Generic Name: Carbetapentane/Guaifenesin (car-bay-ta-PEN-tane/gwye-FEN-e-sin)
Brand Name: Examples include Allfen CX and Xpect-AT

Xpect-AT Sustained-Release Tablets are used for:

Relieving unproductive cough and reducing mucus in the chest due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Xpect-AT Sustained-Release Tablets are a cough suppressant and expectorant combination. The cough suppressant works in the brain to help decrease the cough reflex. The expectorant works by thinning mucus (phlegm) in the lungs, making it less sticky and easier to cough up. This makes coughs more productive.

Do NOT use Xpect-AT Sustained-Release Tablets if:

• you are allergic to any ingredient in Xpect-AT Sustained-Release Tablets
• the patient is a newborn or infant
• you have taken a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the past 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Xpect-AT Sustained-Release Tablets:

Some medical conditions may interact with Xpect-AT Sustained-Release Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have chronic cough due to smoking, asthma, chronic bronchitis, or emphysema, or if your cough produces large amounts of mucus
• if you have a history of heart or blood vessel problems, high blood pressure, prostate problems, an overactive thyroid, diabetes, or glaucoma

Some MEDICINES MAY INTERACT with Xpect-AT Sustained-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

• MAOIs (eg, phenelzine) because the risk of their side effects may be increased by Xpect-AT Sustained-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Xpect-AT Sustained-Release Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Xpect-AT Sustained-Release Tablets:

Use Xpect-AT Sustained-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Xpect-AT Sustained-Release Tablets by mouth with or without food.
• Drinking extra fluids while you are taking Xpect-AT Sustained-Release Tablets are recommended. Check with your doctor for instructions.
• Swallow Xpect-AT Sustained-Release Tablets whole. Do not break, crush, or chew before swallowing. Some brands of Xpect-AT Sustained-Release Tablets may be broken in half before taking. If you have difficulty swallowing the whole tablet, ask your pharmacist if your brand of medicine may be broken in half.
• If you miss a dose of Xpect-AT Sustained-Release Tablets and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Xpect-AT Sustained-Release Tablets.

Important safety information:

• Xpect-AT Sustained-Release Tablets may cause drowsiness. This effect may be worse if you take it with alcohol or certain medicines. Use Xpect-AT Sustained-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Xpect-AT Sustained-Release Tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Do not use Xpect-AT Sustained-Release Tablets for a cough with a lot of mucous. Do not use it for a long-term cough (eg, caused by asthma, emphysema, smoking). However, you may use it for these conditions if your doctor tells you to.
• If cough persists for more than 1 week or is accompanied by a fever, contact your health care provider. A persistent cough could be a sign of a serious condition.
• Xpect-AT Sustained-Release Tablets should not be used in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Xpect-AT Sustained-Release Tablets while you are pregnant. It is not known if Xpect-AT Sustained-Release Tablets are found in breast milk. If you are or will be breast-feeding while you take Xpect-AT Sustained-Release Tablets, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Xpect-AT Sustained-Release Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Drowsiness; dry mouth, nose, or throat; upset stomach.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch .

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include restlessness; seizures; severe agitation.

Proper storage of Xpect-AT Sustained-Release Tablets:

Store Xpect-AT Sustained-Release Tablets between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Xpect-AT Sustained-Release Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Xpect-AT Sustained-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
• Xpect-AT Sustained-Release Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Xpect-AT Sustained-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Generic Name: Levalbuterol (lev-al-BYOO-ter-ol)
Brand Name: Xopenex HFA

Xopenex HFA Aerosol is used for:

Treating and preventing breathing problems in patients who have asthma or certain airway diseases. It may also be used for other conditions as determined by your doctor.

Xopenex HFA Aerosol is a sympathomimetic (beta-agonist) bronchodilator. It works by relaxing the smooth muscle in the airway, which allows air to flow in and out of the lungs more easily.

Do NOT use Xopenex HFA Aerosol if:

• you are allergic to any ingredient in Xopenex HFA Aerosol or to albuterol

Contact your doctor or health care provider right away if any of these apply to you.

Before using Xopenex HFA Aerosol:

Some medical conditions may interact with Xopenex HFA Aerosol. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a history of heart problems (eg, fast or irregular heartbeat, low blood output), blood vessel problems, high blood pressure, or low blood potassium levels
• if you have a history of seizures, diabetes, overactive thyroid, kidney problems, or adrenal gland tumor (pheochromocytoma)
• if you have ever had an unusual reaction to another sympathomimetic medicine (eg, pseudoephedrine)
• if you are taking a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) or tricyclic antidepressant (eg, amitriptyline), or if you have taken either of these within the last 14 days

Some MEDICINES MAY INTERACT with Xopenex HFA Aerosol. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Diuretics (eg, furosemide, hydrochlorothiazide) because the risk of low blood potassium levels may be increased
• Catechol-O-methyltransferase (COMT) inhibitors (eg, entracapone), epinephrine, MAOIs (eg, phenelzine), short-acting sympathomimetic bronchodilators (eg, metaproterenol), stimulants (eg, amphetamine), sympathomimetics (eg, pseudoephedrine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Xopenex HFA Aerosol’s side effects
• Beta-blockers (eg, propranolol) because they may decrease Xopenex HFA Aerosol’s effectiveness
• Digoxin because its effectiveness may be decreased by Xopenex HFA Aerosol

This may not be a complete list of all interactions that may occur. Ask your health care provider if Xopenex HFA Aerosol may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Xopenex HFA Aerosol:

Use Xopenex HFA Aerosol as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Xopenex HFA Aerosol. Talk to your pharmacist if you have questions about this information.
• Prime the inhaler before you use it for the first time. To prime it, spray 4 test sprays into the air, away from your face. You will need to reprime the inhaler any time it has not been used for longer than 3 days.
• Before using Xopenex HFA Aerosol, be sure that the canister is properly placed in the inhaler unit. Shake well before each dose. Breathe out slowly and completely. Place the mouthpiece between your lips and try to rest your tongue flat, unless your doctor has told you otherwise. Your doctor may have told you to hold the inhaler 1 to 2 inches (2 or 3 centimeters) away from the open mouth or to use a special spacing device. As you start to take a slow, deep breath, press the canister and mouthpiece together at exactly the same time. This will release a dose of Xopenex HFA Aerosol. Continue breathing in slowly and deeply and hold for 10 seconds or as long as comfortable, then breathe out slowly through pursed lips or your nose. If more than 1 inhalation is to be used, wait a few minutes and repeat the above steps. Keep the spray away from your eyes.
• Replace the cap on the mouthpiece after each use
• Clean the plastic mouthpiece and cap at least once a week to prevent blockage. Remove the metal canister. Rinse in warm running water for at least 30 seconds. Shake off excess water, and then allow the mouthpiece to air dry completely (eg, overnight). After the plastic case and cap dry, replace the canister. Place the cap back on the mouthpiece. Do NOT allow the metal canister to become wet.
• If you must use the inhaler before it is completely dry, shake the excess water off of the plastic mouthpiece. Insert the canister into the plastic case, shake well, and spray 2 times into the air, away from yourself and others. You may then use a dose. After your dose, rewash the plastic case and air dry completely.
• If the inhaler becomes blocked, wash the plastic case as directed.
• This inhaler contains 200 sprays. Do not use this inhaler after 200 sprays have been used. It may not give the correct amount of medicine with each spray.
• Do not use Xopenex HFA Aerosol with any other mouthpiece. Do not use this mouthpiece with any other medicine.
• If you miss a dose of Xopenex HFA Aerosol and you are using it regularly, use it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Xopenex HFA Aerosol.

Important safety information:

• Xopenex HFA Aerosol may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Xopenex HFA Aerosol with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Xopenex HFA Aerosol may sometimes cause severe breathing problems right after you use a dose. When this problem occurs, it is often after the first use of a new canister. If this happens, seek medical care at once.
• If your usual dose does not work well, your symptoms become worse, or you need to use it more often than normal, contact your doctor at once. This may be a sign of seriously worsening asthma. Your doctor may need to change your dose or medicine.
• Xopenex HFA Aerosol should work for up to 4 to 6 hours. Do NOT use more than the recommended dose or use more often than prescribed without checking with your doctor. The risk of severe heart problems and sometimes death may be increased with overuse of Xopenex HFA Aerosol.
• Talk with your doctor or pharmacist about all of your asthma medicines and how to use them. Do not start, stop, or change the dose of any asthma medicine unless your doctor tells you to.
• Xopenex HFA Aerosol may cause dry mouth or an unpleasant taste in your mouth. Rinsing your mouth with water after each dose may help relieve these effects.
• Tell your doctor or dentist that you take Xopenex HFA Aerosol before you receive any medical or dental care, emergency care, or surgery.
• Keep track of how many inhalations you use. When your medicine supply begins to run low, call your doctor or pharmacy as soon as possible for a refill.
• Do NOT place the canister in water to try to determine how much medicine you have left.
• The contents of this canister are under pressure. Do NOT store or use Xopenex HFA Aerosol near an open flame. Do NOT puncture, break, or burn the container, even if it appears empty.
• Diabetes patients – Xopenex HFA Aerosol may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Lab tests, including lung function, may be performed while you use Xopenex HFA Aerosol. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Xopenex HFA Aerosol with caution in the ELDERLY; they may be more sensitive to its effects.
• Caution is advised when using Xopenex HFA Aerosol in CHILDREN; they may experience vomiting with use of Xopenex HFA Aerosol. Safety and effectiveness in children younger than 4 years old have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Xopenex HFA Aerosol while you are pregnant. It is not known if Xopenex HFA Aerosol is found in breast milk. If you are or will be breast-feeding while you use Xopenex HFA Aerosol, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Xopenex HFA Aerosol:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; dry mouth; nervousness; runny or stuffy nose; sore or dry throat; tremor.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; fast or irregular heartbeat; new or worsening wheezing, coughing, or trouble breathing; severe headache or dizziness; severe or persistent trouble sleeping; sudden shortness of breath; unusual hoarseness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include chest pain; dizziness; fast or irregular heartbeat; seizures; severe or persistent dizziness or headache; severe or persistent nervousness, tremor, or trouble sleeping.

Proper storage of Xopenex HFA Aerosol:

Store Xopenex HFA Aerosol upright between 68 and 77 degrees F (20 and 25 degrees C). Store with the mouthpiece down. Do not freeze. Avoid temperatures above 120 degrees F (48 degrees C). Store away from heat and direct sunlight. Keep Xopenex HFA Aerosol out of the reach of children and away from pets.

General information:

• If you have any questions about Xopenex HFA Aerosol, please talk with your doctor, pharmacist, or other health care provider.
• Xopenex HFA Aerosol is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Xopenex HFA Aerosol. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Generic Name: Levalbuterol (lev-al-BYOO-ter-ol)
Brand Name: Xopenex

Xopenex Solution is used for:

Treating breathing problems in patients who have asthma or certain other airway diseases. It may also be used for other conditions as determined by your doctor.

Xopenex Solution is a sympathomimetic (beta agonist) bronchodilator. It works by relaxing the smooth muscle in the airway, which allows air to flow in and out of the lungs more easily.

Do NOT use Xopenex Solution if:

• you are allergic to any ingredient in Xopenex Solution or to albuterol

Contact your doctor or health care provider right away if any of these apply to you.

Before using Xopenex Solution:

Some medical conditions may interact with Xopenex Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a history of heart problems (eg, fast or irregular heartbeat, heart failure), blood vessel problems, high blood pressure, or low blood potassium levels
• if you have a history of seizures, diabetes, an overactive thyroid, kidney problems, or an adrenal gland tumor (pheochromocytoma)
• if you have ever had an unusual reaction to another sympathomimetic medicine (eg, albuterol, pseudoephedrine)
• if you are taking a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) or tricyclic antidepressant (eg, amitriptyline), or if you have taken either of these medicines within the last 14 days

Some MEDICINES MAY INTERACT with Xopenex Solution. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Diuretics (eg, furosemide, hydrochlorothiazide) because the risk of low blood potassium levels may be increased
• Catechol-O-methyltransferase (COMT) inhibitors (eg, entacapone), epinephrine, MAOIs (eg, phenelzine), short-acting sympathomimetic bronchodilators (eg, metaproterenol), stimulants (eg, amphetamine), sympathomimetics (eg, pseudoephedrine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Xopenex Solution’s side effects
• Beta-blockers (eg, propranolol) because they may decrease Xopenex Solution’s effectiveness
• Digoxin because its effectiveness may be decreased by Xopenex Solution

This may not be a complete list of all interactions that may occur. Ask your health care provider if Xopenex Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Xopenex Solution:

Use Xopenex Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Xopenex Solution. Talk to your pharmacist if you have questions about this information.
• Xopenex Solution is for inhalation only. Do not get it in your eyes. If you get Xopenex Solution in your eyes, rinse immediately with cool tap water.
• Do not open the foil pouch until you are ready to use a dose of Xopenex Solution. Remove a vial from the foil pouch. Use right away.
• Do not use Xopenex Solution if it contains particles, is cloudy or discolored, or if the bottle is cracked or damaged.
• To use Xopenex Solution, twist open the top of the vial and pour the entire contents into the nebulizer reservoir.
• Add sterile saline solution as directed by your doctor. Gently swirl the nebulizer to mix the contents.
• Connect the nebulizer reservoir to the mouthpiece or face mask. Connect the nebulizer to the compressor.
• Sit in a comfortable, upright position. Place the mouthpiece in your mouth (or put on the face mask) and turn on the nebulizer.
• Breathe as calmly, deeply, and evenly as possible until no more mist is formed in the nebulizer chamber (about 5 to 15 minutes).
• Clean the nebulizer according to the instructions. Failure to properly clean the nebulizer could lead to bacteria entering the medicine. This may lead to an infection. To avoid bacteria entering the medicine, do not save medicine in an open vial for use at a later time.
• Do not stop using Xopenex Solution without checking with your doctor.
• Do not mix Xopenex Solution with other medicines in the nebulizer unless directed otherwise by your doctor.
• If you miss a dose of Xopenex Solution and you are using it regularly, use it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Xopenex Solution.

Important safety information:

• Xopenex Solution may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Xopenex Solution with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Xopenex Solution may sometimes cause severe breathing problems right after you use a dose. If this happens, seek medical care at once.
• If your usual dose does not work well, your symptoms become worse, or you need to use it more often than normal, contact your doctor at once. This may be a sign of seriously worsening asthma. Your doctor may need to change your dose or medicine.
• Do NOT use more than the recommended dose or use more often than prescribed without checking with your doctor. The risk of severe heart problems and sometimes death may be increased with overuse of Xopenex Solution.
• Xopenex Solution may cause dry mouth or an unpleasant taste in your mouth. Rinsing your mouth with water after each dose may help relieve these effects.
• Tell your doctor or dentist that you take Xopenex Solution before you receive any medical or dental care, emergency care, or surgery.
• Check with your doctor before using any other inhaled medicines while you are using Xopenex Solution. Talk with your doctor or pharmacist about all of your asthma medicines and how to use them. Do not start, stop, or change the dose of any asthma medicine unless your doctor tell you to.
• Diabetes patients – Xopenex Solution may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• When your medicine supply begins to run low, call your doctor or pharmacy as soon as possible for a refill.
• Lab tests, including lung function, may be performed while you use Xopenex Solution. These tests may be used to monitor your condition of check for side effects. Be sure to keep all doctor and lab appointments.
• Use Xopenex Solution with caution in the ELDERLY; they may be more sensitive to its effects.
• Xopenex Solution should be used with extreme caution in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.
• Caution is advised when using Xopenex Solution in CHILDREN; they may be more sensitive to its effects, especially diarrhea or fever.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Xopenex Solution while you are pregnant. It is not known if Xopenex Solution is found in breast milk. If you are or will be breast-feeding while you use Xopenex Solution, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Xopenex Solution:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Cough; diarrhea; dizziness; headache; nervousness; sinus inflammation; sore throat; stomach upset; stuffy nose; tremor.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; fast or irregular heartbeat; fever; new or worsened trouble breathing; pounding in the chest; severe cough; severe headache or dizziness; unusual hoarseness; wheezing.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include chest pain; fast or irregular heartbeat; nausea; seizures; severe headache or dizziness; severe or persistent nervousness, trouble sleeping, or tremor; unusual fatigue.

Proper storage of Xopenex Solution:

Store Xopenex Solution between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Store vials in the protective foil pouch at all times. Use Xopenex Solution right away after it has been removed from the foil pouch. Do not use after expiration date on the container or box. Keep Xopenex Solution out of the reach of children and away from pets.

General information:

• If you have any questions about Xopenex Solution, please talk with your doctor, pharmacist, or other health care provider.
• Xopenex Solution is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Xopenex Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Generic Name: Ketoconazole Gel and Pyrithione Zinc Shampoo (KEE-toe-KON-a-zole/PIR-i-THYE-one zink)
Brand Name: Xolegel Duo

Xolegel Duo Gel is used for:

Treating and preventing itching, flaking, and scaling of the skin and scalp caused by seborrheic dermatitis and dandruff.

Xolegel Duo Gel is a convenience pack containing an antifungal gel and antiseborrheic shampoo. The antifungal works by killing the fungus causing the skin condition. The antiseborrheic works by slowing the production of skin cells, which helps to reduce flakiness.

Do NOT use Xolegel Duo Gel if:

• you are allergic to any ingredient in Xolegel Duo Gel

Contact your doctor or health care provider right away if any of these apply to you.

Before using Xolegel Duo Gel:

Some medical conditions may interact with Xolegel Duo Gel. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a condition that covers a large area of the body
• if you have a weakened immune system, liver problems, or the blood disease porphyria

Some MEDICINES MAY INTERACT with Xolegel Duo Gel. Because little, if any, of Xolegel Duo Gel is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Xolegel Duo Gel may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Xolegel Duo Gel:

Use Xolegel Duo Gel as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• FOR THE GEL: Wash your hands before and right after using Xolegel Duo Gel. Spread a thick layer of Xolegel Duo Gel onto the affected skin with the tips of your fingers. Gently rub it in. Be sure to cover the entire affected area and the healthy skin around it. Do not touch your eyes or nose while you are applying Xolegel Duo Gel.
• Wait for at least 20 minutes after you apply the gel before you apply makeup or sunscreen.
• Do not wash the area where you applied the gel for at least 3 hours after you apply it.
• FOR THE SHAMPOO: Shake well before each use. Wet hair thoroughly. Apply the shampoo and work it into a lather. Rinse thoroughly. You may repeat if desired unless your doctor tells you otherwise.
• For best results, use the shampoo at least 2 times per week or as directed by your doctor. Do not use more often than once daily.
• IF YOU MISS A DOSE OF THE GEL, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once. IF YOU MISS A DOSE OF THE SHAMPOO, use the dose when you remember. Continue to use Xolegel Duo Gel as directed by your doctor or the package labeling.

Ask your health care provider any questions you may have about how to use Xolegel Duo Gel.

Important safety information:

• Xolegel Duo Gel is for external use only. Do not get it in your eyes, nose, or mouth. If you get it in any of these areas, rinse at once with cool tap water. Do not get Xolegel Duo Gel in your vagina.
• Check with your doctor before you use Xolegel Duo Gel if your condition covers a large area of your body.
• If your symptoms do not improve with regular use or if they become worse, consult your doctor.
• Do not use Xolegel Duo Gel for other skin conditions at a later time.
• The gel in this convenience pack is flammable. Do not store or use near an open flame. Do not smoke during or right after use of Xolegel Duo Gel.
• Xolegel Duo Gel should be used with extreme caution in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Xolegel Duo Gel while you are pregnant. It is not known if Xolegel Duo Gel is found in breast milk after topical use. If you are or will be breast-feeding while you use Xolegel Duo Gel, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Xolegel Duo Gel:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Mild burning at the application site.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blisters, irritation, pain, redness, or severe burning at the application site.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Xolegel Duo Gel is harmful if swallowed.

Proper storage of Xolegel Duo Gel:

Store Xolegel Duo Gel at room temperature, at 77 degrees F (25 degrees C). Brief storage between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do NOT store near an open flame. Keep Xolegel Duo Gel out of the reach of children and away from pets.

General information:

• If you have any questions about Xolegel Duo Gel, please talk with your doctor, pharmacist, or other health care provider.
• Xolegel Duo Gel is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Xolegel Duo Gel. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Generic Name: Ketoconazole/Hydrocortisone (KEE-toe-KON-a-zole/HYE-droe-KOR-ti-sone)
Brand Name: Xolegel CorePak

Xolegel CorePak Gel is used for:

Treating a skin condition called seborrheic dermatitis. It may also help to reduce itching, redness, and swelling.

Xolegel CorePak Gel kit contains an antifungal medicine and a topical corticosteroid. The antifungal works by killing the fungus causing the skin condition. The corticosteroid works by reducing skin inflammation, which helps relieve redness, swelling, itching, and irritation.

Do NOT use Xolegel CorePak Gel if:

• you are allergic to any ingredient in Xolegel CorePak Gel

Contact your doctor or health care provider right away if this applies to you.

Before using Xolegel CorePak Gel:

Some medical conditions may interact with Xolegel CorePak Gel. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a weakened immune system, liver problems, or the blood disease porphyria
• if you have a skin infection, measles, thinning of the skin, tuberculosis (TB), chickenpox, shingles, a positive TB skin test, or have recently had a vaccination

Some MEDICINES MAY INTERACT with Xolegel CorePak Gel. Because little, if any, of Xolegel CorePak Gel is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Xolegel CorePak Gel may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Xolegel CorePak Gel:

Use Xolegel CorePak Gel as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Xolegel CorePak Gel. Talk to your pharmacist if you have questions about this information.
• Wash your hands before and immediately after using Xolegel CorePak Gel.
• To use the antifungal: Spread a thin layer of the medicine onto the affected area with the tips of your fingers. Gently rub it in. Be sure to cover the entire affected area and the healthy skin around it.
• Do not touch your eyes or nose while you are applying Xolegel CorePak Gel.
• Wait for at least 20 minutes after you apply Xolegel CorePak Gel before you apply makeup or sunscreen.
• Do not wash the area where you applied Xolegel CorePak Gel for at least 3 hours after you apply it.
• To use the topical corticosteroid: Apply a small amount of medicine to the affected area. Gently rub it in until it is evenly distributed.
• Do not bandage or wrap the affected area unless directed otherwise by your doctor.
• If you miss a dose of Xolegel CorePak Gel, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Xolegel CorePak Gel.

Important safety information:

• Xolegel CorePak Gel is for external use only. Do not get it in your eyes, nose, or mouth. If you get it in your eyes, rinse at once with cool tap water. Do not get Xolegel CorePak Gel in your vagina.
• Do not use Xolegel CorePak Gel for other skin conditions at a later time.
• Xolegel CorePak Gel is flammable. Do not store or use near an open flame. Do not smoke during or right after use of Xolegel CorePak Gel.
• Check with your doctor before receiving vaccinations while you are using Xolegel CorePak Gel.
• Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Xolegel CorePak Gel, especially if the child is using a large amount of it or using it for a long period of time.
• Xolegel CorePak Gel should be used with extreme caution in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Xolegel CorePak Gel while you are pregnant. It is not known if Xolegel CorePak Gel is found in breast milk after topical use. If you are or will be breast-feeding while you use Xolegel CorePak Gel, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Xolegel CorePak Gel:

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Mild skin irritation or dryness; mild, temporary burning or stinging at the application site.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); infection; new or worsening irritation, pain, redness, blistering, or severe burning at the application site; skin thinning or discoloration.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.

Proper storage of Xolegel CorePak Gel:

Store Xolegel CorePak Gel at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do NOT store near an open flame. Keep Xolegel CorePak Gel out of the reach of children and away from pets.

General information:

• If you have any questions about Xolegel CorePak Gel, please talk with your doctor, pharmacist, or other health care provider.
• Xolegel CorePak Gel is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Xolegel CorePak Gel. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Generic Name: Ketoconazole (KEE-toe-KON-a-zole)
Brand Name: Xolegel

Xolegel Gel is used for:

Treating a skin condition called seborrheic dermatitis.

Xolegel Gel is an antifungal agent. It works by killing the fungus causing the skin condition.

Do NOT use Xolegel Gel if:

• you are allergic to any ingredient in Xolegel Gel

Contact your doctor or health care provider right away if any of these apply to you.

Before using Xolegel Gel:

Some medical conditions may interact with Xolegel Gel. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a weakened immune system, liver problems, or the blood disease porphyria

Some MEDICINES MAY INTERACT with Xolegel Gel. Because little, if any, of Xolegel Gel is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Xolegel Gel may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Xolegel Gel:

Use Xolegel Gel as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Xolegel Gel. Talk to your pharmacist if you have questions about this information.
• Wash your hands before and immediately after using Xolegel Gel.
• Spread a thin layer of Xolegel Gel onto the affected area with the tips of your fingers. Gently rub it in. Be sure to cover the entire affected area and the healthy skin around it.
• Do not touch your eyes or nose while you are applying Xolegel Gel.
• Wait for at least 20 minutes after you apply Xolegel Gel before you apply makeup or sunscreen.
• Do not wash the area where you applied Xolegel Gel for at least 3 hours after you apply it.
• If you miss a dose of Xolegel Gel, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Xolegel Gel.

Important safety information:

• Xolegel Gel is for external use only. Do not get it in your eyes, nose, or mouth. If you get it in your eyes, rinse at once with cool tap water. Do not get Xolegel Gel in your vagina.
• Do not use Xolegel Gel for other skin conditions at a later time.
• Xolegel Gel is flammable. Do not store or use near an open flame. Do not smoke during or right after use of Xolegel Gel.
• Xolegel Gel should be used with extreme caution in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Xolegel Gel while you are pregnant. It is not known if Xolegel Gel is found in breast milk after topical use. If you are or will be breast-feeding while you use Xolegel Gel, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Xolegel Gel:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Mild burning at the application site.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blisters, irritation, pain, redness, or severe burning at the application site.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.

Proper storage of Xolegel Gel:

Store Xolegel Gel at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do NOT store near an open flame. Keep Xolegel Gel out of the reach of children and away from pets.

General information:

• If you have any questions about Xolegel Gel, please talk with your doctor, pharmacist, or other health care provider.
• Xolegel Gel is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Xolegel Gel. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Generic Name: Chlorpheniramine/Pseudoephedrine/Methscopolamine (KLOR-fen-IR-a-meen/SOO-doe-e-FED-rin/METH-skoe-POL-a-meen)
Brand Name: Examples include Dallergy PSE and Relcof PSE

Xiral SR Sustained-Release Tablets are used for:

Relieving congestion, sneezing, runny nose, and itchy, watery eyes due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Xiral SR Sustained-Release Tablets are an antihistamine, decongestant, and anticholinergic combination. It works by blocking histamine, a substance in the body that causes sneezing, runny nose, and watery eyes. It also relieves nasal congestion by shrinking the nasal mucous membranes, which promotes nasal drainage, and dries the chest by decreasing lung secretions.

Do NOT use Xiral SR Sustained-Release Tablets if:

• you are allergic to any ingredient in Xiral SR Sustained-Release Tablets
• you are pregnant or breast-feeding
• you take sodium oxybate (GHB) or you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days
• you have severe heart blood vessel disease, severe high blood pressure, narrow-angle glaucoma, severe bleeding, severe irritation of the esophagus or other serious problems with the esophagus (eg, esophageal achalasia), peptic ulcer, a blockage of your stomach or bowel, bowel motility problems, severe bowel inflammation (eg, ulcerative colitis), certain muscle problems (eg, myasthenia gravis), or uncontrolled bleeding
• you are unable to urinate or are having an asthma attack

Contact your doctor or health care provider right away if any of these apply to you.

Before using Xiral SR Sustained-Release Tablets:

Some medical conditions may interact with Xiral SR Sustained-Release Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a history of diabetes, an enlarged prostate, bladder or kidney problems, high blood pressure, diarrhea, asthma, nerve problems, heart problems, blood clots, a hiatal hernia, an adrenal gland tumor, glaucoma, breathing problems during sleep, seizures, myasthenia gravis (muscle weakness), or an overactive thyroid

Some MEDICINES MAY INTERACT with Xiral SR Sustained-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Alpha-blockers (eg, guanethidine, methyldopa, prazosin), beta-blockers (eg, atenolol), diuretics (eg, furosemide, hydrochlorothiazide), furazolidone, or MAOIs (eg, phenelzine) because the risk of high or low blood pressure may be increased
• Alkalizers (eg, calcium or magnesium antacids), anticholinergics (eg, atropine, benztropine, dicyclomine), carbonic anhydrase inhibitors (eg, acetazolamide), ergotamine, sodium bicarbonate, or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Xiral SR Sustained-Release Tablets’s side effects
• Bromocriptine, catechol-O-methyltransferase (COMT) inhibitors (eg, entacapone), certain stimulants (eg, doxapram, pseudoephedrine), cocaine, digoxin, droxidopa, potassium chloride, or sodium oxybate (GHB) because the risk of their side effects may be increased by Xiral SR Sustained-Release Tablets
• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Xiral SR Sustained-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Xiral SR Sustained-Release Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Xiral SR Sustained-Release Tablets:

Use Xiral SR Sustained-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Xiral SR Sustained-Release Tablets by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• Do not take Xiral SR Sustained-Release Tablets at the same time as an antacid, certain medicines for diarrhea (eg, attapulgite, bismuth, kaolin, pectin), or ketoconazole. Take these medicines 2 or 3 hours before or after you take Xiral SR Sustained-Release Tablets.
• Swallow Xiral SR Sustained-Release Tablets whole. Do not break, crush, or chew before swallowing. Some brands of Xiral SR Sustained-Release Tablets may be broken in half before taking. If you have difficulty swallowing the whole tablet, ask your pharmacist if your brand of medicine may be broken in half.
• If you miss a dose of Xiral SR Sustained-Release Tablets and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Xiral SR Sustained-Release Tablets.

Important safety information:

• Xiral SR Sustained-Release Tablets may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Xiral SR Sustained-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• If your symptoms do not get better within 7 days or if they get worse or you develop a high fever or persistent headache, check with your doctor.
• Xiral SR Sustained-Release Tablets may cause dry mouth. To relieve dry mouth, suck on sugarless hard candy or ice chips, chew sugarless gum, drink water, or use a saliva substitute.
• Xiral SR Sustained-Release Tablets may make your eyes more sensitive to sunlight. It may help to wear sunglasses.
• Xiral SR Sustained-Release Tablets may reduce sweating. Do not become overheated in hot weather or while you are being active; heatstroke may occur.
• Do not take diet or appetite control medicines while you are taking Xiral SR Sustained-Release Tablets without checking with your doctor.
• Xiral SR Sustained-Release Tablets has pseudoephedrine in it. Before you start any new medicine, check the label to see if it has pseudoephedrine in it too. If it does or if you are not sure, check with your doctor or pharmacist.
• If you have trouble sleeping, ask your doctor or pharmacist about the best time of the day to take Xiral SR Sustained-Release Tablets.
• Xiral SR Sustained-Release Tablets may interfere with certain lab tests. Be sure your doctor and lab personnel know that you are taking Xiral SR Sustained-Release Tablets.
• Tell your doctor or dentist that you take Xiral SR Sustained-Release Tablets before you receive any medical or dental care, emergency care, or surgery.
• Diabetes patients – Xiral SR Sustained-Release Tablets may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Use Xiral SR Sustained-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects.
• Caution is advised when using Xiral SR Sustained-Release Tablets in CHILDREN; they may be more sensitive to its effects.
• PREGNANCY and BREAST-FEEDING: It is not known if Xiral SR Sustained-Release Tablets can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Xiral SR Sustained-Release Tablets while you are pregnant. Xiral SR Sustained-Release Tablets are found in breast milk. Do not breast-feed while taking Xiral SR Sustained-Release Tablets.

Possible side effects of Xiral SR Sustained-Release Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; dry mouth, nose, or throat; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; mental or mood changes; seizures; severe dizziness, lightheadedness, or headache; tremor; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include deep sleep or loss of consciousness; hot or cool skin; irregular heartbeat; irritability, anxiety, or panic; large pupils; numbness or tingling in the arms or legs; seizures; slowed or shallow breathing.

Proper storage of Xiral SR Sustained-Release Tablets:

Store Xiral SR Sustained-Release Tablets in a tightly closed container between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Xiral SR Sustained-Release Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Xiral SR Sustained-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
• Xiral SR Sustained-Release Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Xiral SR Sustained-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Generic Name: Balsam Peru/Castor Oil/Trypsin (BAL-sum pe-ROO/KAS-tor oil/TRIP-sin)
Brand Name: Xenaderm

Xenaderm Ointment is used for:

Treating skin wounds and promoting wound healing.

Xenaderm Ointment is a wound agent. It works by stimulating blood vessel activity and removal of unhealthy tissue. The castor oil works as a lubricant to protect the tissue.

Do NOT use Xenaderm Ointment if:

• you are allergic to any ingredient in Xenaderm Ointment

Contact your doctor or health care provider right away if any of these apply to you.

Before using Xenaderm Ointment:

Some medical conditions may interact with Xenaderm Ointment. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a wound that contains a certain type of fresh blood clot

Some MEDICINES MAY INTERACT with Xenaderm Ointment. Because little, if any, of Xenaderm Ointment is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Xenaderm Ointment may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Xenaderm Ointment:

Use Xenaderm Ointment as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Clean the wound before applying Xenaderm Ointment.
• Apply a thin film of Xenaderm Ointment to the affected area. The wound may be left unbandaged or an appropriate dressing may be applied as directed by your doctor.
• To remove, wash gently with water.
• Wash your hands immediately after using Xenaderm Ointment, unless your hands are part of the treated area.
• Xenaderm Ointment is for external use only. Avoid getting Xenaderm Ointment in the eyes, nostrils, or mouth.
• If you miss a dose of Xenaderm Ointment, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Xenaderm Ointment.

Important safety information:

• Xenaderm Ointment may cause harm if it is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away.
• It may take several days for Xenaderm Ointment to work. Do not stop using Xenaderm Ointment without checking with your doctor.
• If your wound does not improve or becomes worse, check with your doctor.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Xenaderm Ointment while you are pregnant. It is not known if Xenaderm Ointment is found in breast milk. If you are or will be breast-feeding while you use Xenaderm Ointment, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Xenaderm Ointment:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Temporary stinging.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Xenaderm Ointment may be harmful if swallowed.

Proper storage of Xenaderm Ointment:

Store Xenaderm Ointment at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Do not store above 120 degrees F (49 degrees C). Store away from heat and direct sunlight. Do not store in the bathroom. Do not puncture, break, or burn the canister even if it appears to be empty. Keep Xenaderm Ointment out of the reach of children and away from pets.

General information:

• If you have any questions about Xenaderm Ointment, please talk with your doctor, pharmacist, or other health care provider.
• Xenaderm Ointment is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Xenaderm Ointment. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Generic Name: Alprazolam (al-PRAY-zoe-lam)
Brand Name: Xanax XR

Xanax XR Extended-Release Tablets are used for:

Treating anxiety and panic disorder. It may also be used to treat other conditions as determined by your doctor.

Xanax XR Extended-Release Tablets are a benzodiazepine. It works by slowing down the movement of chemicals in the brain. This results in a reduction in nervous tension (anxiety).

Do NOT use Xanax XR Extended-Release Tablets if:

• you are allergic to any ingredient in Xanax XR Extended-Release Tablets or other benzodiazepines (eg, diazepam)
• you have acute narrow-angle glaucoma, severe liver disease, or a mental state where contact with reality is lost (psychosis)
• you are taking an azole antifungal (eg, itraconazole, ketoconazole), delavirdine, or sodium oxybate (GHB)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Xanax XR Extended-Release Tablets:

Some medical conditions may interact with Xanax XR Extended-Release Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, plan to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines or other substances
• if you have glaucoma or a predisposition for glaucoma, liver problems, lung problems or chronic obstructive pulmonary disease (COPD), muscle problems, depression, suicidal tendencies, a blood disorder known as porphyria, or a history of substance abuse or dependence
• if you consume alcoholic beverages or smoke cigarettes

Some MEDICINES MAY INTERACT with Xanax XR Extended-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Rifampin or St. John’s wort because the effectiveness of Xanax XR Extended-Release Tablets may be decreased
• Azole antifungals (eg, itraconazole, ketoconazole), cimetidine, clozapine, delavirdine, fluvoxamine, HIV protease inhibitors (eg, ritonavir), fluoxetine, macrolides and ketolides (eg, erythromycin, azithromycin), nefazodone, omeprazole, propoxyphene, sodium oxybate (GHB), or valproic acid because side effects such as increased sedation or heart problems may occur
• Clozapine, hydantoins (eg, phenytoin), or valproic acid because the actions and side effects of these medicines may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Xanax XR Extended-Release Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Xanax XR Extended-Release Tablets:

Use Xanax XR Extended-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Xanax XR Extended-Release Tablets may be taken with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• Swallow whole. Do not break, crush, or chew before swallowing.
• Avoid eating grapefruit or drinking grapefruit juice while you are being treated with Xanax XR Extended-Release Tablets.
• If you miss a dose of Xanax XR Extended-Release Tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Xanax XR Extended-Release Tablets.

Important safety information:

• Xanax XR Extended-Release Tablets may cause drowsiness, dizziness, lightheadedness, or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Xanax XR Extended-Release Tablets. Using Xanax XR Extended-Release Tablets alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.
• Avoid drinking alcohol or taking other medications that cause drowsiness (eg, sedatives, tranquilizers) while taking Xanax XR Extended-Release Tablets. Xanax XR Extended-Release Tablets will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.
• Do not smoke while using Xanax XR Extended-Release Tablets. Cigarette smoking decreases blood levels of Xanax XR Extended-Release Tablets. Tell your doctor if you smoke or if you have recently stopped smoking.
• Use Xanax XR Extended-Release Tablets with caution in the ELDERLY because they may be more sensitive to the effects of Xanax XR Extended-Release Tablets, especially the drowsiness effect.
• Xanax XR Extended-Release Tablets are not recommended for use in CHILDREN; safety and effectiveness have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Xanax XR Extended-Release Tablets has been shown to cause harm to the human fetus. If you plan on becoming pregnant, discuss with your doctor the benefits and risks of using Xanax XR Extended-Release Tablets during pregnancy. Xanax XR Extended-Release Tablets are excreted in breast milk. Do not breast-feed while taking Xanax XR Extended-Release Tablets.

When used for long periods of time or at high doses, Xanax XR Extended-Release Tablets may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Xanax XR Extended-Release Tablets stops working well. Do not take more than prescribed.

Xanax XR Extended-Release Tablets may be habit-forming and lead to DEPENDENCE if used in high doses or for a long period of time. If you are on long-term or high dosage therapy, you may have WITHDRAWAL symptoms (eg, convulsions, tremor, stomach and muscle cramps, vomiting, sweating) if you suddenly stop taking Xanax XR Extended-Release Tablets. Do not stop therapy abruptly or change dosage without asking your pharmacist or doctor. Discuss overuse with your doctor or pharmacist.

Possible side effects of Xanax XR Extended-Release Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Changes in appetite; changes in sexual desire; constipation; dizziness; drowsiness; dry mouth; increased saliva production; lightheadedness; tiredness; trouble concentrating; unsteadiness; weight changes.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; decreased urination; fainting; hallucinations; loss of coordination; memory problems; menstrual changes; muscle twitching; new or worsening mental or mood problems (eg, depression, irritability, anxiety); overstimulation; red, swollen blistered, or peeling skin; seizures; severe dizziness; severe or persistent trouble sleeping; suicidal thoughts or actions; trouble speaking (eg, stammering, stuttering); yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include loss of consciousness; loss of coordination; severe confusion; severe drowsiness or deep sleep; slow reflexes.

Proper storage of Xanax XR Extended-Release Tablets:

Store Xanax XR Extended-Release Tablets at room temperature between 59 and 86 degrees F (15 and 30 degrees C) in a tightly-closed container, away from heat, moisture, and light. Do not store in the bathroom. Keep Xanax XR Extended-Release Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Xanax XR Extended-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
• Xanax XR Extended-Release Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Xanax XR Extended-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Generic Name: Coal Tar/Salicylic Acid (kohl tar/sal-ih-SILL-ik AS-id)
Brand Name: Examples include Tarsum and X-Seb T Plus

X-Seb T Plus Shampoo is used for:

Relieving itching, flaking, irritation, redness, and scaling due to dandruff, seborrheic dermatitis, and psoriasis of the scalp. It may also be used for other conditions as determined by your doctor.

X-Seb T Plus Shampoo is a topical coal tar and salicylate combination. It works by causing the skin to swell, soften, and then slough or peel in areas where it is applied.

Do NOT use X-Seb T Plus Shampoo if:

• you are allergic to any ingredient in X-Seb T Plus Shampoo
• you are using prescription medicine or other treatments (eg, ultraviolet radiation therapy) to treat your condition, unless instructed by your doctor

Contact your doctor or health care provider right away if any of these apply to you.

Before using X-Seb T Plus Shampoo:

Some medical conditions may interact with X-Seb T Plus Shampoo. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to aspirin or a nonsteroidal anti-inflammatory drug (NSAID) (eg, ibuprofen, naproxen, celecoxib)
• if you have liver or kidney problems, a skin infection, skin irritation, eczema, diabetes, or poor blood circulation

Some MEDICINES MAY INTERACT with X-Seb T Plus Shampoo. Because little, if any, of X-Seb T Plus Shampoo is absorbed into the blood, the risk of it interacting with another medicine is low.

This may not be a complete list of all interactions that may occur. Ask your health care provider if X-Seb T Plus Shampoo may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use X-Seb T Plus Shampoo:

Use X-Seb T Plus Shampoo as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Shake well before each use.
• Wet hair and shampoo for a full 5 minutes. Rinse and repeat. Be sure to wash your hands after each use.
• If you miss a dose of X-Seb T Plus Shampoo, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use X-Seb T Plus Shampoo.

Important safety information:

• X-Seb T Plus Shampoo is for external use only. Avoid getting X-Seb T Plus Shampoo in your eyes, nose, or mouth, or on the genitals. If contact with your eyes occurs, flush with water for 15 minutes. Do not inhale the vapors of X-Seb T Plus Shampoo.
• Overuse of topical products may worsen your condition.
• Do not use X-Seb T Plus Shampoo longer or more often than recommended by your doctor or on the package label.
• Check with your doctor before use if you have a condition that covers a large area of the body.
• Be sure to apply X-Seb T Plus Shampoo only to the affected area and not to normal healthy skin.
• Do not use X-Seb T Plus Shampoo on skin that is irritated, infected, or reddened.
• Do not use X-Seb T Plus Shampoo on open skin wounds, moles, birthmarks, genital warts, warts on the face, or warts growing hair.
• Do not use any other medicines or drying products on your skin unless your doctor instructs you otherwise.
• X-Seb T Plus Shampoo contains a salicylate, which has been linked to Reye syndrome. Do not use X-Seb T Plus Shampoo on children or teenagers during or after chickenpox, flu, or other viral infections without checking with your doctor or pharmacist.
• X-Seb T Plus Shampoo may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to X-Seb T Plus Shampoo. Use a sunscreen or protective clothing if you must be outside for a prolonged period.
• Use X-Seb T Plus Shampoo with extreme caution in CHILDREN younger than 2 years of age. Safety and effectiveness in this age group have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using X-Seb T Plus Shampoo during pregnancy. It is unknown if X-Seb T Plus Shampoo is excreted in breast milk. Do not breast-feed while you are using X-Seb T Plus Shampoo.

Possible side effects of X-Seb T Plus Shampoo:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dry, peeling, red, or scaling skin.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); severe irritation.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org ), or emergency room immediately. Symptoms may include agitation; diarrhea; dizziness; loss of appetite; loss of hearing; mental disturbances; nausea; rapid or difficult breathing; ringing in the ears; seizures; sluggishness; vomiting; yellowing of the skin or eyes.

Proper storage of X-Seb T Plus Shampoo:

Store X-Seb T Plus Shampoo at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not freeze. Do not store in the bathroom. Keep X-Seb T Plus Shampoo out of the reach of children and away from pets.

General information:

• If you have any questions about X-Seb T Plus Shampoo, please talk with your doctor, pharmacist, or other health care provider.
• X-Seb T Plus Shampoo is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about X-Seb T Plus Shampoo. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.