Ibuprofen; Pseudoephedrine tablets or caplets

What is this medication?

IBUPROFEN; PSEUDOEPHEDRINE (eye BYOO proe fen; soo doe e FED rin) is a combination of a non-steroidal anti-inflammatory drug (NSAID) and a decongestant. It is used to treat the aches and pains, congestion, and fever of the common cold, flu, or sinus problems.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Advil Cold and Sinus, Advil Flu and Body Ache, Dristan Sinus, Motrin Cold and Sinus, Motrin Sinus Headache

What should I tell my care team before I take this medication?

They need to know if you have any of the following conditions:

• bleeding problems
• diabetes
• heart disease or surgery
• high blood pressure
• kidney disease
• not drinking fluids
• severe vomiting or diarrhea
• stomach ulcer or other problems
• taken an MAOI like Carbex, Eldepryl, Marplan, Nardil, or Parnate in last 14 days
• thyroid disease
• an unusual or allergic reaction to ibuprofen, pseudoephedrine, other fever reducers or pain relievers, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with a glass of water. Follow the directions on the package label. You can take it with or without food. If it upsets your stomach, take it with food. Try to not lie down for at least 10 minutes after you take the medicine. Take your medicine at regular intervals. Do not take it more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 12 years old for selected conditions, precautions do apply.

Patients over 65 years old may have a stronger reaction and need a smaller dose.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medicine with any of the following medications:

•bromocriptine

•cidofovir

•cocaine

•ergot alkaloids like dihydroergotamine, ergonovine, ergotamine, methylergonovine

•MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate

•methotrexate

•pemetrexed

•stimulant medicines for attention disorders, weight loss, or to stay awake

This medicine may also interact with the following medications:

•alcohol

•alendronate

•aspirin and aspirin-like medicines

•cyclopropane

•furazolidone

•linezolid

•ginkgo

•mecamylamine

•medicines for bladder problems

•medicines for blood pressure, heart disease, irregular heart beat

•medicines for chest pain like digoxin, nifedipine, verapamil

•medicines for depression, anxiety, or psychotic disturbances

•medicine for prostate

•medicines for sleep during surgery

•medicines that treat or prevent blood clots like warfarin, enoxaparin, and dalteparin

•other drugs for congestion, fever, inflammation, or pain

•procarbazine

•reserpine

•steroid medicines like prednisone or cortisone

•St. John's Wort

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Tell your doctor or health care provider if your symptoms do not start to get better or if they get worse. See your doctor if fever, pain, or nasal congestion gets worse or lasts more than 3 days.

If this medicine makes it hard for you to sleep, try taking the dose earlier in the day. If you still have trouble sleeping stop taking this medicine and see your doctor.

Do not take other medicines that contain aspirin, ibuprofen, or naproxen with this medicine. Side effects such as stomach upset, nausea, or ulcers may be more likely to occur. Many non-prescription medicines contain aspirin, ibuprofen, or naproxen. Always read labels carefully.

This medicine can cause serious ulcers and bleeding in the stomach. It can happen with no warning. Smoking, drinking alcohol, older age, and poor health can also increase risks. Call your health care provider right away if you have stomach pain or blood in your vomit or stool.

This medicine does not prevent a heart attack or stroke. This medicine may increase the chance of a heart attack or stroke. The chance may increase the longer you use this medicine or if you have heart disease. If you take aspirin to prevent a heart attack or stroke, talk to your health care provider about using this medicine.

Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

This medicine may cause serious skin reactions. They can happen weeks to months after starting the medicine. Contact your health care provider right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. Or, you might notice a red rash with swelling of the face, lips or lymph nodes in your neck or under your arms.

Talk to your health care provider if you are pregnant before taking this medicine. Taking this medicine between weeks 20 and 30 of pregnancy may harm your unborn baby. Your health care provider will monitor you closely if you need to take it. After 30 weeks of pregnancy, do not take this medicine.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand up or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells.

Be careful brushing or flossing your teeth or using a toothpick because you may get an infection or bleed more easily. If you have any dental work done, tell your dentist you are receiving this medicine.

This medicine may make it more difficult to get pregnant. Talk to your health care provider if you are concerned about your fertility.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions (skin rash, itching or hives; swelling of the face, lips, or tongue)
• aseptic meningitis (stiff neck; sensitivity to light; headache; drowsiness; fever; nausea, vomiting; rash)
• bleeding (bloody or black, tarry stools; red or dark brown urine; spitting up blood or brown material that looks like coffee grounds; red spots on the skin; unusual bruising or bleeding from the eyes, gums, or nose)
• blurred vision OR changes in vision
• fast, irregular heartbeat
• heart attack (trouble breathing; pain or tightness in the chest, neck, back or arms; unusually weak or tired)
• heart failure (trouble breathing; fast, irregular heartbeat; sudden weight gain; swelling of the ankles, feet, hands; unusually weak or tired)
• high potassium levels (chest pain; fast, irregular heartbeat; muscle weakness)
• increase in blood pressure
• infection (fever, chills, cough, sore throat, pain or trouble passing urine)
• kidney injury (trouble passing urine or change in the amount of urine)
• liver injury (dark yellow or brown urine; general ill feeling or flu-like symptoms; loss of appetite, right upper belly pain; unusually weak or tired, yellowing of the eyes or skin)
• low blood pressure (dizziness; feeling faint or lightheaded, falls; unusually weak or tired)
• low red blood cell counts (trouble breathing; feeling faint; lightheaded, falls; unusually weak or tired)
• rash, fever, and swollen lymph nodes
• redness, blistering, peeling, or loosening of the skin, including inside the mouth
• stroke (changes in vision; confusion; trouble speaking or understanding; severe headaches; sudden numbness or weakness of the face, arm or leg; trouble walking; dizziness; loss of balance or coordination)

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• anxious
• bruising
• constipation
• diarrhea
• headache
• loss of appetite
• nausea, vomiting
• trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

This medicine may cause accidental overdose and death if taken by other adults, children, or pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F).

Get rid of any unused medicine after the expiration date.

To get rid of medicines that are no longer needed or have expired:

• Take the medicine to a medicine take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medicine, check the label or package insert to see if the medicine should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your health care provider. If it is safe to put it in the trash, empty the medicine out of the container. Mix the medicine with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.