When This Medicine Should Not Be Used:
You should not use this medicine if you have ever had an allergic reaction to pain medicine or antihistamines. 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 taken an MAO inhibitor such as Nardil®, Marplan®, 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, Capsule, Liquid

• Your doctor will tell you how much medicine to take and how often.
• Always follow dose instructions on the label when taking this medicine in over-the-counter form. Ask your doctor or pharmacist if you have questions about how much to take.
• Take this medicine exactly as your doctor ordered.
• Swallow the pill whole. Do not crush, break, or chew. You may take your medicine with food or milk to avoid stomach upset.

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 taking medicine for high blood pressure or depression, diet pills (Accutrim®, Dexatrim®), or monamine oxidase (MAO) inhibitors (Nardil®, Marplan®, Parnate®).
• Avoid drinking alcohol while taking this medicine.
• Avoid taking 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 taking this medicine.
• Before taking this medicine, let your doctor know if you have heart disease, high blood pressure, seizure disorders, asthma, emphysema, diabetes, an enlarged prostate, glaucoma, or an overactive thyroid.
• 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.
• Children may be more sensitive to this medicine than adults, especially if too much medicine is taken. Always read medicine labels closely and give your child the right amount.

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 or irregular heartbeat
• Severe headache
• Trouble breathing

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

• Drowsiness
• Dry mouth, nose, or throat
• Thickened mucus
• Stomach upset
• Headache
• Restlessness

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