Advil PM

Name: Advil PM

What should I avoid while taking Advil PM (diphenhydramine and ibuprofen)?

This medicine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid drinking alcohol. It may increase your risk of stomach bleeding.

Avoid taking aspirin or other NSAIDs while you are taking diphenhydramine and ibuprofen.

Avoid taking ibuprofen if you are taking aspirin to prevent stroke or heart attack. Ibuprofen can make aspirin less effective in protecting your heart and blood vessels.

Ask a doctor or pharmacist before using any cold, cough, allergy, or other sleep medicine. Antihistamines and NSAIDs are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains an antihistamine or ibuprofen (or similar NSAIDs such as aspirin, naproxen, ketoprofen, and others).

Advil PM (diphenhydramine and ibuprofen) side effects

Get emergency medical help if you have signs of an allergic reaction: sneezing, runny or stuffy nose; wheezing or trouble breathing; hives; swelling of your face, lips, tongue, or throat.

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, leg swelling, feeling short of breath.

Stop using this medicine and call your doctor at once if you have:

  • the first sign of any skin rash, no matter how mild;

  • a light-headed feeling, like you might pass out;

  • signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

  • liver problems--nausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  • kidney problems--little or no urinating, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath; or

  • severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

  • drowsiness;

  • day-time drowsiness, dizziness, "hangover" feeling;

  • upset stomach, mild heartburn, diarrhea, constipation;

  • dry mouth, nose, or throat;

  • blurred vision;

  • mild itching or rash; or

  • ringing in your ears.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What are some things I need to know or do while I take Advil PM?

  • Tell all of your health care providers that you take Advil PM. This includes your doctors, nurses, pharmacists, and dentists.
  • Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.
  • Do not take this medicine for longer than you were told by your doctor.
  • Avoid driving and doing other tasks or actions that call for alertness while you take Advil PM. Talk with your doctor.
  • Avoid drinking alcohol while taking this medicine.
  • Talk with your doctor before you use other drugs and natural products that slow your actions.
  • Do not use with other products that have diphenhydramine.
  • This medicine may raise the chance of heart and blood vessel side effects like heart attack and stroke. If these happen, they can be deadly. The risk of these side effects may be greater if you have heart disease or risks for heart disease. However, the risk may also be raised in people who do not have heart disease or risks for heart disease. The risk of these health problems can happen as soon as the first weeks of using Advil PM and may be greater with higher doses or with long-term use. Do not use this medicine right before or after bypass heart surgery.
  • This medicine may raise the chance of very bad and sometimes deadly stomach or bowel side effects like ulcers or bleeding. The risk is greater in older people. The risk is also greater in people who have had stomach or bowel ulcers or bleeding before. These problems may occur without warning signs. Talk with the doctor.
  • You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
  • The chance of heart failure is raised with the use of drugs like this one. In people who already have heart failure, the chance of heart attack, having to go to the hospital for heart failure, and death is raised. Talk with the doctor.
  • The chance of heart attack and heart-related death is raised in people taking drugs like this one after a recent heart attack. People taking drugs like this one after a first heart attack were also more likely to die in the year after the heart attack compared with people not taking drugs like this one. Talk with the doctor.
  • If you are taking aspirin to help prevent a heart attack, talk with your doctor.
  • Use with care in children. Talk with the doctor.
  • If you are 60 or older, use Advil PM (diphenhydramine and ibuprofen) with care. You could have more side effects.
  • This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking this medicine, call your doctor right away.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Warnings

Allergy alert:

Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock
  • skin reddening
  • rash
  • blisters

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning:

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed

Do not use

  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • unless you have time for a full night's sleep
  • in children under 12 years of age
  • right before or after heart surgery
  • with any other product containing diphenhydramine, even one used on skin
  • if you have sleeplessness without pain

Ask a doctor before use if

  • stomach bleeding warning applies to you
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma
  • you are taking a diuretic
  • you have a breathing problem such as emphysema or chronic bronchitis
  • you have glaucoma
  • you have trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

  • taking sedatives or tranquilizers, or any other sleep-aid
  • under a doctor’s care for any continuing medical illness
  • taking any other antihistamines
  • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • taking any other drug

When using this product

  • drowsiness will occur
  • avoid alcoholic drinks
  • do not drive a motor vehicle or operate machinery
  • take with food or milk if stomach upset occurs
  • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stop use and ask a doctor if

  • you experience any of the following signs of stomach bleeding:
    • feel faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better
  • pain gets worse or lasts more than 10 days
  • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
  • redness or swelling is present in the painful area
  • any new symptoms appear

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of the reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Usual Pediatric Dose for Insomnia

DiphenhydrAMINE-ibuprofen 38 mg-200 mg oral tablet:
12 yrs or older: 2 tablets orally at bedtime not to exceed 2 tablets daily.

DiphenhydrAMINE-ibuprofen 25 mg-200 mg oral capsule:
12 yrs or older: 2 capsules orally at bedtime not to exceed 2 capsules daily.

Renal Dose Adjustments

Data not available

Diphenhydramine / ibuprofen Breastfeeding Warnings

Diphenhydramine is excreted into human milk. Diphenhydramine may also inhibit lactation. Ibuprofen has not been detected in human milk. Ibuprofen is considered compatible with breast-feeding by the American Academy of Pediatrics. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

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