When This Medicine Should Not Be Used:
You should not use this medicine if you have ever had an allergic reaction to a decongestant or pain medicine. Some of these medicines may contain aspirin and should not be given to children under age 16. Aspirin can cause a serious disease called Reye's syndrome in children and teenagers who have chicken pox, flu, or similar infections. You should not use this medicine if you have used an MAO inhibitor such as 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:
Tablet, Packet, Chewable Tablet, Fizzy Tablet, Tablet, Capsule, Liquid Filled Capsule, Liquid, Powder

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Follow the instructions on the medicine label if you are using this medicine without a prescription.
• It is not safe to take more than 4 grams (4,000 milligrams) of acetaminophen in one day (24 hours).
• You may take your medicine with food or milk to avoid stomach upset.
• If you use the tablet, capsule, extended-release tablet, or liquid-filled capsule, swallow the pill whole. Do not crush, break, or chew (unless the medicine label says "chewable").
• Measure the oral liquid medicine with a marked measuring spoon, oral syringe, medicine dropper, or medicine cup. You might need to shake the medicine just before you use it.
• If you use powder or 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.

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

• Make sure your doctor knows if you are also using medicine for high blood pressure or depression, a blood thinner such as Coumadin®, or an MAO inhibitor (Nardil®, Marplan®, Parnate®, Eldepryl®).
• Avoid drinking alcohol or using diet pills (Accutrim®, Dexatrim®) while using this medicine.
• 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 contain acetaminophen.
• Avoid using sleeping pills, other cold or allergy medicine, sedatives, muscle relaxants, tranquilizers, or narcotic pain killers unless approved by your doctor.

Warnings While Using This Medicine:

• If you are pregnant or breastfeeding, talk to your doctor before using this medicine.
• Make sure your doctor knows if you have heart disease, high blood pressure, diabetes, an enlarged prostate, or an overactive thyroid.
• This medicine might contain phenylalanine. This is only a concern if you have a disorder called phenylketonuria (a problem with amino acids). Talk to your doctor before using this medicine.
• Call your doctor if your symptoms get worse after 2 or 3 days of treatment, or if they do not improve after 7 days. Also call if you develop a severe sore throat or fever; or cough up thick yellow mucus.
• If you are allergic to aspirin, you may also be allergic to ibuprofen. Read the medicine label carefully to see if your medicine has ibuprofen in it, or ask your pharmacist.
• If your medicine contains aspirin and has a vinegar smell, you should not use it.
• This medicine may make you restless. If you have trouble sleeping, take your medicine well before bedtime.
• Children may be more sensitive to this medicine than adults, especially if they use too much medicine. Always read medicine labels closely to give your child the right amount. If you are not sure how much medicine to use, ask your pharmacist.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Red or brown, grainy vomit
• Black stools
• Ringing or buzzing in the ears
• Fast, pounding, or irregular heartbeat
• Trouble breathing
• Severe headache

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

• Restlessness
• Trouble sleeping
• Stomach upset
• Painful or difficult urination
• Headache

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