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SheWise

levonorgestrel · SheWise is a progestin (over-the-counter) containing levonorgestrel, made by GLENMARK THERAPEUTICS INC., USA.

Type
Over the counter
Drug class
Progestin
Route
Oral
Manufacturers
1

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

Related recalls

FDA drug recalls that name this drug or its active ingredient

All drug recalls

Active ingredients

Levonorgestrel, USP 1.5mg

Purpose

Emergency contraceptive

Uses

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

Directions

When should I use Levonorgestrel Tablet? The sooner you take emergency contraception, the better it works. You should use Levonorgestrel Tablet within 72 hours (3 days) after you have had unprotected sex. Levonorgestrel Tablet is a backup or emergency method of birth control you can use when:

  • Your regular birth control was used incorrectly or failed
  • You did not use any birth control method

Warnings

Allergy alert: Do not use if you have ever had an allergic reaction to Levonorgestrel. Sexually transmitted disease (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

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
  • Nausea
  • Lower stomach (abdominal) pain
  • Tiredness
  • Headache
  • Breast pain
  • Vomiting
  • Dizziness

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center right away.

Other information

Store at room temperature, 20°C to 25°C (68°F to 77°F). Active ingredient: Levonorgestrel, USP 1.5 mg Inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, potato starch, talc. If you are sexually active, you should see a healthcare provider for routine checkups. Your healthcare provider will talk to you about and, if necessary, test you for sexually transmitted diseases, teach you about effective methods of routine birth control, and answer any other questions you may have. Manufactured by: Glenmark Pharmaceuticals Limited Colvale-Bardez, Goa 403513, India Questions? 1 (888) 721-7115 www.glenmarkpharma-us.com July 2025

Inactive ingredients

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

Questions?

Call 1 (888) 721-7115 or visit www.glenmarkpharma-us.com

Forms and strengths

From the FDA NDC Directory · 1 product codes

Dosage formStrengthRouteNDCs
Tablet1.5 mgoral1

Side effect reports to FDA

FDA Adverse Event Reporting System (FAERS), 200,217 reports that list levonorgestrel, data through 07/30/2026

Anyone can report a problem to FDA, and a report does not mean the drug caused the problem. Reports can be duplicated or incomplete, and counts depend on how widely a drug is used. Do not stop or change a medicine because of this list. Talk to your doctor or pharmacist.

Most often reported reactions

  • Device expulsion45,531
  • Device dislocation20,439
  • Menstruation irregular15,018
  • Vaginal hemorrhage14,925
  • Genital hemorrhage11,130
  • Abdominal pain lower9,293
  • Abdominal pain8,592
  • Nausea8,519
  • Procedural pain8,456
  • Pain7,528

To report a side effect, use FDA MedWatch.

Manufacturers and labels

1 FDA label

  • GLENMARK THERAPEUTICS INC., USAShown hereANDA207044 · Label 07/15/2026 · NDC 72657-108Full label

SheWise: common questions

What is SheWise used for?
Use for women to reduce chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use birth control)
Is SheWise a prescription drug?
No. SheWise is sold over the counter (OTC) without a prescription.
Are there other products with the same active ingredient as SheWise?
Yes. Other FDA-listed products with the same active ingredients include Levonorgestrel, My Way, Julie, Julie Morning After Pill.
Who makes SheWise?
GLENMARK THERAPEUTICS INC., USA lists SheWise with the FDA.

Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 07/15/2026 · Label text is shown as published by the manufacturer. Not medical advice

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