Diphenhydramine Citrate, Ibuprofen Oral tablet

What is this medicine?

DIPHENHYDRAMINE; IBUPROFEN (dye fen HYE dra meen; eye BYOO proe fen) is a combination of a sleep-aid and a non-steroidal anti-inflammatory drug (NSAID). It is used to treat occasional sleeplessness with minor aches and pains.

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

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• asthma
• drink more than 3 alcohol containing drinks a day
• glaucoma
• heart disease
• high blood pressure
• kidney disease
• liver disease
• not drinking fluids
• pain or difficulty passing urine
• prostate trouble
• sore throat with high fever, headache, nausea or vomiting
• stomach bleeding or ulcers
• an unusual or allergic reaction to ibuprofen, aspirin, other NSAIDs, diphenhydramine, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take this medicine with food if your stomach gets upset. Try to not lie down for at least 10 minutes after you take the medicine. Take your medicine at regular intervals. Do not take your medicine 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 of age for selected conditions, precautions do apply.

Patients over 60 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 medicine?

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

• cidofovir
• ketorolac
• methotrexate
• pemetrexed

This medicine may also interact with the following medications:

• alcohol
• alendronate
• aspirin and aspirin-like medicines
• celecoxib
• flavocoxid
• ginkgo
• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate
• medicines for cold, cough or allergy
• medicines for sleep
• other NSAIDS, medicines for pain and inflammation, like ibuprofen or naproxen
• steroid medicines like prednisone or cortisone
• warfarin

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 medicine?

Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse.

This medicine does not prevent heart attack or stroke. In fact, this medicine may increase the chance of a heart attack or stroke. The chance may increase with longer use of this medicine and in people who have heart disease. If you take aspirin to prevent heart attack or stroke, talk with your doctor or health care professional.

Do not take medicines such as ibuprofen and naproxen with this medicine. Side effects such as stomach upset, nausea, or ulcers may be more likely to occur. Many medicines available without a prescription should not be taken with this medicine.

This medicine can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding can happen without warning symptoms and can cause death. To reduce your risk, do not smoke cigarettes or drink alcohol while you are taking 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 or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells.

This medicine can cause you to bleed more easily. Try to avoid damage to your teeth and gums when you brush or floss your teeth.

What side effects may I notice from receiving this medicine?

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

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• black or bloody stool
• breathing problems
• changes in vision
• chest pain
• confused, agitated, nervous
• fast, irregular heartbeat
• general ill feeling or flu-like symptoms
• nausea or vomiting
• redness, blistering, peeling or loosening of the skin, including inside the mouth
• slurred speech or weakness on one side of the body
• stomach pain
• unexplained weight gain or swelling
• unusual bleeding or bruising
• unusually weak or tired
• yellowing of eyes or skin

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

• constipation or diarrhea
• dizziness
• gas or heartburn
• headache
• loss of appetite
• stomach upset
• thick mucous

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 medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Keep container tightly closed. Throw away any unused medicine after the expiration date.

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.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.