Nalex A 12

Nalex A 12 is part of the drug classes:

• Substituted alkylamines

• Adrenergic and dopaminergic agents

• Sympathomimetics

• Sympathomimetics excl. antiglaucoma preparations

• Sympathomimetics used as decongestants

• Sympathomimetics, combinations excl. corticosteroids

• Sympathomimetics, plain

• Antihistamines for topical use

• Substituted ethylene diamines

Do not use this medicine if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

You should not use this medicine if you are allergic to chlorpheniramine, phenylephrine, pyrilamine, or to other decongestants, or if you have:

• severe coronary artery disease;

• diabetes;

• overactive thyroid; or

• asthma, pneumonia, or other breathing problems.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:

• heart disease or high blood pressure;

• blood circulation problems;

• glaucoma;

• an ulcer or obstruction in the stomach;

• enlarged prostate;

• bladder obstruction or other urination problems; or

• a history of seizures.

It is not known whether chlorpheniramine, phenylephrine, and pyrilamine will harm an unborn baby. Ask a doctor before using this medicine if you are pregnant.

Chlorpheniramine, phenylephrine, and pyrilamine can pass into breast milk and may cause side effects in the nursing baby. Antihistamines can also slow breast milk production. You should not breast-feed while using this medicine.

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Cough or cold medicine is usually taken only for a short time until your symptoms clear up.

Do not give this medication to a child younger than 6 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

You should not use antihistamine medication to make a child sleepy.

Do not crush, chew, or break an extended-release tablet. Swallow it whole.

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Shake the oral suspension (liquid) well just before you measure a dose.

Store at room temperature away from moisture, heat, and light. Do not allow liquid medicine to freeze.

Call your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

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

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

Stop using this medicine and call your doctor at once if you have:

• confusion, hallucinations;

• feeling nervous or irritable;

• trouble sleeping;

• little or no urination;

• a seizure (convulsions);

• numbness or tingly feeling;

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

• pounding heartbeats or fluttering in your chest; or

• increased blood pressure--severe headache, blurred vision, pounding in your neck or ears, anxiety, nosebleed.

Side effects may be more likely in older adults.

Common side effects may include:

• nausea, constipation, loss of appetite;

• rash or itching;

• increased sweating;

• dry mouth, nose, or throat;

• blurred vision;

• headache, dizziness; or

• feeling restless or excited (especially in children).

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

Applies to chlorpheniramine / phenylephrine / pyrilamine: oral liquid, oral suspension, oral suspension extended release, oral tablet, oral tablet extended release

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

Stop using this medicine and call your doctor at once if you have:

• confusion, hallucinations;

• feeling nervous or irritable;

• trouble sleeping;

• little or no urination;

• a seizure (convulsions);

• numbness or tingly feeling;

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

• pounding heartbeats or fluttering in your chest; or

• increased blood pressure--severe headache, blurred vision, pounding in your neck or ears, anxiety, nosebleed.

Side effects may be more likely in older adults.

Common side effects may include:

• nausea, constipation, loss of appetite;

• rash or itching;

• increased sweating;

• dry mouth, nose, or throat;

• blurred vision;

• headache, dizziness; or

• feeling restless or excited (especially in children).

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