LEVONORGESTREL- levonorgestrel tablet 
Rugby Laboratories

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Levonorgestrel

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 1-800-818-4555 weekdays

Distributed by:
Rugby Laboratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152

PRINCIPAL DISPLAY PANEL - 1.5 mg Tablet Blister Pack Carton

NDC 0536-1142-63

Rugby®

COMPARE TO
active ingredient in
PLAN B ONE-STEP®†

See New Warning

Levonorgestrel Tablet

1.5 mg

Emergency Contraceptive

Reduces the chance of pregnancy after unprotected sex
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
Not for regular birth control

1 Tablet Levonorgestrel 1.5 mg

ONE TABLET. ONE STEP.

PRINCIPAL DISPLAY PANEL - 1.5 mg Tablet Blister Pack Carton
LEVONORGESTREL 
levonorgestrel tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1142
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
ColorWHITEScoreno score
ShapeROUNDSize8mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1142-631 in 1 CARTON11/01/2017
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20263511/01/2017
Labeler - Rugby Laboratories (079246066)
Establishment
NameAddressID/FEIBusiness Operations
Sun Pharmaceutical Industries Limited725959238MANUFACTURE(0536-1142)

Revised: 4/2018
Document Id: bea85d01-936e-46f6-8037-b60d0e39dd05
Set id: bea85d01-936e-46f6-8037-b60d0e39dd05
Version: 1
Effective Time: 20180411
 
Rugby Laboratories