Plan B One-step®

SPL v3

SPL

SPL Set ID fcc7ba8e-ad54-4efe-87e4-5eb0fbf4f064

Route

ORAL

Published

Effective Date 2023-10-24

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

How Supplied

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

Medication Information

Purpose

Emergency contraceptive

How Supplied

Product: 50090-5978

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

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

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

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

How Supplied (HOW SUPPLIED)

Product: 50090-5978

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

Allergy Alert (Allergy alert)

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

Levonorgestrel (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

Advanced Ingredient Data

[{"name": "LEVONORGESTREL", "unii": "5W7SIA7YZW", "classCode": "ACTIB", "strengthNumerator": "1.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, POTATO", "unii": "8I089SAH3T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TALC", "unii": "7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

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", "HOW SUPPLIED": "Product: 50090-5978 NDC: 50090-5978-0 1 TABLET in a BLISTER PACK / 1 in a BOX, UNIT-DOSE", "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"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:01:42.643281 · Updated: 2026-03-14T23:01:30.191020