BionaFem

Manufacturer
Bionpharma Inc. | Glenmark Pharmaceuticals Limited
Effective date
2019-04-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:25:57

Label at a glance#

ProductBionaFem
Active ingredientLEVONORGESTREL
Label structure14 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

Storage and handling

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 tear strip is removed or blister seal is broken or missing store at 20° to 25°C (68° to 77°F)

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Levonorgestrel, USP 1.5mg

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 medications may reduce the effectiveness of levonorgestrel.

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 (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 after taking the medication, call a healthcare professional to find out if you should repeat the dose

Other information

STORAGE AND HANDLING 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 tear strip is removed or blister seal is broken or missing
  • store at 20° to 25°C (68° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, corn starch, hypromellose, lactose monohydrate, magnesium stearate, potato starch, talc

Questions or comments?

OTC - QUESTIONS SECTION

For more information, call toll free 1-888-235-2466 weekdays

SPL UNCLASSIFIED SECTION

†Plan B One-Step® is a registered trademark of Women's Capital Corporation

Distributed by:

BIONPHARMA

600 Alexander Road,

Princeton, NJ 08540

Manufactured by:

Glenmark Pharmaceuticals Ltd.

Colvale-Bardez, Goa 403513, India

MADE IN INDIA

GO/DRUGS/785

01/19

Package Label.Principal Display Panel

NDC 69452-243-60

†Compare to the active ingredient of Plan B One-Step®

BionaFemTM

Levonorgestrel Tablet 1.5 mg

Emergency Contraceptive

One Tablet. One Step.

  • Reduces the chance of pregnancy after unprotected sex
  • Not for regular birth control

Contains 1 Tablet, 1.5 mg

Note: This package in not child resistant. Keep this and all medication out of the reach of children.

Bionafem CartonBionafem Carton

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69452-24369452-243-60

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 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 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
A207044-001LEVONORGESTRELLEVONORGESTREL1.5MGTABLET / ORAL2016-03-25

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 22:38:342026-08A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-2584e616aacf4f…
2026-08-18 06:07:402026-07A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-2587673890dc5c…
2021-03-12 10:30 UTC2021-03A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-25c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-253f01610625f2…
2019-09-15 20:21 UTC2019-09A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-25b00525d2431f…
2019-07-19 19:46 UTC2019-07A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-25ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-253f0d92c62455…
2023-05-13 08:27 UTC2023-05A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-25053a50430f4f…
2023-01-26 05:58 UTC2023-01A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-253a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-25f41ea6bd6efb…

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
c8b9cd3b-341b-4021-e053-2995a90a5296b5eb3717-c2ab-4279-bce9-e3559c69e2bb2021-08-04WarningsExact identifier
spl set id: b5eb3717-c2ab-4279-bce9-e3559c69e2bb

Reported adverse events (FAERS/openFDA)#

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