OTC - ACTIVE INGREDIENT SECTION
Levonorgestrel USP 1.5 mg
Levonorgestrel USP 1.5 mg
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).
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
Keep out of the reach of children.
In case of overdose, get medical help or contact a Poison Control center right away.
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).
Do not use if carton is open or blister seal is broken or missing .
store at 25°C (77°C); excursions permitted to 15 to 30°C (59 to 86°C) [see USP Controlled Room temperature].
colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, and povidone.
| Class | Version | Type | Effective |
|---|---|---|---|
| LEVONORGESTREL Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20230718 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 76519-1164-0 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-84fb-a426-e053-dadaa90af4c2 | 1164 LEVONORGESTREL |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76519-1164-0 | LEVONORGESTREL | 1 in 1 BOX | TABLET | 1 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 76519-1164 | LEVONORGESTREL TABLET [H.J. HARKINS COMPANY, INC.] | 1 | Legacy NDC, 1 package rows | 20190926_92dcd064-5d9f-29b6-e053-2a95a90a1bf1.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 76519-1164 | 76519-1164-0 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| LACTOSE MONOHYDRATE | EWQ57Q8I5X | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| LEVONORGESTREL | 5W7SIA7YZW | ACTIB |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A201446-001 | FALLBACK SOLO | LEVONORGESTREL | 1.5MG | TABLET / ORAL | 2014-06-19 |
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 | A201446-001 | FALLBACK SOLO | 1.5MG | TABLET / ORAL | 2014-06-19 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A201446-001 | FALLBACK SOLO | 1.5MG | TABLET / ORAL | 2014-06-19 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A201446-001 | FALLBACK SOLO | 1.5MG | TABLET / ORAL | 2014-06-19 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201446-001 | FALLBACK SOLO | 1.5MG | TABLET / ORAL | 2014-06-19 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A201446-001 | FALLBACK SOLO | 1.5MG | TABLET / ORAL | 2014-06-19 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201446-001 | FALLBACK SOLO | 1.5MG | TABLET / ORAL | 2014-06-19 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201446-001 | FALLBACK SOLO | 1.5MG | TABLET / ORAL | 2014-06-19 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201446-001 | FALLBACK SOLO | 1.5MG | TABLET / ORAL | 2014-06-19 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201446-001 | FALLBACK SOLO | 1.5MG | TABLET / ORAL | 2014-06-19 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201446-001 | FALLBACK SOLO | 1.5MG | TABLET / ORAL | 2014-06-19 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A201446-001 | FALLBACK SOLO | 1.5MG | TABLET / ORAL | 2014-06-19 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A201446-001 | FALLBACK SOLO | 1.5MG | TABLET / ORAL | 2014-06-19 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A201446-001 | FALLBACK SOLO | 1.5MG | TABLET / ORAL | 2014-06-19 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A201446-001 | FALLBACK SOLO | 1.5MG | TABLET / ORAL | 2014-06-19 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A201446-001 | FALLBACK SOLO | 1.5MG | TABLET / ORAL | 2014-06-19 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A201446-001 | FALLBACK SOLO | 1.5MG | TABLET / ORAL | 2014-06-19 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A201446-001 | FALLBACK SOLO | 1.5MG | TABLET / ORAL | 2014-06-19 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A201446-001 | FALLBACK SOLO | 1.5MG | TABLET / ORAL | 2014-06-19 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A201446-001 | FALLBACK SOLO | 1.5MG | TABLET / ORAL | 2014-06-19 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A201446-001 | FALLBACK SOLO | 1.5MG | TABLET / ORAL | 2014-06-19 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A201446-001 | FALLBACK SOLO | 1.5MG | TABLET / ORAL | 2014-06-19 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A201446-001 | FALLBACK SOLO | 1.5MG | TABLET / ORAL | 2014-06-19 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A201446-001 | FALLBACK SOLO | 1.5MG | TABLET / ORAL | 2014-06-19 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A201446-001 | FALLBACK SOLO | 1.5MG | TABLET / ORAL | 2014-06-19 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A201446-001 | FALLBACK SOLO | 1.5MG | TABLET / ORAL | 2014-06-19 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A201446-001 | FALLBACK SOLO | 1.5MG | TABLET / ORAL | 2014-06-19 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A201446-001 | FALLBACK SOLO | 1.5MG | TABLET / ORAL | 2014-06-19 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A201446-001 | FALLBACK SOLO | 1.5MG | TABLET / ORAL | 2014-06-19 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A201446-001 | FALLBACK SOLO | 1.5MG | TABLET / ORAL | 2014-06-19 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A201446-001 | FALLBACK SOLO | 1.5MG | TABLET / ORAL | 2014-06-19 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A201446-001 | FALLBACK SOLO | 1.5MG | TABLET / ORAL | 2014-06-19 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A201446-001 | FALLBACK SOLO | 1.5MG | TABLET / ORAL | 2014-06-19 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A201446-001 | FALLBACK SOLO | 1.5MG | TABLET / ORAL | 2014-06-19 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A201446-001 | FALLBACK SOLO | 1.5MG | TABLET / ORAL | 2014-06-19 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A201446-001 | FALLBACK SOLO | 1.5MG | TABLET / ORAL | 2014-06-19 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A201446-001 | FALLBACK SOLO | 1.5MG | TABLET / ORAL | 2014-06-19 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A201446-001 | FALLBACK SOLO | 1.5MG | TABLET / ORAL | 2014-06-19 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A201446-001 | FALLBACK SOLO | 1.5MG | TABLET / ORAL | 2014-06-19 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A201446-001 | FALLBACK SOLO | 1.5MG | TABLET / ORAL | 2014-06-19 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A201446-001 | FALLBACK SOLO | 1.5MG | TABLET / ORAL | 2014-06-19 | f41ea6bd6efb… |
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 |
|---|---|---|---|---|---|---|
| 92dcd064-5da0-29b6-e053-2a95a90a1bf1 | 92dcd064-5d9f-29b6-e053-2a95a90a1bf1 | 2019-09-18 | Warnings | 92dcd064-5da0-29b6-e053-2a95a90a1bf1 92dcd064-5d9f-29b6-e053-2a95a90a1bf1 |
Adverse event summaries are temporarily unavailable. Other product information remains available.