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.

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
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

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

Questions?

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

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

HOW SUPPLIED

Product: 50090-5978

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

levonorgestrel

PLAN B ONE-STEP
levonorgestrel tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50090-5978(NDC:69536-162)
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, POTATO (UNII: 8I089SAH3T)
MAGNESIUM STEARATE (UNII: 70097M6I30)
TALC (UNII: 7SEV7J4R1U)
STARCH, CORN (UNII: O8232NY3SJ)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	G00
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:50090-5978-0	1 in 1 BOX, UNIT-DOSE	05/05/2022
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA021998	05/10/2018

Labeler - A-S Medication Solutions (830016429)

Name	Address	ID/FEI	Business Operations
Establishment
A-S Medication Solutions		830016429	RELABEL(50090-5978)

Plan B One-Step®