PediaCare Children's Multi-Symptom Cold

Dextromethorphan is a medicine that helps stop coughing. It works on the signals in the brain that cause the cough reflex.

Phenylephrine is a medicine that relieves stuffiness in the nose by shrinking the blood vessels in the nasal passages. When blood vessels are swollen, it can lead to nasal congestion (a stuffy nose).

PediaCare Children's Multi-Symptom Cold is a combination medicine used to relieve cough, stuffy nose, and sinus congestion caused by allergies, the common cold, or the flu.

PediaCare Children's Multi-Symptom Cold will not help with a cough caused by smoking, asthma, or emphysema.

PediaCare Children's Multi-Symptom Cold may also be used for other reasons not mentioned in this medication guide.

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. This medicine is usually taken only for a short time until your symptoms clear up.

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.

Do not give this medication to a child younger than 4 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.

Measure liquid medicine with a special dose measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose measuring device, ask your pharmacist for one.

If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken this medicine within the past few days.

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

Do not use PediaCare Children's Multi-Symptom Cold if you have taken an MAO inhibitor in the last 14 days. A harmful drug interaction could happen. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

You should not use PediaCare Children's Multi-Symptom Cold if you are allergic to dextromethorphan or phenylephrine.

Do not use PediaCare Children's Multi-Symptom Cold if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could happen. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

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

• high blood pressure;
• coronary artery disease (hardened arteries);
• diabetes;
• glaucoma;
• epilepsy or other seizure disorder;
• enlarged prostate or urination problems;
• pheochromocytoma (an adrenal gland tumor); or
• cough with mucus, or cough caused by emphysema or chronic bronchitis.

FDA pregnancy category C. It is not known whether PediaCare Children's Multi-Symptom Cold will harm an unborn baby. Do not use this medicine without a doctor's advice if you are pregnant.

Dextromethorphan and phenylephrine may pass into breast milk and may harm a nursing baby. Decongestants may also slow breast milk production. Do not use this medicine without a doctor's advice if you are breast-feeding a baby.

Artificially sweetened cold medicine may contain phenylalanine. If you have phenylketonuria (PKU), check the medication label to see if the product contains phenylalanine.

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

Stop using PediaCare Children's Multi-Symptom Cold and contact your doctor immediately if you experience:

• fast or uneven heart rate;
• severe dizziness or anxiety, feeling like you might faint;
• severe headache;
• changes in mood;
• fever; or
• dangerously high blood pressure (severe headache, blurred vision, ringing in your ears, anxiety, chest pain, uneven heartbeats, seizure).

Common side effects of PediaCare Children's Multi-Symptom Cold may include:

• diarrhea;
• dizziness, drowsiness;
• trouble sleeping (insomnia); or
• feeling nervous, restless, or irritable.

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

Since PediaCare Children's Multi-Symptom Cold is taken as needed, you might not have a regular dosing schedule. If you are taking the medication regularly and forget a dose, take it as soon as you remember. If it is almost time for your next scheduled dose, skip the missed dose. Do not take extra medicine to compensate for the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

PediaCare Children's Multi-Symptom Cold may cause blurred vision or affect your thinking or reactions. Be cautious if you drive or do anything that requires you to be alert and see clearly.

Drinking alcohol can increase some side effects of dextromethorphan and phenylephrine.

Ask a doctor or pharmacist before using any other cold, cough, or allergy medication. PediaCare Children's Multi-Symptom Cold is found in many combination medicines. Taking certain products together can lead to taking too much of a specific drug. Check the label to see if a medicine contains a decongestant or cough suppressant.

Ask a doctor or pharmacist before using this medicine if you are taking any other drugs, including prescription and over-the-counter medicines, vitamins, and herbal products. Some medicines can interact and cause unwanted or dangerous effects. Not all possible interactions are included in this medication guide.

Taking this medicine with other drugs that can make you sleepy or slow your breathing may increase these effects. Ask your doctor before using PediaCare Children's Multi-Symptom Cold with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.