Econtra One-step®

Econtra One-step®
SPL v3
SPL
SPL Set ID 25676fc2-1f1f-40d2-8e84-3e52c8abda49
Route
ORAL
Published
Effective Date 2023-06-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Levonorgestrel (1.5 mg)
Inactive Ingredients
Croscarmellose Sodium Lactose Monohydrate Magnesium Stearate Microcrystalline Cellulose Poloxamer 188

Identifiers & Packaging

Pill Appearance
Imprint: C;1 Shape: round Color: white Size: 6 mm Score: 1
Marketing Status
ANDA Active Since 2023-08-01

Description

Levonorgestrel 1.5 mg

Purpose

Emergency contraceptive


Medication Information

Purpose

Emergency contraceptive

Description

Levonorgestrel 1.5 mg

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

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.
Do Not Use
  • if you are already pregnant (because it will not work)
  • for regular birth control 
Package Label
READYinCASE Emergency Contraceptive
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 release egg (joining of sperm and egg) or attachment of 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

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

Questions Or Comments?

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

Principal Display Panel

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

emergency contraceptive

levonorgestrel

Tablet 1.5 mg

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

reduces chance of pregnancy after unprotected sex not for regular birth control

tablet 1.5 mg

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

Distributed by:

PL Developments

200 Hicks Street

Westbury, NY 11590

Keep Out of Reach of Children

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

Active Ingredient (in Each Tablet)

Levonorgestrel 1.5 mg

When Using This Product You May Have
  • menstrual changes
  • tiredness
  • breast pain
  • nausea
  • headache
  • vomiting
  • lower stomach (abdominal) pain
  • dizziness
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.


Structured Label Content

Use

for women to reduce chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use birth control)

Purpose

Emergency contraceptive

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

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.
Do Not Use (Do not use)
  • if you are already pregnant (because it will not work)
  • for regular birth control 
Package Label
READYinCASE Emergency Contraceptive
Other Information (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 release egg (joining of sperm and egg) or attachment of 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 ingredients)

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

Questions Or Comments? (Questions or comments?)

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

Principal Display Panel (Principal display panel)

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

emergency contraceptive

levonorgestrel

Tablet 1.5 mg

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

reduces chance of pregnancy after unprotected sex not for regular birth control

tablet 1.5 mg

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

Distributed by:

PL Developments

200 Hicks Street

Westbury, NY 11590

Keep Out of Reach of Children (Keep out of reach of children)

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

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Levonorgestrel 1.5 mg

When Using This Product You May Have (When using this product you may have)
  • menstrual changes
  • tiredness
  • breast pain
  • nausea
  • headache
  • vomiting
  • lower stomach (abdominal) pain
  • dizziness
Ask A Doctor Or Pharmacist Before Use If You Are (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.


Advanced Ingredient Data


Raw Label Data

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