This combination product is used to treat symptoms caused by the common cold, flu, allergies, hay fever, or other breathing illnesses (such as sinusitis, bronchitis). Guaifenesin is an expectorant that helps to thin and loosen mucus in the lungs, making it easier to cough up the mucus. Decongestants relieve stuffy nose symptoms. This product also contains an opioid cough suppressant (antitussive) that affects a certain part of the brain, reducing the urge to cough. Antihistamines relieve watery eyes, itchy eyes/nose/throat, runny nose, and sneezing.

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.

Opioid cough suppressants should not be used by children younger than 18 years. Children are at higher risk for serious (even fatal) side effects, especially breathing problems. Talk with the doctor about the risks and benefits of this medication.

Cough-and-cold products do not cure colds. Cough due to a common cold often does not need to be treated with medicine. Ask your 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 with a full glass of water (8 ounces or 240 milliliters) 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. This medication may be taken with food or milk if stomach upset occurs. Carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.

Do not increase your dose or use this product more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

If you suddenly stop using this medication, you may have withdrawal symptoms (such as restlessness, watering eyes, runny nose, nausea, sweating, muscle aches). To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used this medication regularly for a long time (more than a few weeks) or in high doses. Tell your doctor or pharmacist right away if you have withdrawal.

Though it helps many people, this product has a risk for abuse and may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Take this product exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details.

When used for an extended time, this medication may not work as well and may require different dosing. Talk with your doctor if this medication stops working well.

Tell your doctor if your cough does not get better in 5 days. Also, tell your doctor if your condition gets worse, or if you have a headache that doesn't go away, fever, or rash. These may be symptoms of a serious medical problem and should be checked by a doctor.

See also Warning section.

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, tell your doctor or pharmacist promptly.

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

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.

Remember that this medication has been prescribed because 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:

• interrupted breathing during sleep (sleep apnea)
• mental/mood changes (such as hallucinations)
• ringing in the ears
• shaking (tremors)
• trouble urinating
• weakness
• easy bruising/bleeding
• fast/slow/irregular heartbeat

Get medical help right away if you have any very serious side effects, including:

• seizure

This product may cause serious mental/mood changes and very serious (rarely fatal) breathing problems. This product may contain codeine or dihydrocodeine. Codeine and dihydrocodeine are changed into strong opioid drugs (morphine or dihydromorphine) in your body. In some people this happens faster and more completely than usual, which increases the risk of very serious side effects. Get medical help right away if you notice any of the following:

• slow/shallow breathing
• severe drowsiness/difficulty waking up
• confusion

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 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.

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

• abdominal problems (such as chronic constipation, ileus, gallbladder disease, pancreatitis)
• adrenal gland problem (such as Addison's disease)
• certain brain disorders (such as head injury, tumor, increased intracranial pressure)
• breathing problems (such as asthma, emphysema, sleep apnea)
• diabetes
• a certain eye problem (glaucoma)
• heart problems
• high blood pressure
• kidney problems
• liver disease
• mental/mood problems (such as depression, psychosis)
• seizures
• stomach/intestinal problems (such as ulcers, blockage)
• thyroid problems (such as hyperthyroidism, hypothyroidism)
• urination problems (such as trouble urinating due to enlarged prostate, urinary retention)
• personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol)
• obesity

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

This medication 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 confusion, dizziness, drowsiness, and slow/shallow breathing.

Tell your doctor if you are pregnant or think you may be pregnant. During pregnancy, this product is not recommended. It may harm an unborn baby. Talk to your doctor about the risks and benefits of this medication. See also Warning section.

This product may pass into breast milk and may have undesirable effects on a nursing infant (such as unusual sleepiness, difficulty feeding, trouble breathing, or unusual limpness). Consult your doctor before breastfeeding.

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.

Some products that may interact with this drug include:

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

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 may be available in many prescription and nonprescription products. Check the labels on all your medications carefully to make sure you are not taking more than one product with the same ingredient(s). Consult your pharmacist if you are unsure of the ingredients in any of your medications.

The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also cause drowsiness or breathing problems. Tell your doctor or pharmacist if you are taking other products such as other 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.

Other medications can affect the removal of this product from your body, which may affect how this product works. Examples include azole antifungals (such as ketoconazole), bupropion, fluoxetine, macrolide antibiotics (such as erythromycin), paroxetine, quinidine, rifamycins (such as rifabutin, rifampin), ritonavir, certain drugs used to treat seizures (such as carbamazepine, phenytoin), among others.

This medication may interfere with certain lab tests (such as 5-HIAA levels, VMA levels, amylase/lipase levels, allergy skin test), 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: confusion, flushing, hallucinations, cold/clammy skin, slow/shallow breathing, fast/slow/irregular heartbeat, seizures. In children, excitement may occur first, and may be followed by loss of coordination, drowsiness, coma, seizures, slow/shallow/noisy breathing.

Do not share this medication with others. Sharing it is against the law.

If you are prescribed this medication 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.

Store at room temperature away from light and moisture. Do not store in the bathroom. Do not freeze. 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.