Uses

This combination medication is used to temporarily treat symptoms caused by the common cold, flu, allergies, or other breathing illnesses (such as sinusitis, bronchitis). The expectorant helps thin and loosen mucus in the lungs, making it easier to cough up the mucus. Decongestants help relieve stuffy nose, sinus, and ear congestion symptoms. Acetaminophen (APAP) is a non-aspirin pain reliever and fever reducer.

This medication is not usually used for ongoing coughs from smoking, asthma, other long-term breathing problems (such as emphysema), or coughs with a lot of mucus unless directed by your doctor.

Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Do not use this product to treat cold symptoms in children younger than 6 years unless specifically directed by the doctor. Some products (such as long-acting tablets/capsules) are not recommended for use in children younger than 12 years. Ask your doctor or pharmacist for more details about using your product safely.

These products do not cure or shorten the length of the common cold and may cause serious side effects. To decrease the risk for serious side effects, carefully follow all dosage directions. Do not use this product to make a child sleepy. Do not give other cough-and-cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask the doctor or pharmacist about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray).

How To Use

See also Warning section.

Read and follow all directions on the package label. If you have any questions, consult your pharmacist.

Take this medication by mouth with or without food, usually every 4 to 6 hours as needed or as directed by your doctor. Drink plenty of fluids when you use this medication unless otherwise directed by your doctor. The fluid will help loosen the mucus in your lungs.

If you are using the liquid form of this medication, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose. If your liquid form is a suspension, shake the bottle well before each dose.

The dosage is based on your age, medical condition, and response to treatment. Do not increase your dose, take it more frequently, or use it for a longer time than directed. Do not give children medicines labeled only for adults.

Tell your doctor if your condition persists for more than 1 week, if it worsens, or if it occurs with rash, persistent headache, or fever lasting more than 3 days. These may be symptoms of a serious medical problem and should be checked by a doctor.

Side Effects

See also Warning section.

Upset stomach, nausea, dizziness, trouble sleeping, or nervousness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Tell your doctor right away if any of these unlikely but serious side effects occur:

• mental/mood changes (such as confusion, hallucinations)
• fast/irregular heartbeat
• problems urinating

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

See also Warning section.

Before taking this product, tell your doctor or pharmacist if you are allergic to any of its ingredients; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

If you have any of the following health problems, consult your doctor or pharmacist before using this medication:

• breathing problems (such as asthma, emphysema)
• diabetes
• glaucoma
• heart problems
• high blood pressure
• liver disease
• overactive thyroid (hyperthyroidism)
• urination problems (such as trouble urinating due to enlarged prostate, urinary retention)

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Some brands of this product may contain sugar, alcohol, or aspartame. Caution is advised if you have diabetes, alcohol dependence, liver disease, phenylketonuria (PKU) or any other condition that requires you to limit/avoid these substances in your diet. Ask your doctor or pharmacist about using this product safely.

Before having surgery, tell your doctor or dentist that you are taking this medication.

Caution is advised when using this product in infants or children because they may be more sensitive to its side effects, especially excitation and agitation.

Older adults may be more sensitive to the side effects of this drug, especially fast/irregular heartbeat, dizziness, problems urinating, trouble sleeping, or confusion.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication may pass into breast milk. Consult your doctor before breast-feeding.

Drug Interactions

See also Warning section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

A product that may interact with this drug is:

• ketoconazole

Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, metaxalone, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication. Ask your doctor when to start or stop taking this medication.

The ingredients in this product are available in many prescription and nonprescription products. Check the labels on all your medicines (such as pain/fever drugs, diet aids, or cold/allergy products) because they may contain the same or similar ingredients. Using these drugs along with this product could increase side effects (such as fast heartbeat or increased blood pressure). Ask your pharmacist about using those products safely.

This medication may interfere with certain laboratory tests (including urine 5-HIAA), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 9-1-1. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: fast/irregular heartbeat, nausea, vomiting, loss of appetite, sweating, stomach/abdominal pain, extreme tiredness, yellowing eyes/skin, dark urine, hallucinations, seizures.

Notes

Keep all regular medical and laboratory appointments.

Missed Dose

If you are taking this product on a regular schedule and miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Storage

Store in a tightly closed container at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.