EMERGENCY CONTRACEPTIVE- levonorgestrel tablet 
Cardinal Health (Leader) 70000

----------

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

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

Other information

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 PLAN B ONE-STEP® active ingredient*

Levonorgestrel Tablet 1.5 mg

Emergency Contraceptive

Reduces chances of pregnancy after unprotected sex

Not for regular birth control

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

One Tablet. One Step

Tablet

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

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

Package label

Levonorgestrel 1.5 mg

LEADER Emergency Contraceptive 1.5 mg

EMERGENCY CONTRACEPTIVE 
levonorgestrel tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0647(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
ColorwhiteScoreno score
ShapeROUNDSize6mm
FlavorImprint Code C;1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0647-11 in 1 CARTON09/15/2023
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20532909/15/2023
Labeler - Cardinal Health (Leader) 70000 (063997360)

Revised: 9/2023
Document Id: 69e7f90d-64f0-4a2e-80ba-e10221b3b2cb
Set id: 161dad29-54b0-4298-a022-b1e9f70af663
Version: 2
Effective Time: 20230928
 
Cardinal Health (Leader) 70000