This combination medication is used to temporarily treat symptoms caused by the common cold, flu, allergies, or other breathing illnesses (such as sinusitis, bronchitis). Decongestants help relieve stuffy nose, sinus, and ear congestion symptoms. Acetaminophen (APAP) is a non-aspirin pain reliever and fever reducer. Antihistamines help 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. Therefore, 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).
Drowsiness, dizziness, blurred vision, upset stomach, nausea, nervousness, or dry mouth/nose/throat may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
If your doctor has prescribed this medication, remember that he or she 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 any of these unlikely but serious side effects occur: mental/mood changes (such as confusion, hallucinations), shaking, trouble urinating.
Tell your doctor right away if any of these rare but serious side effects occur: fast/slow/irregular heartbeat, seizure.
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.
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, kidney problems, liver disease, seizures, stomach/intestinal problems (such as blockage, constipation, ulcers), 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. 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.
Children may be more sensitive to the effects of this drug. In young children, antihistamines may cause agitation/excitement instead of drowsiness.
Older adults may be more sensitive to the effects of this drug, especially dizziness, drowsiness, confusion, constipation, trouble urinating, fast/irregular heartbeat, or trouble sleeping. Dizziness, drowsiness, trouble sleeping, and confusion can increase the risk of falling.
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 and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.