Sudafed Sinus Congestion+Cold Severe Day and Night

Acetaminophen is a medicine that helps relieve pain and reduce fever.

Diphenhydramine is an antihistamine that helps lessen the effects of the body's natural chemical histamine. Histamine can cause symptoms like sneezing, itching, watery eyes, and a runny nose.

Pseudoephedrine is a decongestant that narrows blood vessels in the nasal passages. Widened blood vessels can lead to nasal congestion (a stuffy nose).

Sudafed Sinus Congestion+Cold Severe Day and Night is a combination medicine used in adults and children who are at least 12 years old to temporarily relieve cold and flu symptoms such as body aches, headache, sore throat, sinus congestion, sneezing, runny or stuffy nose, and fever.

Sudafed Sinus Congestion+Cold Severe Day and Night may also be used for reasons not mentioned in this medication guide.

Use exactly as directed on the label, or as prescribed by your doctor. An acetaminophen overdose can harm your liver or lead to death.

Do not take this medicine for longer than 10 days without your doctor's advice.

Call your doctor if you still have a sore throat after 2 days, or if you also have a fever, headache, nausea, vomiting, or rash.

Store at room temperature away from moisture and heat. Keep each tablet in the blister pack until you are ready to take a dose.

Do not use this medicine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Call your doctor at once if you have loss of appetite, nausea, vomiting, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

In rare cases, acetaminophen may cause a severe skin reaction. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.

You should not use acetaminophen, diphenhydramine, or pseudoephedrine if you are allergic to them or any of their ingredients.

Do not use Sudafed Sinus Congestion+Cold Severe Day and Night if you have used an MAO inhibitor in the last 14 days. This could lead to a dangerous drug interaction. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, and tranylcypromine. Wait at least 14 days after stopping an MAO inhibitor before taking this medicine.

Ask a doctor, pharmacist, or other healthcare provider if it is safe for you to use this product if you have or have ever had:

• a breathing disorder or problems such as emphysema or chronic bronchitis;
• high blood pressure, heart disease;
• enlarged prostate or urination problems;
• glaucoma;
• diabetes;
• a thyroid disorder;
• if you use a blood thinner (such as warfarin), sedatives, tranquilizers, or other opioid medicines; or
• liver disease, alcoholism, or if you drink more than 3 alcoholic beverages per day.

Ask a doctor before using Sudafed Sinus Congestion+Cold Severe Day and Night if you are pregnant or breastfeeding.

Do not give this medicine to children under 12 years of age without medical advice.

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

In rare cases, acetaminophen may cause a severe skin reaction that can be fatal, even if you have taken acetaminophen in the past without any reaction. Stop taking this medicine and call your doctor right away if you notice skin redness or a rash that spreads and causes blistering and peeling.

Stop taking Sudafed Sinus Congestion+Cold Severe Day and Night and call your doctor immediately if you have:

• any new symptoms;
• nervousness, dizziness, or trouble sleeping;
• pain or nasal congestion that gets worse or lasts longer than 7 days;
• fever that gets worse or lasts longer than 3 days; or
• redness or swelling.

Common side effects of Sudafed Sinus Congestion+Cold Severe Day and Night may include:

• feeling restless or excited (especially in children).

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sudafed Sinus Congestion+Cold Severe Day and Night is used as needed. If you are following a dosing schedule, skip any missed dose. Do not use two doses at the same time.

Seek emergency medical attention or call the Poison Help line at 1 800 222 1222. Taking too much acetaminophen can be deadly.

Signs of an overdose include vomiting, stomach pain, and yellowing of your skin or eyes.

Do not use with any other medicine that has acetaminophen (sometimes called APAP) or diphenhydramine, including creams or ointments for the skin.

Ask a doctor or pharmacist if you are unsure whether a medicine has acetaminophen or diphenhydramine.

Drinking alcohol may raise your risk of liver damage while taking acetaminophen and may also enhance some side effects of diphenhydramine.

Avoid driving or doing anything dangerous until you know how Sudafed Sinus Congestion+Cold Severe Day and Night will affect you. Your reactions may be affected.

Ask a doctor or pharmacist before using any other medicines that can cause drowsiness (such as opioid medication, sleep medicine, a muscle relaxer, or medicine for anxiety or seizures). Inform your doctor about all other medicines you are taking. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.