Analgesic/antihistamine/antitussive/decongestant (By mouth)

Introduction

Treats fever, headache, sore throat, body aches, sneezing, runny and stuffy nose, cough, and itchy eyes caused by hay fever, colds, or flu.

Brand Name(s)

Vicks Nyquil Multi-Symptom, Contac Severe Cold & Flu, Theraflu Nighttime Maximum Strength, Comtrex Cold & Cough, Comtrex Cold & Cough Nighttime, Co-APAP, Contac Day/Night Cold & Flu, Kolephrin/DM, Comtrex Nighttime Cold & Cough, Tylenol Cold Head Congestion, Comtrex Nightime Cold & Cough, Rite Aid Multi-Symptom Cold NightTime, Theraflu Nighttime Severe Cold, Good Neighbor Pharmacy Cold Multi-Symptom, TopCare Cold Head Congestion

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 acetaminophen (Tylenol®), or to any other ingredients in the medicine you are using. You should not use this medicine if you have taken medicine for depression such as a MAO inhibitor (Nardil®, Marplan®, Eldepryl®, 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, Long Acting Tablet, Long Acting Capsule, Liquid Filled Capsule, Tablet, Fizzy Tablet, Chewable Tablet, Liquid

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• If you are using this medicine without a prescription, follow the instructions on the medicine label.
• Completely chew the chewable tablet before swallowing it.
• Measure the oral liquid medicine with a marked measuring spoon, oral syringe, or medicine cup. You may need to shake the medicine container before you open it.
• If you use an effervescent tablet, stir the medicine into water and drink it right away. You must use at least 4 ounces (1/2 cup) of water to dissolve the effervescent tablet. Do not keep any mixture to take later.
• Swallow the extended-release tablet whole. Do not crush, break, or chew it.

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. Keep all medicine away from children and never share your medicine with anyone.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.

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 also use other medicines that contain acetaminophen, a cough suppressant, a decongestant, or an antihistamine (including medicine used on the skin). You may be getting more than a safe amount of these medicines.
• 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.
• Do not drink alcohol while you are using this medicine. Acetaminophen can damage your liver, and alcohol can increase this risk. If you regularly drink three or more alcoholic drinks every day, do not take any medicines that contain acetaminophen without asking your doctor.

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
• Nervousness, dizziness, or trouble sleeping.
• Your symptoms do not get better or they get worse after a week of using this medicine.

If you notice these less serious side effects, talk with your doctor:

• Dry mouth, nose, or throat.
• Nausea.
• Trouble urinating.

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

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breast feeding, or if you have heart disease, high blood pressure, diabetes, glaucoma, asthma, emphysema or other serious lung problems, an enlarged prostate that causes urinary blockage, or thyroid problems. Tell your doctor if you have had an allergic reaction to any cough, allergy, or cold medicine, or to any pain reliever. Make sure your doctor knows if you drink alcohol on a regular basis.
• Do not use this medicine for a chronic (long-term) cough, unless your doctor says it is OK. Do not use this medicine if your cough brings up a lot of phlegm (mucus), unless your doctor tells you to.
• This medicine might contain phenylalanine (aspartame). This is only a concern if you have a disorder called phenylketonuria (PKU), which is a problem with amino acids. Talk to your doctor before using this medicine if you have PKU.
• If your symptoms get worse or do not improve within 7 days, or if your cough comes back, call your doctor. Also tell your doctor if you have a fever that lasts for more than 3 days, or if you have a fever with rash, cough, or a lasting headache. Make sure your doctor knows if you have redness or swelling.
• Call your doctor if you have a sore throat that is severe, lasts for more than 2 days, or happens with or before a fever, headache, rash, nausea, or vomiting.
• This medicine can make you drowsy or restless. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert. Avoid taking at bedtime if it makes you restless.
• Children may be more sensitive to this medicine than adults, especially if they take too much. Always read the medicine label closely so you give your child the right amount. Ask your pharmacist or doctor if you are not sure how much medicine to give your child.