EMERGENCY CONTRACEPTIVE- levonorgestrel tablet 
Rugby Laboratories, Inc.

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EContra One-Step®
(Levonorgestrel)  Tablet 1.5 mg

Active ingredient ( in each tablet)

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

Ask a doctor or pharmacist before use if you are

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

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

Keep out of reach children.

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

croscarmellose sodium, lactose 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**

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

Levonorgestrel 1.5 mg

RUGBY Emergency Contraceptive

EMERGENCY CONTRACEPTIVE 
levonorgestrel tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1391(NDC:70700-164)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW) LEVONORGESTREL1.5 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLOXAMER 188 (UNII: LQA7B6G8JG)  
Product Characteristics
Colorwhite (White to off-white) Scoreno score
ShapeROUNDSize6mm
FlavorImprint Code C;1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1391-631 in 1 CARTON08/01/202311/16/2023
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20532908/01/202311/16/2023
Labeler - Rugby Laboratories, Inc. (079246066)

Revised: 2/2024
Document Id: 34df43e3-35bf-4d94-99cd-5ace15efa357
Set id: 4950fb25-042c-46d4-84ba-fe7f47011882
Version: 2
Effective Time: 20240208
 
Rugby Laboratories, Inc.