Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

MONUROL is usually given in only one dose. Do not take more than a single dose unless your doctor tells you to.

You may take MONUROL with or without food.

MONUROL is a powder medicine that must be mixed with water before using it. Do not take the dry powder without adding water.

Dissolve the powder in 3 to 4 ounces (1/2 cup) of cold water. Stir this mixture and drink all of it right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

Do not mix MONUROL oral powder with hot water.

It may take 2 or 3 days before your symptoms improve.

Call your doctor if your symptoms do not improve within 3 days after treatment, or if you have a fever or any other new symptoms.

To be sure MONUROL is the right antibiotic for the type of infection you have, your urine may need to be tested before and after you take this medicine.

Store at room temperature away from moisture and heat. Keep the powder in its original package until you are ready to mix your dose.

Seek emergency medical attention or call the Poison Help line.

Since MONUROL is used as a single dose, an overdose is unlikely to occur.

Since MONUROL is used as a single dose, it does not have a daily dosing schedule.

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.

Call your doctor at once if you have:

• diarrhea that is watery or bloody; or
• new or worsening bladder symptoms (burning, painful urination).

Common side effects may include:

• nausea, upset stomach, mild diarrhea;
• headache, dizziness;
• weakness;
• sore throat, runny nose;
• back pain; or
• vaginal itching or discharge.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

You should not use MONUROL if you are allergic to it.

FDA pregnancy category B. MONUROL is not expected to harm an unborn baby. Tell your doctor if you are pregnant.

It is not known whether MONUROL passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

MONUROL should not be given to a child younger than 12 years old.

Do not share this medicine with another person, even if they have the same symptoms you have.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop taking MONUROL and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Other drugs may interact with MONUROL, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

For children 6 months to 3 years of age, the usual recommended dose is based on body weight, 0.05 mg per kilogram of weight twice daily, in the morning and evening.

For children over 3 years of age, the usual recommended dose is 1 mg twice daily, in the morning and evening.

To reduce side effects, your child's doctor may suggest you start with a lower dose and increase to the recommended dose after 5 days.

Many things can affect the dose of medication that a child needs, such as body weight, other medications, or medications. If you doctor has recommended a dose different from the one listed here, do not change the way that you are giving the medication to your child without consulting your doctor.

Use an oral syringe to measure each dose of the liquid, as it gives a more accurate measurement than household teaspoons.

ZADITEN tablets and liquid are both to be swallowed. It may be taken with or without food.

ZADITEN does not relieve symptoms of an asthma or allergic attack. It must be taken regularly for it to be effective.

It is important to use this medication exactly as prescribed by your doctor. If you miss giving your child a dose, give it as soon as possible and continue with the regular dosing schedule. If it is almost time for your child's next dose, skip the missed dose and continue with the regular dosing schedule. Do not give your child a double dose to make up for the missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store both forms of ZADITEN at room temperature, protect from moisture, and keep out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people using this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if your child experiences these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• abdominal pain
• drowsiness
• dry mouth
• headache
• increased appetite
• irritability
• nausea
• nervousness
• sleep disturbances (e.g., trouble sleeping)
• slight dizziness
• weight gain

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• flu-like symptoms (e.g., sudden lack of energy, fever, cough, sore throat)
• nosebleeds
• puffy eyelid(s)
• respiratory infections
• skin rashes and itching

Stop using the medication and seek immediate medical attention if any of the following occur:

• signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are using this medication.

Your doctor may have suggested this medication for conditions other than those listed in this drug information. As well, some forms of this medication may not be used for all of the conditions discussed here. If you have not discussed this with your doctor or are not sure why you are using this medication, speak to your doctor. Do not stop giving this medication to your child without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as your child. It can be harmful for people to use this medication if their doctor has not prescribed it.

This medication should not be given to anyone who:

• is allergic to ZADITEN or any ingredients of this medication
• is sensitive to benzoate compounds

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Diabetes: If you have diabetes, you should be aware that the syrup form of this medication contains 4 g of carbohydrates per 5 mL of syrup. There have also been rare reports of decreased blood cell counts in people taking antidiabetes medications and ZADITEN at the same time. Talk to your doctor if you have any concerns.

Drowsiness/reduced alertness: This medication may cause drowsiness. Parents and guardians should be aware that children may experience drowsiness in the early stages of therapy. They should not perform potentially hazardous tasks until you have determined how this medication affects them.

Other asthma medications: Medications used to treat and prevent asthma (e.g., b2-agonists such as salbutamol; sodium cromoglycate; corticosteroids such as beclomethasone, budesonide, and fluticasone) already in use should not be reduced immediately when treatment with ZADITEN is started. Follow your doctor's instructions closely.

Seizure: ZADITEN may increase the risk of seizures, particularly if your child has a history of seizures. If you or your child have seizures or a history of seizures, discuss with your doctor how this medication may affect this medical condition, how this medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Pregnancy and breast-feeding: ZADITEN should not be used by anyone who is pregnant or breast-feeding.

There may be an interaction between ZADITEN and any of the following:

• antidiabetes medications (e.g., glyburide, metformin)
• medications that cause drowsiness (e.g. sleeping pills, antihistamines, alcohol)

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

For children 6 months to 3 years of age, the usual recommended dose is based on body weight, 0.05 mg per kilogram of weight twice daily, in the morning and evening.

For children over 3 years of age, the usual recommended dose is 1 mg twice daily, in the morning and evening.

To reduce side effects, your child's doctor may suggest you start with a lower dose and increase to the recommended dose after 5 days.

Many things can affect the dose of medication that a child needs, such as body weight, other medications, or medications. If you doctor has recommended a dose different from the one listed here, do not change the way that you are giving the medication to your child without consulting your doctor.

Use an oral syringe to measure each dose of the liquid, as it gives a more accurate measurement than household teaspoons.

ZADITEN tablets and liquid are both to be swallowed. It may be taken with or without food.

ZADITEN does not relieve symptoms of an asthma or allergic attack. It must be taken regularly for it to be effective.

It is important to use this medication exactly as prescribed by your doctor. If you miss giving your child a dose, give it as soon as possible and continue with the regular dosing schedule. If it is almost time for your child's next dose, skip the missed dose and continue with the regular dosing schedule. Do not give your child a double dose to make up for the missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store both forms of ZADITEN at room temperature, protect from moisture, and keep out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people using this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if your child experiences these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• abdominal pain
• drowsiness
• dry mouth
• headache
• increased appetite
• irritability
• nausea
• nervousness
• sleep disturbances (e.g., trouble sleeping)
• slight dizziness
• weight gain

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• flu-like symptoms (e.g., sudden lack of energy, fever, cough, sore throat)
• nosebleeds
• puffy eyelid(s)
• respiratory infections
• skin rashes and itching

Stop using the medication and seek immediate medical attention if any of the following occur:

• signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are using this medication.

Your doctor may have suggested this medication for conditions other than those listed in this drug information. As well, some forms of this medication may not be used for all of the conditions discussed here. If you have not discussed this with your doctor or are not sure why you are using this medication, speak to your doctor. Do not stop giving this medication to your child without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as your child. It can be harmful for people to use this medication if their doctor has not prescribed it.

This medication should not be given to anyone who:

• is allergic to ZADITEN or any ingredients of this medication
• is sensitive to benzoate compounds

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Diabetes: If you have diabetes, you should be aware that the syrup form of this medication contains 4 g of carbohydrates per 5 mL of syrup. There have also been rare reports of decreased blood cell counts in people taking antidiabetes medications and ZADITEN at the same time. Talk to your doctor if you have any concerns.

Drowsiness/reduced alertness: This medication may cause drowsiness. Parents and guardians should be aware that children may experience drowsiness in the early stages of therapy. They should not perform potentially hazardous tasks until you have determined how this medication affects them.

Other asthma medications: Medications used to treat and prevent asthma (e.g., b2-agonists such as salbutamol; sodium cromoglycate; corticosteroids such as beclomethasone, budesonide, and fluticasone) already in use should not be reduced immediately when treatment with ZADITEN is started. Follow your doctor's instructions closely.

Seizure: ZADITEN may increase the risk of seizures, particularly if your child has a history of seizures. If you or your child have seizures or a history of seizures, discuss with your doctor how this medication may affect this medical condition, how this medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Pregnancy and breast-feeding: ZADITEN should not be used by anyone who is pregnant or breast-feeding.

There may be an interaction between ZADITEN and any of the following:

• antidiabetes medications (e.g., glyburide, metformin)
• medications that cause drowsiness (e.g. sleeping pills, antihistamines, alcohol)

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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proper use info...

Do not use this medicine while wearing contact lenses. EMADINE  may contain a preservative that can discolor soft contact lenses. Wait at least 10 minutes after using this medicine before putting in your contact lenses.

Wash your hands before using the eye drops.

To apply the eye drops:

• Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye with the tip down. Look up and away from the dropper and squeeze out a drop.
• Close your eyes for 2 or 3 minutes with your head tipped down, without blinking or squinting. Gently press your finger to the inside corner of the eye for about 1 minute, to keep the liquid from draining into your tear duct.
• Use only the number of drops your doctor has prescribed.

Do not touch the tip of the eye dropper or place it directly on your eye. A contaminated dropper can infect your eye, which could lead to serious vision problems.

Do not use the eye drops if the liquid has changed colors or has particles in it. Call your pharmacist for new medicine.

Store at room temperature away from moisture and heat. Do not freeze. Keep the bottle tightly closed when not in use.

An overdose of EMADINE  is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line if anyone has accidentally swallowed the medication.

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

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.

Common side effects may include:

• headache;
• mild burning or stinging after using the eye drops;
• blurred vision, dry eyes; or
• strange dreams.

You should not use EMADINE if you are allergic to it.

To make sure EMADINE is safe for you, tell your doctor if you have:

• an infection in your eye (unless you are also using medicine to treat it).

FDA pregnancy category B. EMADINE is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether EMADINE passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

EMADINE is not approved for use by children younger than 3 years of age.

Do not wear contact lenses while using this medicine if your eyes are red.

Do not use other eye medications unless your doctor tells you to.

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