LEVONORGESTREL- levonorgestrel tablet 
Ohm Laboratories Inc.

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

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

Other information

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:
Ohm Laboratories Inc.
New Brunswick, NJ 08901

PRINCIPAL DISPLAY PANEL - 1.5 mg Tablet Blister Pack Carton

FDA
APPROVED

NDC 51660-999-11

YOUR
CHOICE™

LEVONORGESTREL TABLET 1.5 MG

EMERGENCY
CONTRACEPTIVE

Reduces the chance of
pregnancy after
unprotected sex
NOT FOR REGULAR
BIRTH CONTROL

ONE STEP

Contains 1 Tablet Levonorgestrel 1.5 mg

Principal Display Panel - 1.5 mg Tablet Blister Pack Carton
LEVONORGESTREL 
levonorgestrel tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51660-999
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:51660-999-111 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 - Ohm Laboratories Inc. (184769029)
Establishment
NameAddressID/FEIBusiness Operations
Sun Pharmaceutical Industries Limited725959238MANUFACTURE(51660-999)

Revised: 2/2024
Document Id: ad12529c-11f3-433a-b593-e910d04bfa23
Set id: f3f2a41a-a9af-4d63-81d8-33181d12af40
Version: 2
Effective Time: 20240216
 
Ohm Laboratories Inc.