Advil PM

Name: Advil PM

Advil PM Overview

Advil PM is an over the counter medication used to treat headaches, minor aches and pain, and difficulty sleeping due to minor pain.

It is a single product containing 2 ingredients: ibuprofen and diphenhydramine. Ibuprofen belongs to a group of drugs called non-steroidal anti-inflammatory drugs (NSAIDs), which work by providing pain/headache relief. Diphenhydramine belongs to a group of drugs called Histamine H1 Antagonists (antihistamine). It works by blocking the action of histamine and allergy symptoms, but is also known to cause sleepiness and drowsiness. 

This medication comes in a caplet form, and is usually taken at bedtime with food or a small snack.

Common side effects of Advil PM includes stomach upset and dizziness. Advil PM can also cause drowsiness. Do not drive or operate heavy machinery until you know how Advil PM affects you. 

What should I discuss with my healthcare provider before taking Advil PM (diphenhydramine and ibuprofen)?

Ibuprofen can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Even people without heart disease or risk factors could have a stroke or heart attack while taking this medicine.

Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Ibuprofen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using ibuprofen, especially in older adults.

You should not use this medicine if you are allergic to diphenhydramine or ibuprofen, or if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID.

Ask a doctor or pharmacist if it is safe for you to use this medicine if you have other medical conditions, especially:

  • heart disease, high blood pressure;

  • a history of heart attack, stroke, or blood clot;

  • a history of stomach ulcers or bleeding;

  • a breathing problem, such as asthma, emphysema, or bronchitis;

  • liver or kidney disease;

  • glaucoma;

  • enlarged prostate or problems with urination; or

  • if you drink 3 or more alcoholic beverages per day.

This medicine may be harmful to an unborn baby. Taking ibuprofen during the last 3 months of pregnancy may result in birth defects and prolonged labor and delivery. Do not use this medicine without a doctor's advice if you are pregnant.

Diphenhydramine and ibuprofen may pass into breast milk and may harm a nursing baby. Antihistamines may also slow breast milk production. Do not use this medicine without a doctor's advice if you are breast-feeding a baby.

This medicine is not approved for use by anyone younger than 12 years old. Always ask a doctor before giving an antihistamine to a child. Death can occur from the misuse of antihistamines in very young children.

Uses of Advil PM

  • It is used to help you fall asleep and stay asleep when you are not able to sleep because of minor aches and pains.

Active ingredients (in each caplet)

Diphenhydramine citrate 38 mg

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Product packaging

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

Advil PM

Ibuprofen, 200 mg / Diphenhydramine citrate, 38 mg

Pain Reliever (NSAID) / Nighttime Sleep-Aid

40 Coated Caplets*

*Capsule-Shaped Tablets

See new warnings information

READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION.

Do Not Use if seal under bottle cap imprinted with “SEALED for YOUR PROTECTION” is broken or missing.

Wyeth

For most recent product information, visit www.Advil.com.

Wyeth Consumer Healthcare, Madison, NJ 07940 USA ©2009 Wyeth

Appearance of the blue Advil PM caplet is a trademark of Wyeth Consumer Healthcare

U.S. Patent Pending

Advil PM 
diphenhydramine citrate, ibuprofen tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0164
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
diphenhydramine citrate (diphenhydramine ) diphenhydramine citrate 38 mg
ibuprofen (ibuprofen) ibuprofen 200 mg
Product Characteristics
Color BLUE (blue) Score no score
Shape CAPSULE Size 15mm
Flavor Imprint Code Advil;PM
Contains     
Packaging
# Item Code Package Description
1 NDC:0573-0164-33 1 BOTTLE (BOTTLE) in 1 CARTON
1 50 TABLET, COATED (TABLET) in 1 BOTTLE
2 NDC:0573-0164-04 4 TABLET, COATED (TABLET) in 1 POUCH
3 NDC:0573-0164-20 1 BOTTLE (BOTTLE) in 1 CARTON
3 20 TABLET, COATED (TABLET) in 1 BOTTLE
4 NDC:0573-0164-30 1 BOTTLE (BOTTLE) in 1 CARTON
4 40 TABLET, COATED (TABLET) in 1 BOTTLE
5 NDC:0573-0164-40 1 BOTTLE (BOTTLE) in 1 CARTON
5 80 TABLET, COATED (TABLET) in 1 BOTTLE
6 NDC:0573-0164-43 1 BOTTLE (BOTTLE) in 1 CARTON
6 120 TABLET, COATED (TABLET) in 1 BOTTLE
7 NDC:0573-0164-45 1 BOTTLE (BOTTLE) in 1 CARTON
7 180 TABLET, COATED (TABLET) in 1 BOTTLE
8 NDC:0573-0164-32 1 BOTTLE (BOTTLE) in 1 CARTON
8 50 TABLET, COATED (TABLET) in 1 BOTTLE
9 NDC:0573-0164-41 1 BOTTLE (BOTTLE) in 1 CARTON
9 100 TABLET, COATED (TABLET) in 1 BOTTLE
10 NDC:0573-0164-91 3000 POUCH (POUCH) in 1 BOX
10 2 TABLET, COATED (TABLET) in 1 POUCH
11 NDC:0573-0164-05 2 BOTTLE (POUCH) in 1 CARTON
11 2 TABLET, COATED (TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021394 12/21/2005
Labeler - Pfizer Consumer Healthcare (828831730)
Establishment
Name Address ID/FEI Operations
Wyeth Pharmaceuticals Company, Consumer Site 829390975 MANUFACTURE, ANALYSIS
Revised: 06/2010   Pfizer Consumer Healthcare

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Chest pain or pressure.
  • Shortness of breath, a big weight gain, or swelling in the arms or legs.
  • Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
  • Very bad dizziness or passing out.
  • Any unexplained bruising or bleeding.
  • Very bad belly pain.
  • Black, tarry, or bloody stools.
  • Throwing up blood or throw up that looks like coffee grounds.

For Healthcare Professionals

Applies to diphenhydramine / ibuprofen: oral capsule, oral tablet

Nervous system

The CNS depressant effect of diphenhydramine parallels its plasma concentrations. The plasma concentration threshold for sedation is 30 to 42 ng/mL, and to cause mental impairment is 58 to 74 ng/mL. Dystonic reactions have been accompanied by dizziness, mental confusion, rigidity, lip and tongue protrusion, trismus, torticollis, and swallowing difficulties and generally resolve spontaneously. Toxic encephalopathy has been reported in a child with chicken pox treated generously with topical diphenhydramine. Delirium has been reported in elderly patients with mild dementia following a small oral dose of diphenhydramine.

The incidence of aseptic meningitis associated with ibuprofen is higher in patients with systemic lupus erythematosus and other connective tissue disease, although it has been reported in patients without such underlying disease states.[Ref]

Nervous system side effects of diphenhydramine have frequently included depression with drowsiness and sedation in nearly all patients treated. Motor skills may be impaired. Dystonic reactions have been reported after single doses of diphenhydramine.

Nervous system side effects of ibuprofen have rarely incuded headache, drowsiness, and dizziness. Aseptic meningitis, paresthesias, and pseudotumor cerebri have rarely been associated with the use of ibuprofen. Other nervous system side effects of ibuprofen have included tinnitus (1% to 3%) and vertigo.[Ref]

Cardiovascular

A rare case of painful, persistent peripheral cyanosis and swelling of the fingers and toes which progressed to desquamation and digital pitting infarctions has been associated with ibuprofen.[Ref]

Cardiovascular side effects of diphenhydramine have included hypotension, tachycardia, and palpitations.

Cardiovascular side effects of ibuprofen include peripheral edema (1% to 3%) and elevated blood pressure (less than 1%). These problems may be important in some patients with preexisting hypertension or congestive heart failure.[Ref]

Gastrointestinal

Gastrointestinal side effects of diphenhydramine have been usually mild and included nausea and dry mouth.

Gastrointestinal side effects of ibuprofen have included dyspepsia, nausea, diarrhea, abdominal pain, and flatulence.[Ref]

More serious gastrointestinal effects of ibuprofen are uncommon but include occult blood loss, ulcer, gastrointestinal hemorrhage with or without perforation, and pancreatitis. In addition, a case of ibuprofen-associated colitis has been reported.

The incidence of gastrointestinal blood loss with ibuprofen is dose-related, occurring in up to 17% of patients receiving 1,600 mg per day and in 23% of patients receiving 2,400 mg per day.

Patients with a history of serious gastrointestinal events or alcohol abuse are at increased risk for severe gastrointestinal side effect. Ibuprofen should be used with caution in these patients.[Ref]

Genitourinary

Genitourinary side effects of diphenhydramine have included urinary retention and dysuria as a result of the anticholinergic effects of diphenhydramine.[Ref]

Hematologic

Reductions in serum hemoglobin concentrations are uncommon and are usually associated with occult gastrointestinal blood loss. Rare cases of ibuprofen-associated hemolytic anemia, autoimmune thrombocytopenia, and leukopenia have been reported.[Ref]

Hematologic side effects of diphenhydramine have rarely included hemolytic anemia, thrombocytopenia, and agranulocytosis.

Hematologic side effects of ibuprofen have included platelet dysfunction, neutropenia, agranulocytosis, aplastic anemia, hemolytic anemia, thrombocytopenia, eosinophilia, and decreases in hemoglobin and hematocrit.[Ref]

Hypersensitivity

Most commonly, hypersensitivity to diphenhydramine has manifested itself in patients receiving systemic drug after being sensitized to it by topical application. Sensitization with systemic administration has also been reported.[Ref]

Hypersensitivity side effects of diphenhydramine have included rash, pruritus, and eczema. Photosensitivity reactions have also been reported.

Hypersensitivity side effects of ibuprofen have included erythematous or urticarial rashes, pruritus, angioedema, bronchospasm, and anaphylactoid reactions. Patients who are at higher risk of hypersensitivity reactions to ibuprofen include those with the syndrome of asthma, nasal polyps, and angioedema and/or bronchospastic reactivity to aspirin. Rare cases of systemic reactions, including interstitial nephritis and diffuse pulmonary infiltrates, have also been reported.[Ref]

Ocular

Ocular side effects of diphenhydramine have included blurred vision, diplopia, and dry eyes due to anticholinergic effects.

Ocular side effects of ibuprofen have included blurred vision (less than 1%), scotomata, and diplopia.[Ref]

Dermatologic

Dermatologic side effects of ibuprofen have included maculopapular rash, pruritus, vesiculobullous eruptions, erythema multiforme, Stevens-Johnson syndrome, alopecia, toxic epidermal necrolysis, and photosensitivity reactions.[Ref]

Hepatic

Hepatic side effects of ibuprofen have included elevations in liver function tests in up to 15% of patients. Jaundice and hepatitis have rarely been reported.[Ref]

Elevations in liver function tests three times normal values occur in less than 1% of patients treated with ibuprofen. Ibuprofen-induced hepatitis has been associated with a fatal outcome in some cases.[Ref]

Metabolic

Metabolic side effects of ibuprofen have included hyponatremia and the Syndrome of Inappropriate Antidiuretic Hormone (SIADH), gynecomastia, hypoglycemia, and metabolic acidosis.[Ref]

Renal

Renal side effects of ibuprofen have included new or worsened renal insufficiency. Patients at higher risk of developing renal insufficiency during therapy include the elderly, patients with preexisting renal insufficiency, and any patients with a history of heart failure or renal artery stenosis. Rarer renal side effects associated with the use of ibuprofen include the nephrotic syndrome with and without renal failure and acute renal failure due to tubulointerstitial nephritis, papillary necrosis, and acute tubular necrosis.[Ref]

Ibuprofen may impair the ability of the kidney to cope with low renal blood flow states due to inhibition of prostaglandin-dependent afferent arteriolar vasodilation. Renal function may be further compromised in patients with heart failure, hypovolemia, cirrhosis, nephrotic syndrome, or hypoalbuminemia. Additional risk factors for ibuprofen-induced renal insufficiency are advanced age and concomitant use of diuretics.

A case-controlled study suggested that patients who consumed 5000 or more pills containing NSAIDs during their lifetime may be at increased risk of end-stage renal disease.[Ref]

Respiratory

Respiratory side effects of ibuprofen have included noncardiogenic pulmonary edema.[Ref]

Acute noncardiogenic pulmonary edema developed on two occasions in an HIV-positive patient. Infectious as well as cardiac etiologies were excluded. A close temporal relationship with the administration of ibuprofen and onset of symptoms was noted.[Ref]

Some side effects of Advil PM may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Precautions

Patients should be advised that when using this product the risk of heart attack or stroke may increase if they use more than directed or for longer than directed.

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