EContra One-Step ® (Levonorgestrel) Tablet 1.5 mg

Manufacturer
Rugby Laboratories, Inc.
Effective date
2023-06-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:27:49

Label at a glance#

ProductEmergency Contraceptive
Active ingredientLEVONORGESTREL
Label structure11 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 ( in each tablet)

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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking efavirenz (HIV medication) or rifampin (tuberculosis treatment) or medication for seizures (epilepsy). These medication may reduce the effectiveness of levonorgestrel.

When using the product you may have

OTC - WHEN USING SECTION

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

Keep out of reach children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

OTHER SAFETY 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 attachmentof a fertilized egg to the uterus (implantation).
  • do not use if package is open or blister seal is broken or missing
  • store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted to 15ºC to 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature].

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, poloxamer 188

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in Plan B One-Step**

Levonorgestrel Tablet 1.5 mg

Emergency Contraceptive

Reduces chances of pregnancy after unprotected sex

Not for regular birth control

One Tablet. One Step

  • The sooner you take it, the more effective it will be
  • Take as soon as possible within 72 hours (3 days) after unprotected sex
  • Will not harm an existing pregnancy

Tablet

*This product is not manufactured or distributed by Foundation Consumer Healthcare LLC, distributor of Plan B One Step®.

Distributed by:

RUGBY LABORATORIES

Indianapolis, IN 46268

Package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RUGBY Emergency Contraceptive
RUGBY Emergency Contraceptive

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1391-63EA - Each0536-1391c2abb088-9fb8-461a-80f0-aa5cc835fcc712023-12-05
70700-164-06EA - Each70700-1640f628079-3a28-4fb4-b812-eff2ba7eec6912020-04-20

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
0536-13910536-1391-63
70700-164

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 44.

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
A205329-001LEVONORGESTRELLEVONORGESTREL1.5MGTABLET / ORAL2018-09-18

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A205329-001LEVONORGESTREL1.5MGTABLET / ORAL2018-09-18c2088c7a36db…
2026-09-14 22:38:342026-08A205329-001LEVONORGESTREL1.5MGTABLET / ORAL2018-09-1884e616aacf4f…
2026-08-18 06:07:402026-07A205329-001LEVONORGESTREL1.5MGTABLET / ORAL2018-09-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205329-001LEVONORGESTREL1.5MGTABLET / ORAL2018-09-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205329-001LEVONORGESTREL1.5MGTABLET / ORAL2018-09-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A205329-001LEVONORGESTREL1.5MGTABLET / ORAL2018-09-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205329-001LEVONORGESTREL1.5MGTABLET / ORAL2018-09-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205329-001LEVONORGESTREL1.5MGTABLET / ORAL2018-09-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205329-001LEVONORGESTREL1.5MGTABLET / ORAL2018-09-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205329-001LEVONORGESTREL1.5MGTABLET / ORAL2018-09-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205329-001LEVONORGESTREL1.5MGTABLET / ORAL2018-09-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205329-001LEVONORGESTREL1.5MGTABLET / ORAL2018-09-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205329-001LEVONORGESTREL1.5MGTABLET / ORAL2018-09-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205329-001LEVONORGESTREL1.5MGTABLET / ORAL2018-09-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205329-001LEVONORGESTREL1.5MGTABLET / ORAL2018-09-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205329-001LEVONORGESTREL1.5MGTABLET / ORAL2018-09-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205329-001LEVONORGESTREL1.5MGTABLET / ORAL2018-09-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205329-001LEVONORGESTREL1.5MGTABLET / ORAL2018-09-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205329-001LEVONORGESTREL1.5MGTABLET / ORAL2018-09-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205329-001LEVONORGESTREL1.5MGTABLET / ORAL2018-09-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205329-001LEVONORGESTREL1.5MGTABLET / ORAL2018-09-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205329-001LEVONORGESTREL1.5MGTABLET / ORAL2018-09-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205329-001LEVONORGESTREL1.5MGTABLET / ORAL2018-09-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A205329-001LEVONORGESTREL1.5MGTABLET / ORAL2018-09-1887673890dc5c…
2021-03-12 10:30 UTC2021-03A205329-001LEVONORGESTREL1.5MGTABLET / ORAL2018-09-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A205329-001LEVONORGESTREL1.5MGTABLET / ORAL2018-09-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11A205329-001LEVONORGESTREL1.5MGTABLET / ORAL2018-09-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12A205329-001LEVONORGESTREL1.5MGTABLET / ORAL2018-09-183f01610625f2…
2019-09-15 20:21 UTC2019-09A205329-001LEVONORGESTREL1.5MGTABLET / ORAL2018-09-18b00525d2431f…
2019-07-19 19:46 UTC2019-07A205329-001LEVONORGESTREL1.5MGTABLET / ORAL2018-09-18ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A205329-001LEVONORGESTREL1.5MGTABLET / ORAL2018-09-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A205329-001LEVONORGESTREL1.5MGTABLET / ORAL2018-09-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12A205329-001LEVONORGESTREL1.5MGTABLET / ORAL2018-09-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A205329-001LEVONORGESTREL1.5MGTABLET / ORAL2018-09-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A205329-001LEVONORGESTREL1.5MGTABLET / ORAL2018-09-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A205329-001LEVONORGESTREL1.5MGTABLET / ORAL2018-09-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A205329-001LEVONORGESTREL1.5MGTABLET / ORAL2018-09-183f0d92c62455…
2023-05-13 08:27 UTC2023-05A205329-001LEVONORGESTREL1.5MGTABLET / ORAL2018-09-18053a50430f4f…
2023-01-26 05:58 UTC2023-01A205329-001LEVONORGESTREL1.5MGTABLET / ORAL2018-09-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A205329-001LEVONORGESTREL1.5MGTABLET / ORAL2018-09-183a93d1ddd44b…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
34df43e3-35bf-4d94-99cd-5ace15efa3574950fb25-042c-46d4-84ba-fe7f470118822024-02-08WarningsExact identifier
spl set id: 4950fb25-042c-46d4-84ba-fe7f47011882
LevonorgestrelLEVONORGESTRELXiromed LLC626a2333-ff56-ef28-a287-b33bacc0302a2023-09-05WarningsExact identifier
ndc (product): 70700-164

Reported adverse events (FAERS/openFDA)#

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