Plan B One-Step

Label at a glance#

Contacts and useful links#

PhoneLabel contact1-800-330-1271

Websitewww.planbonestep.comwww.PlanBOneStep.com

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Levonorgestrel 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
• breast pain
• nausea
• headache
• vomiting
• lower stomach (abdominal) pain
• dizziness

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.

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
• do not use if carton is open or tear strip is removed or blister seal is broken or missing
• store at 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

Call 1-800-330-1271 or visit www.PlanBOneStep.com

SPL UNCLASSIFIED SECTION

Distributed by:
Foundation Consumer Healthcare, LLC. (FCH)
Pittsburgh, PA 15205

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-5978

NDC: 50090-5978-0 1 TABLET in a BLISTER PACK / 1 in a BOX, UNIT-DOSE

levonorgestrel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

• Plan B One-Step
• levonorgestrel
• SILICON DIOXIDE
• STARCH, POTATO
• MAGNESIUM STEARATE
• TALC
• STARCH, CORN
• LACTOSE MONOHYDRATE

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML

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Orange Book application contexts page 1 of 1 · 1 matching rows.

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Current product rows page 1 of 1 · 1 matching rows.

Observed Orange Book product history#

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Product history page 1 of 2 · 43 observed states.

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Reported adverse events (FAERS/openFDA)#

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