Daytime

Acetaminophen is a medicine that relieves pain and reduces fever.

Dextromethorphan is a medicine that suppresses cough. It works on the brain to stop the cough reflex.

Phenylephrine is a decongestant that makes blood vessels in the nasal passages smaller. Enlarged blood vessels can lead to nasal congestion (stuffy nose).

Daytime is a combination medicine used to relieve headache, fever, body aches, cough, stuffy nose, and sinus congestion caused by allergies, the common cold, or the flu.

Daytime will not treat a cough caused by smoking, asthma, or emphysema.

Daytime may also be used for other reasons not listed 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.

Do not take more of this medication than recommended. An acetaminophen overdose can damage your liver or cause death.

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving cough or cold medicine to a child. Death can occur from the misuse of cough or cold medicine 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.

Dissolve one packet of the powder in at least 4 ounces of water. Stir this mixture and drink all of it right away.

Do not take for longer than 7 days in a row. Stop taking the medicine and call your doctor if you still have a fever after 3 days of use, you still have pain after 7 days (or 5 days if treating a child), if your symptoms get worse, or if you have a skin rash, ongoing headache, or any redness or swelling.

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 this medicine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could happen. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

Do not take more of this medication than is recommended. An overdose of acetaminophen can harm your liver or cause death. Call your doctor right away if you have nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of your skin or eyes).

In rare cases, acetaminophen may cause a severe skin reaction. Stop taking this medicine and call your doctor immediately if you have skin redness or a rash that spreads and causes blistering and peeling.

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

You should not use this medication if you are allergic to acetaminophen, dextromethorphan, or phenylephrine.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have other medical conditions, especially:

• liver disease, alcoholism, or if you drink more than 3 alcoholic beverages per day;
• high blood pressure, heart disease, coronary artery disease;
• asthma or COPD, cough with mucus, or cough caused by smoking, emphysema, or chronic bronchitis;
• diabetes;
• glaucoma;
• overactive thyroid;
• epilepsy or other seizure disorder;
• pheochromocytoma (an adrenal gland tumor); or
• bladder obstruction or other urination problems.

It is not known whether Daytime will harm an unborn baby. Do not use this medicine without a doctor's advice if you are pregnant.

Acetaminophen, 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 have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could happen even if you have taken acetaminophen before without any issues. Stop taking this medicine and call your doctor right away if you notice skin redness or a rash that spreads and causes blistering and peeling. If you experience this type of reaction, you should never take any medicine that contains acetaminophen again.

Daytime may cause serious side effects. Stop using Daytime and call your doctor immediately if you have:

• chest pain, fast, slow, or uneven heart rate;
• severe dizziness, feeling like you might faint;
• mood changes, confusion, hallucinations, seizure (convulsions);
• little or no urinating;
• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
• dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, chest pain, uneven heartbeats, seizure).

Common side effects of Daytime may include:

• dizziness, weakness, mild headache;
• diarrhea, upset stomach;
• dry mouth, nose, or throat;
• feeling nervous, restless, irritable, or anxious; or
• sleep problems (insomnia).

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.

Since Daytime is taken as needed, you might not follow a dosing schedule. If you are taking the medication regularly, take the missed dose 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 make up for the missed dose.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222. Taking too much acetaminophen can be deadly.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Overdose symptoms may also include severe versions of some of the side effects listed in this medication guide.

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medications. Acetaminophen (sometimes abbreviated as APAP) is found in many combination medicines. Taking certain products together can lead to getting too much acetaminophen, which can result in a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

This medication may affect your thinking or reactions. Be careful if you drive or do anything that needs you to be alert.

Avoid drinking alcohol. It may increase your risk of liver damage while you are taking acetaminophen.

Other drugs may interact with Daytime, including prescription and over-the-counter medicines, vitamins, and herbal products. Inform all your health care providers about all medicines you are currently using and any medicines you begin or discontinue.