Levonorgestrel by Rugby Laboratories / Sun Pharmaceutical Industries Limited LEVONORGESTREL tablet

Levonorgestrel by

Drug Labeling and Warnings

Levonorgestrel by is a Otc medication manufactured, distributed, or labeled by Rugby Laboratories, Sun Pharmaceutical Industries Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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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

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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.

INGREDIENTS AND APPEARANCE

LEVONORGESTREL 
levonorgestrel tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1142
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
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
Color	WHITE	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-1142-63	1 in 1 CARTON	11/01/2017
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	ANDA202635	11/01/2017

Labeler - Rugby Laboratories (079246066)

Establishment
Name	Address	ID/FEI	Business Operations
Sun Pharmaceutical Industries Limited		725959238	MANUFACTURE(0536-1142)