Levonorgestrel

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Levonorgestrel, USP 1.5 mg

Purpose

OTC - PURPOSE SECTION

Emergency contraceptive

Use

INDICATIONS & USAGE SECTION

for women to reduce chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use birth control)

Warnings

WARNINGS SECTION

Allergy alert

SPL UNCLASSIFIED SECTION

Do not use if you have ever had an allergic reaction to levonorgestrel

Sexually transmitted diseases (STDs) alert

SPL UNCLASSIFIED SECTION

This product does not protect against HIV/AIDS or other STDs.

Do not use

OTC - DO NOT USE SECTION

• if you are already pregnant (because it will not work)
• for regular birth control

OTC - ASK DOCTOR/PHARMACIST SECTION

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.

OTC - WHEN USING SECTION

When using this product you may have

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

• 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

STORAGE AND HANDLING SECTION

• 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

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, corn starch, hypromellose, lactose monohydrate, magnesium stearate, talc

Questions or comments?

OTC - QUESTIONS SECTION

For more information, call toll free 1-800-818-4555 weekdays

SPL UNCLASSIFIED SECTION

Distributed by:
Rugby Laboratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152

PRINCIPAL DISPLAY PANEL - 1.5 mg Tablet Blister Pack Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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.

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• Levonorgestrel
• silicon dioxide
• starch, corn
• hypromellose, unspecified
• lactose monohydrate
• magnesium stearate
• talc

NDC Codes#

Ingredients#

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Observed Orange Book product history#

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Product history page 1 of 2 · 43 observed states.

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