dexbrom 1 mg-pseudoephed 30 mg-chlophedianol 12.5 mg/5 mL oral liquid

Generic name:
Non-opioid antitussive/decongestant/antihistamine - oral

This combination medication is used to relieve symptoms caused by the common cold, flu, allergies, "hay fever," and other breathing illnesses (such as sinusitis, bronchitis). These symptoms include cough, watery eyes, itchy eyes/nose/throat, runny nose, and sneezing. This product contains a cough suppressant (such as chlophedianol) that affects a certain part of the brain, reducing the urge to cough. This product also contains a decongestant (such as pseudoephedrine, phenylephrine), which helps relieve stuffy nose symptoms. It also contains an antihistamine (such as brompheniramine, triprolidine, among others), which helps relieve watery eyes, itchy eyes/nose/throat, runny nose, and sneezing.

This medication is not usually used for ongoing coughs from smoking, asthma, or other long-term breathing problems (such as emphysema), or for 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).

Take this medication by mouth with or without food. If stomach upset occurs, take this product with food or milk. 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.

The dosage is based on your age, medical condition, and response to treatment. Long-acting products are usually taken twice a day. Some products may be taken every 4 to 6 hours as needed. Follow your doctor's directions carefully. Do not increase your dose or take this medication more often than prescribed without your doctor's approval. If you are taking this medication for allergy or hay fever, take it regularly to get the most benefit from it.

If you are using the liquid form, use a medication-measuring device or spoon to carefully measure the prescribed dose. 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.

If you are using the chewable form, chew the tablets thoroughly before swallowing.

Tell your doctor if your condition lasts for more than 1 week, if it gets worse, or if it occurs with 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.

Drowsiness, dizziness, flushing, headache, nausea, nervousness, blurred vision, 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.

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:

• mental/mood changes (such as hallucinations, confusion)
• shaking (tremors)
• trouble urinating
• weakness

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

• 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.

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

• breathing problems (such as asthma, emphysema)
• diabetes
• glaucoma
• heart problems
• high blood pressure
• seizures
• overactive thyroid (hyperthyroidism)
• kidney problems
• 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).

Some brands 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 about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

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

Older adults may be more sensitive to the side effects of this drug, especially dizziness, drowsiness, mental/mood changes, and blood pressure changes.

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

This drug may pass into breast milk and could have undesirable effects on a nursing infant. 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.

Some products that may interact with this drug are:

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

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 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.

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 lab tests (such as 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: large pupils, flushing, shaking (tremor), hallucinations, confusion, seizures. In children, excitement may occur first, and may be followed by loss of coordination, drowsiness, loss of consciousness, seizures.

Do not share this medication with others.

If your doctor directs you to take this medication on a regular schedule and 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.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.