LEADER EMERGENCY CONTRACEPTIVE LEVONORGESTREL- levonorgestrel tablet 
Cardinal Health 110, LLC. DBA Leader

----------

LEADER

Drug Facts

Active ingredient

Levonorgestrel, USP 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 medications may reduce the effectiveness of levonorgestrel.

When using this product you may have

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

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

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 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

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

Questions or comments?

For more information, call toll free 1-800-406-7984 weekdays

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017

PRINCIPAL DISPLAY PANEL - 1.5 mg Tablet Blister Pack Carton

LEADER

NDC 70000-0600-1

Levonorgestrel

Tablet, 1.5 mg
Emergency Contraceptive

Reduces the Chance 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

COMPARE TO
PLAN B ONE-STEP®
active ingredient

100% Money
Back Guarantee

1 LEVONORGESTREL TABLET

SEE NEW WARNING

PRINCIPAL DISPLAY PANEL - 1.5 mg Tablet Blister Pack Carton
LEADER EMERGENCY CONTRACEPTIVE LEVONORGESTREL 
levonorgestrel tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0600
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW) LEVONORGESTREL1.5 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorWHITE (white to off-white) Scoreno score
ShapeROUND (circular) Size8mm
FlavorImprint Code 718
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0600-11 in 1 CARTON03/22/2022
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20263503/22/2022
Labeler - Cardinal Health 110, LLC. DBA Leader (063997360)
Establishment
NameAddressID/FEIBusiness Operations
Sun Pharmaceutical Industries Limited725959238MANUFACTURE(70000-0600)

Revised: 6/2022
Document Id: 22674ee5-1f31-4caa-aaed-96d3dd6d1b2f
Set id: d1e33615-0a98-4223-833d-843c758d9db7
Version: 4
Effective Time: 20220620
 
Cardinal Health 110, LLC. DBA Leader