LEVONORGESTREL- levonorgestrel tablet 
OC Pharma, LLC

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Levonorgestrel Tablets

Drug Facts

Active ingredient

Levonorgestrel 1.5mg

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

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.

Directions

Other information

Inactive ingredients

colloidal silicon dioxide, FD&C Yellow No.6 aluminum lake, lactose monohydrate, magnesium stearate, and pregelatinized starch

Questions or comments?

Call 1-800-224-4606.

PRINCIPAL DISPLAY PANEL - 1.5 mg Tablet Blister Pack Carton

NDC 49615-017-01

Levonorgestrel Tablet

1.5 mg

Emergency Contraceptive

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

ONE TABLET. ONE DOSE.

OC
Pharma

Contains 1 Levonorgestrel Tablet 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:49615-017
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)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Lactose Monohydrate (UNII: EWQ57Q8I5X)  
Magnesium Stearate (UNII: 70097M6I30)  
Starch, corn (UNII: O8232NY3SJ)  
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize8mm
FlavorImprint Code 17
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49615-017-011 in 1 CARTON12/31/2018
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20238012/01/2018
Labeler - OC Pharma, LLC (171268936)

Revised: 10/2017
Document Id: 80b385e7-fe59-49b4-9de2-3c1ce3694cca
Set id: c7698816-6ac6-48c6-aaff-c484ebbafed3
Version: 1
Effective Time: 20171026
 
OC Pharma, LLC