LEVONORGESTREL- levonorgestrel tablet 
Curae Pharma360 Inc.

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Levonorgestrel

Drug Facts

Active ingredient

Levonorgestrel 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 at 1-800-222-1222.

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 1-888-885-3054 Monday - Friday 9 AM - 5 PM EST

Manufactured for:
Curae Pharma360 Inc.
San Francisco, CA 94105
NDC 73358-911-01
Product made in Germany
Rev. September 2022

PRINCIPAL DISPLAY PANEL - 1.5 mg Tablet Blister Pack Carton

NDC 73358-911-01

Levonorgestrel Tablet
1.5 mg

Emergency Contraceptive

Curae™
Pharma360

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

ONE TABLET.
ONE STEP.

Contains 1 levonorgestrel tablet

PRINCIPAL DISPLAY PANEL - 1.5 mg Tablet Blister Pack Carton
LEVONORGESTREL 
levonorgestrel tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73358-911
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)  
Starch, Corn (UNII: O8232NY3SJ)  
Magnesium Stearate (UNII: 70097M6I30)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Fd&C Yellow No. 6 (UNII: H77VEI93A8)  
Product Characteristics
ColorORANGE (Light peach) Scoreno score
ShapeROUND (Round convex) Size8mm
FlavorImprint Code 17
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73358-911-011 in 1 CARTON10/17/2022
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20238010/17/2022
Labeler - Curae Pharma360 Inc. (080719852)
Registrant - Naari Pte. Limited (659345996)

Revised: 10/2022
Document Id: 962fb10f-2419-4aef-9966-ab5c27c46f3b
Set id: 620ce53a-819d-4556-9069-6f9f13dbc50b
Version: 1
Effective Time: 20221017
 
Curae Pharma360 Inc.