Analgesic/antihistamine/antitussive (By mouth)

Introduction

Treats minor sore throat, cough, body aches, runny nose, and fever.

Brand Name(s)

Vicks Formula 44 Custom Care Cough & Cold PM, Diabetic Tussin Nighttime Cold and Flu, All-Nite, Good Neighbor Pharmacy Night Time Cold & Flu, Good Neighbor Pharmacy Night Time, Nighttime, Quality Choice NightTime Cold Medicine, Leader Nite Time, Rite Aid Nite Time Cold/Flu Formula, TopCare Nite Time, TopCare Nite Time Cold & Flu, Rite Aid Cold & Flu Relief, Delsym Night Time Multi-Symptom, Good Sense Night Time Cold & Flu Relief, Vicks Alcohol Free NyQuil Cold & Flu

There may be other brand names for this medicine.

When This Medicine Should Not Be Used

You should not use this medicine if you have had an allergic reaction to any type of cold medicine. Do not use this medicine if you have taken an MAO inhibitor such as Eldepryl®, Marplan®, Nardil®, or Parnate® within the past 14 days. Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years old. Using these medicines in very young children might cause serious or possibly life-threatening side effects.

How to Use This Medicine

Capsule, Liquid, Tablet, Liquid Filled Capsule

• Your doctor will tell you how much of this medicine to take and how often. Do not take more medicine or take it more often than your doctor tells you to. It is not safe to take more than 4 grams (4,000 milligrams) of acetaminophen in one day (24 hours).
• If you are using this medicine without a prescription, follow the instructions on the medicine label.
• Do not take more than 4 doses of this medicine (8 tablespoons) in one day.
• Measure this medicine with the medicine cup provided in the package, or with a marked measuring spoon or oral syringe.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not drink alcohol while you are using this medicine. Acetaminophen can damage your liver and drinking alcohol can increase this risk. If you regularly drink 3 or more alcoholic drinks every day, do not take acetaminophen without asking your doctor.
• Do not also use other medicines that contain acetaminophen, or you may be getting more than a safe amount of this medicine. Many combination medicines contain acetaminophen, including products with brand names such as Alka-Seltzer Plus®, Comtrex®, Drixoral®, Excedrin Migraine®, Midol®, Sinutab®, Sudafed®, Theraflu®, and Vanquish®. Carefully check the labels of all other medicines you are using to be sure they do not also contain acetaminophen.
• Tell your doctor if you are using any medicines that make you sleepy. These include sleeping pills, cold and allergy medicine, narcotic pain relievers, and sedatives.

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breastfeeding. Tell your doctor if you smoke or have asthma, emphysema, bronchitis, or a chronic cough.
• Do not give this medicine to a child under 12 years old unless your doctor tells you to.
• If your symptoms do not improve or if they get worse, call your doctor.
• This medicine may make you dizzy or drowsy. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Dark-colored urine or pale stools.
• Fever that lasts longer than 3 days.
• Lightheadedness, fainting, weakness, sweating.
• Nausea, vomiting, loss of appetite, pain in your upper stomach.
• Ongoing cough with headache and skin rash.
• Redness, swelling, or any new symptoms.
• Unusual bleeding or bruising.
• Vomiting blood or material that looks like coffee grounds.
• Yellowing of your skin or the whites of your eyes.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088