Rogaine Extra Strength is used to help you regrow hair on your scalp.

Rogaine Extra Strength will not cause permanent regrowth of scalp hair. You must continue using the product to keep the regrowth of your hair.

Rogaine Extra Strength may also be used for purposes not listed in this medication guide.

Do not use Rogaine Extra Strength if the skin on your scalp is red, swollen, irritated, or infected.

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Using more of this medicine than recommended will not speed up hair growth, and may cause dangerous side effects.

This medicine comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Dry your hair and scalp before applying Rogaine Extra Strength.

Apply the recommended amount to the affected areas of the scalp. Rogaine Extra Strength is usually applied twice daily, in the morning and at night.

Wash your hands after applying Rogaine Extra Strength.

Use Rogaine Extra Strength only on your scalp. Do not use on any other part of your body.

It may take up to 4 months or longer before you notice new hair growth. New hair may be soft, colorless, and barely visible. With further treatment, the hair should begin to have the same color and thickness as your existing hair.

Talk to your doctor if you do not see any hair growth after 4 months of treatment.

Store at room temperature away from moisture and heat.

Keep the Rogaine Extra Strength foam canister away from open flame or high heat, such as in a car on a hot day. The canister may explode if it gets too hot. Do not puncture or burn an empty canister.

Do not use Rogaine Extra Strength if the skin on your scalp is red, swollen, irritated, or infected. This may allow more of the medication to be absorbed by your body, which could be dangerous.

Check the medicine label carefully to make sure Rogaine Extra Strength will treat your specific type of hair loss.

Use only the Rogaine Extra Strength formula that is made for your gender. Women should not use this medicine products that are made specifically for men.

Ask a doctor or pharmacist if it is safe for you to use Rogaine Extra Strength if you have other medical conditions, especially:

• heart disease.

FDA pregnancy category C. It is not known whether Rogaine Extra Strength will harm an unborn baby. Do not use this medicine without a doctor's advice if you are pregnant.

It is not known whether minoxidil topical passes into breast milk or if it could harm a nursing baby. Do not use this medicine without a doctor's advice if you are breast-feeding a baby.

Do not use this medicine on anyone under 18 years old without medical advice.

Apply the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next dose. Do not use extra medicine to make up the missed dose.

An overdose of Rogaine Extra Strength is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

Avoid getting Rogaine Extra Strength in the eyes, nose, or mouth. If this occurs, rinse the area with water.

Avoid using other skin products on the areas you treat with Rogaine Extra Strength, unless your doctor tells you to.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Although the risk of serious side effects is low when Rogaine Extra Strength is applied to the skin, side effects can occur if the medicine is absorbed into your bloodstream.

Rogaine Extra Strength may cause serious side effects. Call your doctor at once if you have:

• severe scalp irritation;

• unwanted growth of facial hair;

• chest pain, fast heartbeats;

• swelling in your hands or feet, rapid weight gain;

• a light-headed feeling, like you might pass out;

• headache, dizziness, confusion; or

• flushing (warmth, redness, or tingly feeling).

Common side effects of Rogaine Extra Strength may include:

• changes in the color or texture of your hair.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

It is not likely that other drugs you take orally or inject will have an effect on topically applied minoxidil. But many drugs can interact with each other. Tell each of your health care providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.