DECONGESTANT/ACETAMINOPHEN - ORAL

DECONGESTANT/ACETAMINOPHEN - ORAL

PHONETIC PRONUNCIATION:

GENERIC NAME(S): phenylephrine HCl/acetaminophen

Uses

USES: 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. 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).


How to use DECONGESTANT/ACETAMINOPHEN - ORAL

HOW TO USE: See also Warning section. Read and follow all directions on the package label. Do not give children medicines labeled only for adults. If you have any questions, consult your pharmacist. Take this medication by mouth with or without food, usually every 4 to 6 hours as needed or as directed by your doctor. 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. The dosage is based on your age, medical condition, and response to treatment. Do not increase your dose, take it more frequently, or use it for a longer time than directed. Tell your doctor if your condition persists for more than 1 week, if it worsens, or if it occurs with rash, persistent headache, or fever lasting more than 3 days. These may be symptoms of a serious medical problem and should be checked by a doctor.

Side Effects

SIDE EFFECTS: See also Warning section. Upset stomach, nausea, dizziness, trouble sleeping, or nervousness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Tell your doctor right away if any of these unlikely but serious side effects occur: mental/mood changes (such as confusion, hallucinations), fast/irregular heartbeat, problems urinating. 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. 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

PRECAUTIONS: See also Warning section. 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, liver disease, overactive thyroid (hyperthyroidism), urination problems (such as trouble urinating due to enlarged prostate, urinary retention). This drug may make you dizzy. Alcohol or marijuana can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana. 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. Caution is advised when using this product in children because they may be more sensitive to its side effects, especially excitation and agitation. 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. This medication may pass into breast milk. Consult your doctor before breast-feeding.

Interactions

DRUG INTERACTIONS: 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. A products that may interact with this drug is: ketoconazole. Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, 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 medicines (such as pain/fever drugs, diet aids, or cold/allergy products) because they may contain the same or similar ingredients. Using these drugs along with this product could increase side effects (such as fast heartbeat or increased blood pressure). Ask your pharmacist about using those products safely. This medication may interfere with certain laboratory tests (including urine 5-HIAA), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

Overdose

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. Canada residents can call a provincial poison control center. Symptoms of overdose may include: fast/irregular heartbeat, nausea, vomiting, loss of appetite, sweating, stomach/abdominal pain, extreme tiredness, yellowing eyes/skin, dark urine, hallucinations, seizures.

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Faq for DECONGESTANT/ACETAMINOPHEN - ORAL

Decongestant/acetaminophen is typically used to relieve symptoms of common cold and flu, such as nasal congestion, sinus pressure, headache, and fever.

Decongestant/acetaminophen works by constricting blood vessels in the nasal passages, reducing inflammation and relieving congestion. Acetaminophen helps to reduce fever and alleviate pain.

It is not recommended to take decongestant/acetaminophen if you have high blood pressure or other cardiovascular conditions without consulting your doctor. Decongestants can raise blood pressure, so alternative options may be recommended.

Common side effects may include nervousness, dizziness, headache, increased heart rate, upset stomach, and trouble sleeping. If you experience any severe or persistent side effects, seek medical attention.

Certain medications may interact with decongestant/acetaminophen, including monoamine oxidase inhibitors (MAOIs), antidepressants, and some blood pressure medications. It is important to consult your healthcare provider or pharmacist before taking any additional medications.

Decongestant/acetaminophen is typically recommended for short-term use only, usually for a maximum of 7-10 days. Prolonged use may lead to dependence or worsen symptoms. If your symptoms persist, consult a healthcare professional.

It is advisable to consult a healthcare provider before taking decongestant/acetaminophen during pregnancy or while breastfeeding. Some ingredients may not be suitable or safe for these conditions.

If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not double the dose to make up for a missed one.

It is generally recommended to avoid alcohol while taking decongestant/acetaminophen as it can increase the risk of liver damage and other side effects. Alcohol may also interact with the medication, affecting its effectiveness.


Warning

WARNING: One ingredient in this product is acetaminophen. Taking too much acetaminophen may cause serious (possibly fatal) liver disease. Adults should not take more than 4000 milligrams (4 grams) of acetaminophen a day. People with liver problems and children should take less acetaminophen. Ask your doctor or pharmacist how much acetaminophen is safe to take. Do not use with any other drug containing acetaminophen without asking your doctor or pharmacist first. Acetaminophen is in many nonprescription and prescription medications (such as pain/fever drugs or cough-and-cold products). Check the labels on all your medicines to see if they contain acetaminophen, and ask your pharmacist if you are unsure. Get medical help right away if you take too much acetaminophen (overdose), even if you feel well. Overdose symptoms may include nausea, vomiting, loss of appetite, sweating, stomach/abdominal pain, extreme tiredness, yellowing eyes/skin, and dark urine Daily alcohol use, especially when combined with acetaminophen, may damage your liver. Avoid alcohol.


Disclaimer

IMPORTANT: 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.