Curae

Manufacturer
Curae Pharma360 Inc. | Naari Pte. Limited
Effective date
2024-10-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 20:50:33

Label at a glance#

ProductCurae
Active ingredientLevonorgestrel
Label structure11 sections

Dosage and administration

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 of taking the medication, call a healthcare professional to find out if you should repeat the dose

Storage and handling

read the instructions, warnings, and enclosed product leaflet before use do not use if carton is open or blister seal is broken or missing store at 20° to 25°C (68° to 77°F)

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

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 1-800-222-1222

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 of 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 blister seal is broken or missing
  • store at 20° to 25°C (68° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, FD&C Yellow No.6 aluminum lake, lactose monohydrate, magnesium stearate, and pregelatinized starch

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-888-885-3054
Monday - Friday 9 AM - 5 PM EST

SPL UNCLASSIFIED SECTION

Manufactured for:
Curae Pharma360 Inc.
San Francisco, CA 94105
NDC 73358-241-01
Product made in Germany
Issued: March 2023

PRINCIPAL DISPLAY PANEL - 1.5 mg Tablet Blister Pack Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 73358-241-01

Curae™

Levonorgestrel Tablet 1.5 mg

EMERGENCY CONTRACEPTIVE

REDUCES CHANCE OF PREGNANCY
AFTER UNPROTECTED SEX

NOT FOR REGULAR BIRTH CONTROL

  • The sooner you take it, the more effective it will be
  • Take as soon as possible within 72 hours (3 days)
    after unprotected sex
  • Will not harm an existing pregnancy

ONE TABLET. ONE STEP.

Principal Display Panel - 1.5 mg Tablet Blister Pack Carton
Principal Display Panel - 1.5 mg Tablet Blister Pack Carton

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73358-241-01EA - Each73358-241bd26bdba-73fc-4612-be01-61ca32fe24c412023-06-06

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73358-24173358-241-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b0662a56-e26a-45bd-8109-06fb7608bd6e0bd6ec93-795e-4e40-96d6-41c4cae035d92025-03-06WarningsExact identifier
spl set id: 0bd6ec93-795e-4e40-96d6-41c4cae035d9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.