Uses

This combination medication is used to treat symptoms caused by the common cold, flu, allergies, hay fever, or other breathing illnesses (such as sinusitis, bronchitis). Dextromethorphan is a cough suppressant that affects a certain part of the brain (cough center), reducing the urge to cough. Decongestants help relieve stuffy nose symptoms. Antihistamines relieve watery eyes, itchy eyes/nose/throat, runny nose, and sneezing.

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

If you are taking the over-the-counter product, read all directions on the product package before taking this medication. If you have any questions, consult your pharmacist. If your doctor has prescribed this medication, take it as directed.

Take this medication by mouth with or without food with a full glass of water (8 ounces or 240 milliliters) or as directed by your doctor. This medication may be taken with food or milk if stomach upset occurs.

If you are using the liquid form, use a medication measuring device to carefully measure the prescribed dose. Do not use a household spoon. If your liquid form is a suspension, shake the bottle well before each dose.

If you are taking the extended-release capsules, swallow them whole. Do not crush or chew extended-release capsules or tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split extended-release tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing.

Chewable forms of this medication should be chewed thoroughly before swallowing.

If you are taking the powder, mix it thoroughly in the proper amount of liquid and stir well. Drink all of the liquid right away. Do not prepare a supply for future use.

The dosage is based on your age, medical condition and response to therapy. If you are taking this medication for allergy or hay fever symptoms, take it regularly in order to get the most benefit from it.

Improper use of this medication (abuse) may result in serious harm (such as brain damage, seizure, death). Do not increase your dose, take it more often, or use it for a longer time than directed.

Tell your doctor if your condition lasts or gets worse.

Side Effects

Drowsiness, dizziness, headache, blurred vision, upset stomach, nausea, constipation, or dry mouth/nose/throat may occur. If any of these effects last or get worse, notify your doctor or pharmacist promptly.

To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute. This medication can dry up and thicken mucus in your lungs, making it more difficult to breathe and clear your lungs. To help prevent this effect, drink plenty of fluids unless otherwise directed by your doctor.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

If your doctor has prescribed this medication, remember that your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• mental/mood changes (such as confusion, hallucinations)
• ringing in the ears
• shaking (tremors)
• trouble urinating
• weakness
• easy bruising/bleeding
• fast/slow/irregular heartbeat
• seizure

A very serious allergic reaction to this drug is rare. However, get medical help right away 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

Before taking this product, tell your doctor or pharmacist if you are allergic to it; 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.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• breathing problems (such as asthma, emphysema)
• diabetes
• a certain eye problem (glaucoma)
• heart problems
• high blood pressure
• kidney problems
• liver disease
• seizures
• stomach/intestinal problems (such as ulcers, blockage)
• overactive thyroid (hyperthyroidism)
• urination problems (such as trouble urinating due to enlarged prostate, urinary retention)

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

This medicine may contain aspartame. If you have phenylketonuria (PKU) or any other condition that requires you to restrict your intake of aspartame (or phenylalanine), consult your doctor or pharmacist regarding the safe use of this medicine.

Liquid preparations of this product may contain sugar and/or alcohol. Caution is advised if you have diabetes, alcohol dependence, or liver disease. Ask your doctor or pharmacist about the safe use of this product.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially dizziness, drowsiness, mental/mood changes, constipation, fast heartbeat, trouble urinating, or blood pressure changes. Dizziness, drowsiness, and confusion can increase the risk of falling.

Children may be more sensitive to the side effects of antihistamines. In young children, this medication may cause agitation/excitement instead of drowsiness.

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

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.

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

Some products that may interact with this drug are:

• antihistamines applied to the skin (such as diphenhydramine cream, ointment, spray)
• rolapitant

Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or other antihistamines (such as cetirizine, diphenhydramine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

This medication may interfere with certain medical/lab tests (such as brain scan for Parkinson's disease, urine drug screening tests, allergy skin test), possibly causing false test results. Make sure lab 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 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center. Symptoms of overdose may include: agitation, confusion, flushing, hallucinations, large pupils, muscle twitching, seizures. In children, excitement may occur first, and may be followed by loss of coordination, drowsiness, loss of consciousness, seizures.

Notes

If your doctor has prescribed this medication, do not share it with others.

Keep all medical and lab 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.

If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Do not freeze liquid forms of this medication. Keep all medications 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.