This combination medication is used to temporarily treat cough and runny/stuffy nose (nasal congestion) caused by infections (such as the common cold), allergies (such as hay fever), and other breathing illnesses. This product is usually not used for ongoing cough from smoking or long-term breathing problems (such as chronic bronchitis, emphysema) unless directed by your doctor. Guaifenesin is an expectorant. It works by thinning and loosening mucus in the airways, clearing congestion, and making breathing easier. Phenylephrine is a decongestant (sympathomimetic). It reduces nasal congestion by narrowing the blood vessels in the nose.

If you are self-treating with this medication, it is important to read the package instructions carefully before you start using this product to be sure it is right for you. (See also Precautions section.)

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 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).

Take this medication by mouth with or without food, as directed by your doctor. If you are self-treating, follow all directions on the product package. To prevent trouble sleeping, do not take this medication close to bedtime. If you have any questions, ask your doctor or pharmacist.

The dosage is based on your age, medical condition, and response to treatment. Do not increase your dose or take this drug more often than directed.

Guaifenesin may have a bitter taste. Swallow capsules and tablets whole. Scored tablets may be split for lower doses. Chewable tablets may be swallowed whole or chewed.

Drink plenty of fluids while taking this medication. Fluids will help to break up mucus and clear congestion.

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.

Tell your doctor if your condition is accompanied by headache that doesn't go away, fever, severe sore throat, rash, or if it lasts, returns, or gets worse after 7 days. These may be signs of a serious medical problem. Get medical help right away if you think you may have a serious medical problem.

Nausea or headache may occur. If either of these effects lasts or gets worse, tell your doctor or pharmacist promptly.

If your doctor has directed you to use 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:

• dizziness
• fainting
• shaking (tremor)
• fast/irregular/pounding heartbeat
• difficult/painful urination
• mental/mood changes (such as confusion, nervousness, irritability)
• trouble sleeping
• seizures

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.

Before taking this medication, tell your doctor or pharmacist if you are allergic to phenylephrine or guaifenesin; or if you have any other allergies. Also tell your doctor if you have had bad reactions to similar drugs (sympathomimetics such as ephedrine). 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 emphysema, chronic bronchitis, asthma, smoker's cough)
• cough with blood or large amounts of mucus
• high blood pressure
• heart disease (such as chest pain, heart failure, heart attack)
• fast/slow/irregular heartbeat
• diabetes
• a certain eye problem (glaucoma)
• difficulty urinating (such as due to enlarged prostate)
• overactive thyroid (hyperthyroidism)

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. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

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

Liquid forms of this product may contain sugar, aspartame, and/or alcohol. Caution is advised if you have diabetes, 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.

Children may be more sensitive to the side effects of this drug, especially nervousness, irritability, and high blood pressure.

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.

It is unknown if guaifenesin passes into breast milk. Phenylephrine passes into breast milk. Consult your doctor before breastfeeding.

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 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.

Guaifenesin and phenylephrine are available in both prescription and nonprescription products. Check the labels of all your medications to make sure you are not taking more than one product containing guaifenesin or phenylephrine.

Guaifenesin may interfere with certain lab tests (such as urine levels of certain acids), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

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 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: severe dizziness/fainting, fast irregular heartbeat, slow/fast/shallow breathing, hallucinations, seizures.

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

Keep all medical and lab appointments.

If you 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.

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.