05-02 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A207660-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2019-05-02 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A207660-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2019-05-02 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A207660-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2019-05-02 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A207660-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2019-05-02 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A207660-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2019-05-02 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A207660-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2019-05-02 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A207660-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2019-05-02 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A207660-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2019-05-02 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A207660-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2019-05-02 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A207660-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2019-05-02 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A207660-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2019-05-02 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A207660-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2019-05-02 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A207660-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2019-05-02 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A207660-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2019-05-02 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A207660-001 | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2019-05-02 | f41ea6bd6efb… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Restart | LEVONORGESTREL | Winx Health Inc. | 0cdf198e-c114-b9fa-e063-6294a90a566a | 2026-02-24 | Warnings | 80584-103-01 80584-103 80584010301 4b9d2263-945a-ebca-e063-6394a90a1beb 0cdf198e-c114-b9fa-e063-6294a90a566a |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
