Levonorgestrel by Curae Pharma360 Inc. / Naari Pte. Limited LEVONORGESTREL tablet

Levonorgestrel by

Drug Labeling and Warnings

Levonorgestrel by is a Otc medication manufactured, distributed, or labeled by Curae Pharma360 Inc., Naari Pte. Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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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

• 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 of 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 20° to 25°C (68° to 77°F)

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

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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.

• 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

ONE TABLET.
ONE STEP.

Contains 1 levonorgestrel tablet

INGREDIENTS AND APPEARANCE

LEVONORGESTREL 
levonorgestrel tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73358-911
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Levonorgestrel (UNII: 5W7SIA7YZW) (Levonorgestrel - UNII:5W7SIA7YZW)	Levonorgestrel	1.5 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	ORANGE (Light peach)	Score	no score
Shape	ROUND (Round convex)	Size	8mm
Flavor		Imprint Code	17
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73358-911-01	1 in 1 CARTON	10/17/2022	02/28/2025
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA202380	10/17/2022	02/28/2025

Labeler - Curae Pharma360 Inc. (080719852)

Registrant - Naari Pte. Limited (659345996)