Plan B One-step®

SPL v5

SPL

SPL Set ID 6ce6b40e-14ac-47bd-a648-ddf9e452e559

Route

ORAL

Published

Effective Date 2023-01-31

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Levonorgestrel (1.5 mg)

Inactive Ingredients

Silicon Dioxide Starch, Potato Magnesium Stearate Talc Starch, Corn Lactose Monohydrate

Identifiers & Packaging

Pill Appearance

Imprint: G00 Shape: round Color: white Size: 8 mm Score: 1

Marketing Status

NDA Active Since 2018-05-10

Description

Drug Facts

Purpose

Emergency contraceptive

Medication Information

Purpose

Emergency contraceptive

Description

Drug Facts

Use

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

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control center right away.

Section 50567-7

When using this product you may have

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

Section 50568-5

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.

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

Do Not Use

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

Questions?

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

Allergy Alert

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

Active Ingredient

Levonorgestrel 1.5 mg

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

Sexually Transmitted Diseases (stds) Alert

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

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

Principal Display Panel 1.5 Mg Tablet Blister Pack Box Ndc 69536 162 88

NDC 69536-162-88

This item is

electronically

protected

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

Structured Label Content

Use

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control center right away.

Section 50567-7 (50567-7)

When using this product you may have

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

Section 50568-5 (50568-5)

Purpose

Emergency contraceptive

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

Do Not Use (Do not use)

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

Questions?

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

Allergy Alert (Allergy alert)

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

Active Ingredient (Active ingredient)

Levonorgestrel 1.5 mg

Other Information (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 (Inactive ingredients)

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

Sexually Transmitted Diseases (stds) Alert (Sexually transmitted diseases (STDs) alert)

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

Principal Display Panel 1.5 Mg Tablet Blister Pack Box Ndc 69536 146 19 (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

Principal Display Panel 1.5 Mg Tablet Blister Pack Box Ndc 69536 162 88 (PRINCIPAL DISPLAY PANEL - 1.5 mg Tablet Blister Pack Box - NDC 69536-162-88)

NDC 69536-162-88

This item is

electronically

protected

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

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Use": "for women to reduce chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use birth control)", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control center right away.", "50567-7": "When using this product you may have menstrual changes tiredness breast pain nausea headache vomiting lower stomach (abdominal) pain dizziness", "50568-5": "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.", "Purpose": "Emergency contraceptive", "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", "Do not use": "if you are already pregnant (because it will not work) for regular birth control", "Questions?": "Call 1-800-330-1271 or visit www.PlanBOneStep.com", "Allergy alert": "Do not use if you have ever had an allergic reaction to levonorgestrel", "Active ingredient": "Levonorgestrel 1.5 mg", "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", "Sexually transmitted diseases (STDs) alert": "This product does not protect against HIV/AIDS or other STDs", "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", "PRINCIPAL DISPLAY PANEL - 1.5 mg Tablet Blister Pack Box - NDC 69536-162-88": "NDC 69536-162-88 This item is electronically protected 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"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:30.900288 · Updated: 2026-03-14T23:00:58.722463