PLAN B ONE-STEP- levonorgestrel tablet

Plan B One-Step by

Drug Labeling and Warnings

Plan B One-Step by is a Otc medication manufactured, distributed, or labeled by Foundation Consumer Healthcare LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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
• 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 20-25°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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 1.5 mg Tablet Blister Pack Box - NDC:

69536-162-88

NDC: 69536-162-88

Plan B
One-Step®

levonorgestrel 1.5 mg

emergency contraceptive

Reduces chance of
pregnancy after
unprotected sex.
Not for regular birth control.

One Tablet.
One Step.

1 Tablet Levonorgestrel 1.5 mg

PRINCIPAL DISPLAY PANEL - 1.5 mg Tablet Blister Pack Box - NDC:

69536-146-19

FOR CLINIC USE ONLY.
NOT FOR RETAIL SALE.

NDC: 69536-146-19

Plan B
One-Step®

levonorgestrel 1.5 mg

emergency contraceptive

Reduces chance of
pregnancy after
unprotected sex.
Not for regular birth control.

One Tablet.
One Step.

1 Tablet Levonorgestrel 1.5 mg

INGREDIENTS AND APPEARANCE

PLAN B ONE-STEP 
levonorgestrel tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69536-162
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, 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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69536-162-88	1 in 1 BOX, UNIT-DOSE	05/10/2018
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 69536-162-99	1 in 1 BOX, UNIT-DOSE	08/15/2019
2		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
NDA	NDA021998	05/10/2018

PLAN B ONE-STEP 
levonorgestrel tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69536-146
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, 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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69536-146-19	1 in 1 BOX, UNIT-DOSE	05/10/2018
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
NDA	NDA021998	05/10/2018

Labeler - Foundation Consumer Healthcare LLC (079675882)