LEVONORGESTREL- levonorgestrel tablet 
H.J. Harkins Company, Inc.

----------

1164 LEVONORGESTREL

Levonorgestrel USP 1.5 mg

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).

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

Keep out of the reach of children.

In case of overdose, get medical help or contact a Poison Control center 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 attachment of a fertilized egg to the uterus (implantation).
Do not use if carton is open or blister seal is broken or missing .
store at 25°C (77°C); excursions permitted to 15 to 30°C (59 to 86°C) [see USP Controlled Room temperature].

colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, and povidone.

Label

LEVONORGESTREL 
levonorgestrel tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76519-1164
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW) LEVONORGESTREL1.5 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POVIDONE K30 (UNII: U725QWY32X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize9mm
FlavorImprint Code LU;S25
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76519-1164-01 in 1 BOX; Type 0: Not a Combination Product11/15/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20144611/15/2017
Labeler - H.J. Harkins Company, Inc. (147681894)
Establishment
NameAddressID/FEIBusiness Operations
H.J. Harkins Company, Inc.147681894manufacture(76519-1164) , relabel(76519-1164) , repack(76519-1164)

Revised: 9/2019
Document Id: 92dcd064-5da0-29b6-e053-2a95a90a1bf1
Set id: 92dcd064-5d9f-29b6-e053-2a95a90a1bf1
Version: 1
Effective Time: 20190918
 
H.J. Harkins Company, Inc.