Advil

Name: Advil

What Is Ibuprofen (Advil)?

Ibuprofen, sold under the brand names Advil, Motrin, and Ibuprin, is a medication used to relieve pain, swelling and inflammation.

Motrin and Advil can be purchased over-the-counter in 200 milligram (mg) tablets, while higher doses require a prescription.

Available in tablets and capsules, ibuprofen is also found in combination with other drugs sold over-the-counter (OTC) for cough, cold, and migraine.

In certain situations, ibuprofen may be given in hospitals in liquid form through the veins, or intravenously (IV).

Ibuprofen belongs to group of drugs known as non-steroidal anti-inflammatory drugs, or NSAIDs, which work by inhibiting prostaglandins, chemicals that can cause inflammation in the body.

The Food and Drug Administration (FDA) originally approved ibuprofen under the Motrin brand in 1974. It was manufactured by McNeil.

Ibuprofen versus Tylenol (Acetaminophen)

Tylenol (acetaminophen) provides pain relief but, unlike NSAIDs such as ibuprofen, it has no effect on inflammation.

This is because Tylenol works differently than ibuprofen and NSAIDs. To date, the way Tylenol works is not fully clear, but it's thought to reduce pain by acting on pain receptors in the brain.

Unlike ibuprofen, Tylenol has no activity in the stomach and does not cause problems with stomach pain or acid reflux.

And like most NSAIDs including ibuprofen, Tylenol reduces fever.

Ibuprofen versus Aleve (Naproxen)

Ibuprofen and Aleve (naproxen) are similar in that they contain the same basic chemical building block.

In addition, they are both available over-the-counter in low doses and via prescription in higher doses.

However, the effects of ibuprofen do not tend to last as long as Aleve, so you may have to take it every four to six hours (up to six times a day).

Aleve only has to be taken up to three times a day, or every eight hours.

Ibuprofen Warnings

Ibuprofen has two black-box warnings:

  1. Ibuprofen can increase the risk of heart trouble and has been linked to heart attacks, strokes, and blood clots, all of which can be deadly.
  2. Ibuprofen can damage the lining of your stomach, putting you at risk for stomach ulcers and heartburn.

If you are allergic to ibuprofen or any of its inactive ingredients, you should not take Ibuprofen.

People who are about to undergo heart surgery, especially a procedure called coronary artery bypass graft (CABG), should not take ibuprofen.

You should also be careful taking ibuprofen and first speak to your doctor if any of the following apply to you:

  • Have ever had asthma or strong allergic reaction such as hives caused by a reaction to taking aspirin or other NSAIDs
  • Congestive heart failure
  • Extremely low count of red blood cells (severe anemia)
  • Increased pressure in the skull (increased intracranial pressure, or ICP)
  • Recent heart attack
  • Smoke
  • Are a heavy drinker
  • Systemic lupus erythematous (SLE)
  • Any bleeding disorders, including slow or poor clotting, blood cell abnormalities

Ibuprofen and the Elderly

Older persons should be careful taking ibuprofen.

The side effects caused by NSAID pain medications such as ibuprofen, when taken by elderly patients, can put them at risk for falls and other dangerous consequences.

In general, NSAIDs that are available over-the-counter and via prescription can cause extreme sleepiness, confusion, dizziness, loss of balance, and severe stomach problems in the elderly.

However, low doses of ibuprofen tend to be a safer choice for elderly patients than most other painkillers. To be on the safe side, talk to you doctor or pharmacist about your concerns.

Ibuprofen for Dogs

Ibuprofen is not safe to give to a dog.

Talk to your veterinarian about other painkillers that are safe for your dog, because ibuprofen (and other pain medications) can cause severe or life-threatening digestive, kidney, or liver problems.

However, some painkillers can safely relieve pain and swelling in dogs just as they do in humans, and generally do not cause any unwanted side effects.

Pain medications that are safe for dogs include:

  • Etogesic (etodolac)
  • Previcox (firocoxib)
  • Metacam (meloxicam)
  • Novox, Rimadyl (carprofen)
  • Deramaxx (deracoxib)
  • Previcox (firocoxib)
  • Zubrin (tepoxalin)

Pregnancy and Ibuprofen

Because the risk of harm to an unborn child varies during pregnancy, ibuprofen falls under two pregnancy categories:

For the first 29 weeks of pregnancy, ibuprofen carries some risk of harm to the fetus.

For women who are 30 weeks and beyond, ibuprofen should only be taken in situations when there are no safer options available.

Ibuprofen can cause a birth defect by causing a major artery that nourishes the baby's heart to close too soon.

Ibuprofen is also found in breast milk, and mothers should avoid taking this drug while breastfeeding.

Regardless, you should tell your doctor if you are pregnant or plan to become pregnant before taking this medication.

You should also alert your physician if you are breastfeeding or plan to breastfeed.

Advil Overview

Ibuprofen is both an over-the-counter and a prescription medication. The over-the-counter form is used both to treat minor aches and pains and also to reduce fever. The prescription form is used for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis, mild to moderate pain, and to treat primary dysmenorrhea. It may also be used to reduce fever in adults. This medication page refers to the prescription form of ibuprofen.

This medication comes in tablet and oral suspension forms. Ibuprofen may be given up to 6 times per day with food or milk to avoid stomach irritation.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Common side effects of ibuprofen include nausea, heartburn, diarrhea, stomach irritation, or headache. Ibuprofen can also cause dizziness. Do not drive or operate heavy machinery until you know how this medication will affect you.

Side Effects of Advil

Serious side effects have been reported with ibuprofen. See “Drug Precautions” section.

Common side effects of ibuprofen include:

  • stomach effects:  nausea, heartburn, diarrhea, stomach irritation, bloating or flatulence, constipation
  • others: headache, dizziness, ringing in the ears, swelling of arms or legs, rash

This is not a complete list of ibuprofen side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I avoid while taking ibuprofen?

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

Avoid taking aspirin while you are taking 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. If you must use both medications, take the ibuprofen at least 8 hours before or 30 minutes after you take the aspirin (non-enteric coated form).

Ask a doctor or pharmacist before using any cold, allergy, or pain medicine. Many medicines available over the counter contain aspirin or other medicines similar to ibuprofen. Taking certain products together can cause you to get too much of this type of medication. Check the label to see if a medicine contains aspirin, ibuprofen, ketoprofen, or naproxen.

Advil Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
  • Abdominal pain
  • acid or sour stomach
  • belching
  • bloating
  • cloudy urine
  • decrease in amount of urine
  • decrease in urine output or decrease in urine-concentrating ability
  • diarrhea
  • difficulty having a bowel movement (stool)
  • excess air or gas in stomach or intestines
  • full feeling
  • heartburn
  • indigestion
  • itching skin
  • pain or discomfort in chest, upper stomach, or throat
  • pale skin
  • passing gas
  • nausea
  • noisy, rattling breathing
  • rash with flat lesions or small raised lesions on the skin
  • shortness of breath
  • swelling of face, fingers, hands, feet, lower legs, or ankles
  • troubled breathing at rest
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vomiting
  • weight gain
Less common
  • Abdominal cramps
  • stomach soreness or discomfort
Rare
  • Agitation
  • back, leg, or stomach pains
  • bleeding gums
  • blistering, peeling, loosening of skin
  • blood in urine or stools
  • bloody, black, or tarry stools
  • blurred vision
  • burning feeling in chest or stomach
  • change in vision
  • chest pain
  • chills
  • clay-colored stools
  • coma
  • confusion
  • constipation
  • cough or hoarseness
  • dark urine
  • decreased urine output
  • depression
  • difficulty breathing
  • difficulty swallowing
  • dilated neck veins
  • dizziness
  • dry mouth
  • extreme fatigue
  • fast, irregular, pounding, or racing heartbeat or pulse
  • fever with or without chills
  • frequent urination
  • general body swelling
  • general feeling of tiredness or weakness
  • hair loss, thinning of hair
  • headache
  • hives or welts
  • hostility
  • impaired vision
  • increased blood pressure
  • increased volume of pale, dilute urine
  • irregular breathing
  • irritability
  • itching
  • joint or muscle pain
  • lab results that show problems with liver
  • lethargy
  • light-colored stools
  • loss of appetite
  • lower back or side pain
  • muscle twitching
  • nosebleeds
  • painful or difficult urination
  • pains in stomach, side, or abdomen, possibly radiating to the back
  • pinpoint red spots on skin
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • rash
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • redness of skin
  • seizures
  • severe abdominal pain, cramping, burning
  • severe and continuing nausea
  • sore throat
  • sores, ulcers, or white spots in mouth or on lips
  • stiff neck or back
  • stomach upset
  • stupor
  • swollen or painful glands
  • tenderness in stomach area
  • thirst
  • tightness in chest
  • unpleasant breath odor
  • upper right abdominal pain
  • vomiting of blood
  • vomiting of material that looks like coffee grounds
  • wheezing
  • yellow eyes and skin
Symptoms of overdose
  • Bluish lips or skin
  • difficulty sleeping
  • disorientation
  • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
  • drowsiness to profound coma
  • hallucination
  • lightheadedness or fainting
  • mood or other mental changes
  • muscle tremors
  • not breathing
  • rapid, deep breathing
  • restlessness
  • slow or irregular heartbeat
  • stomach cramps
  • sudden fainting
  • sweating

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Continuing ringing or buzzing or other unexplained noise in ears
  • hearing loss
  • nervousness
Rare
  • Crying
  • depersonalization
  • discouragement
  • dry eyes
  • dysphoria
  • euphoria
  • feeling sad or empty
  • lack of appetite
  • loss of interest or pleasure
  • mental depression
  • paranoia
  • quick to react or overreact
  • rapidly changing moods
  • runny nose
  • sleepiness or unusual drowsiness
  • sleeplessness
  • sneezing
  • stuffy nose
  • trouble concentrating
  • trouble sleeping
  • unable to sleep

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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 non-prescription 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
  • right before or after heart surgery

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

Ask a doctor or pharmacist before use if you are

  • under a doctor’s care for any serious condition
  • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • taking any other drug

When using this product

  • 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
  • fever gets worse or lasts more than 3 days
  • 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 reach of children.

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

Inactive ingredients

Advil Tablets

acetylated monoglycerides, colloidal silicon dioxide, corn starch, croscarmellose sodium, methylparaben, microcrystalline cellulose, pharmaceutical glaze, pharmaceutical ink, povidone, pregelatinized starch, propylparaben, sodium benzoate, sodium lauryl sulfate, stearic acid, sucrose, synthetic iron oxide, titanium dioxide, white wax

Advil Caplets

acetylated monoglycerides, colloidal silicon dioxide, corn starch, croscarmellose sodium, methylparaben, microcrystalline cellulose, pharmaceutical glaze, pharmaceutical ink, povidone, pregelatinized starch, propylparaben, sodium benzoate, sodium lauryl sulfate, stearic acid, sucrose, synthetic iron oxide, titanium dioxide, white wax

Advil Gel Caplets

colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C red no. 40, FD&C yellow no. 6, fractionated coconut oil, gelatin, glycerin, hypromellose, pharmaceutical ink, pregelatinized starch, propyl gallate, purified water, sodium lauryl sulfate, stearic acid, synthetic iron oxides, titanium dioxide, triacetin

Questions or comments?

call toll-free 1-800-88-Advil

Product packaging

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

Advil

Ibuprofen Tablets, 200 mg

Pain Reliever / Fever Reducer (NSAID)

100 Coated 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 U.S. Patent No. 5,087,454

Appearance of the brown Advil tablet is a trademark of Wyeth Consumer Healthcare

Advil 
ibuprofen tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0150
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Ibuprofen (Ibuprofen) Ibuprofen 200 mg
Product Characteristics
Color BROWN (pinkish brown) Score no score
Shape ROUND (smooth in texture with polish surface) Size 10mm
Flavor Imprint Code Advil
Contains     
Packaging
# Item Code Package Description
1 NDC:0573-0150-20 1 BOTTLE (BOTTLE) in 1 CARTON
1 20 TABLET, COATED (TABLET) in 1 BOTTLE
2 NDC:0573-0150-30 1 BOTTLE (BOTTLE) in 1 CARTON
2 50 TABLET, COATED (TABLET) in 1 BOTTLE
3 NDC:0573-0150-40 1 BOTTLE (BOTTLE) in 1 CARTON
3 100 TABLET, COATED (TABLET) in 1 BOTTLE
4 NDC:0573-0150-31 1 BOTTLE (BOTTLE) in 1 CARTON
4 75 TABLET, COATED (TABLET) in 1 BOTTLE
5 NDC:0573-0150-32 1 BOTTLE (BOTTLE) in 1 CARTON
5 60 TABLET, COATED (TABLET) in 1 BOTTLE
6 NDC:0573-0150-41 1 BOTTLE (BOTTLE) in 1 CARTON
6 125 TABLET, COATED (TABLET) in 1 BOTTLE
7 NDC:0573-0150-42 1 BOTTLE (BOTTLE) in 1 CARTON
7 150 TABLET, COATED (TABLET) in 1 BOTTLE
8 NDC:0573-0150-48 325 TABLET, COATED (TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018989 05/18/1984
Advil 
ibuprofen tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0160
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ibuprofen (ibuprofen) ibuprofen 200 mg
Product Characteristics
Color BROWN (pinkish brown) Score no score
Shape OVAL (smooth in texture polished oval shaped tablet) Size 15mm
Flavor Imprint Code Advil
Contains     
Packaging
# Item Code Package Description
1 NDC:0573-0160-20 1 BOTTLE (BOTTLE) in 1 CARTON
1 24 TABLET, COATED (TABLET) in 1 BOTTLE
2 NDC:0573-0160-30 1 BOTTLE (BOTTLE) in 1 CARTON
2 50 TABLET, COATED (TABLET) in 1 BOTTLE
3 NDC:0573-0160-40 1 BOTTLE (BOTTLE) in 1 CARTON
3 100 TABLET, COATED (TABLET) in 1 BOTTLE
4 NDC:0573-0160-25 1 BOTTLE (BOTTLE) in 1 CARTON
4 36 TABLET, COATED (TABLET) in 1 BOTTLE
5 NDC:0573-0160-31 1 BOTTLE (BOTTLE) in 1 CARTON
5 75 TABLET, COATED (TABLET) in 1 BOTTLE
6 NDC:0573-0160-41 1 BOTTLE (BOTTLE) in 1 CARTON
6 125 TABLET, COATED (TABLET) in 1 BOTTLE
7 NDC:0573-0160-42 1 BOTTLE (BOTTLE) in 1 CARTON
7 150 TABLET, COATED (TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018989 05/18/1984
Advil 
ibuprofen tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0165
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ibuprofen (ibuprofen) ibuprofen 200 mg
Product Characteristics
Color BROWN (one hemisphere is brown while the other hemisphere is yellow) Score no score
Shape CAPSULE (smooth in texture with polished surface) Size 16mm
Flavor Imprint Code Advil
Contains     
Packaging
# Item Code Package Description
1 NDC:0573-0165-20 1 BOTTLE (BOTTLE) in 1 CARTON
1 24 TABLET, COATED (TABLET) in 1 BOTTLE
2 NDC:0573-0165-30 1 BOTTLE (BOTTLE) in 1 CARTON
2 50 TABLET, COATED (TABLET) in 1 BOTTLE
3 NDC:0573-0165-40 1 BOTTLE (BOTTLE) in 1 CARTON
3 100 TABLET, COATED (TABLET) in 1 BOTTLE
4 NDC:0573-0165-41 1 BOTTLE (BOTTLE) in 1 CARTON
4 125 TABLET, COATED (TABLET) in 1 BOTTLE
5 NDC:0573-0165-42 1 BOTTLE (BOTTLE) in 1 CARTON
5 150 TABLET, COATED (TABLET) in 1 BOTTLE
6 NDC:0573-0165-31 1 BOTTLE (BOTTLE) in 1 CARTON
6 75 TABLET, COATED (TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018989 05/18/1984
Advil 
ibuprofen tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0154
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ibuprofen (ibuprofen) ibuprofen 200 mg
Product Characteristics
Color BROWN (pinkish brown) Score no score
Shape ROUND (smooth in texture with polished surface) Size 10mm
Flavor Imprint Code Advil
Contains     
Packaging
# Item Code Package Description
1 NDC:0573-0154-35 1 BOTTLE (BOTTLE) in 1 CARTON
1 150 TABLET, COATED (TABLET) in 1 BOTTLE
2 NDC:0573-0154-75 1 BOTTLE (BOTTLE) in 1 CARTON
2 200 TABLET, COATED (TABLET) in 1 BOTTLE
3 NDC:0573-0154-17 3000 POUCH (POUCH) in 1 CASE
3 2 TABLET, COATED (TABLET) in 1 POUCH
4 NDC:0573-0154-89 50 POUCH (POUCH) in 1 CASE
4 2 TABLET, COATED (TABLET) in 1 POUCH
5 NDC:0573-0154-84 1 BOTTLE (BOTTLE) in 1 CARTON
5 225 TABLET, COATED (TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018989 05/18/1984
Advil 
ibuprofen tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0151
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ibuprofen (ibuprofen) ibuprofen 200 mg
Product Characteristics
Color BROWN (pinkish brown ) Score no score
Shape ROUND (smooth in texture with polished suface) Size 10mm
Flavor Imprint Code Advil
Contains     
Packaging
# Item Code Package Description
1 NDC:0573-0151-12 10 TABLET, COATED (TABLET) in 1 VIAL
2 NDC:0573-0151-13 3 VIAL (VIAL) in 1 PACKAGE
2 10 TABLET, COATED (TABLET) in 1 VIAL
3 NDC:0573-0151-10 10 VIAL (VIAL) in 1 PACKAGE
3 10 TABLET, COATED (TABLET) in 1 VIAL
4 NDC:0573-0151-21 1 BOTTLE (BOTTLE) in 1 CARTON
4 36 TABLET, COATED (TABLET) in 1 BOTTLE
5 NDC:0573-0151-14 1 VIAL (VIAL) in 1 BLISTER PACK
5 10 TABLET, COATED (TABLET) in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018989 05/18/1984
Advil 
ibuprofen tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0161
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ibuprofen (ibuprofen) ibuprofen 200 mg
Product Characteristics
Color BROWN (pinkish brown) Score no score
Shape OVAL (smooth in texture polished oval shaped tablet ) Size 15mm
Flavor Imprint Code Advil
Contains     
Packaging
# Item Code Package Description
1 NDC:0573-0161-35 1 BOTTLE (BOTTLE) in 1 CARTON
1 150 TABLET, COATED (TABLET) in 1 BOTTLE
2 NDC:0573-0161-51 1 BOTTLE (BOTTLE) in 1 CARTON
2 200 TABLET, COATED (TABLET) in 1 BOTTLE
3 NDC:0573-0161-85 1 BOTTLE (BOTTLE) in 1 CARTON
3 225 TABLET, COATED (TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018989 05/18/1984
Advil 
ibuprofen tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0166
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ibuprofen (ibuprofen) ibuprofen 200 mg
Product Characteristics
Color BROWN (one hemisphere is brown while the other hemisphere is yellow) Score no score
Shape CAPSULE (smooth in texture with polished surface) Size 16mm
Flavor Imprint Code Advil
Contains     
Packaging
# Item Code Package Description
1 NDC:0573-0166-51 1 BOTTLE (BOTTLE) in 1 CARTON
1 200 TABLET, COATED (TABLET) in 1 BOTTLE
2 NDC:0573-0166-85 225 TABLET, COATED (TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018989 05/18/1984
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

In Summary

Common side effects of Advil include: decreased hemoglobin. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to ibuprofen: oral capsule, oral capsule liquid filled, oral suspension, oral tablet, oral tablet chewable

Other dosage forms:

  • intravenous solution

Along with its needed effects, ibuprofen (the active ingredient contained in Advil) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking ibuprofen:

More common
  • Abdominal pain
  • acid or sour stomach
  • belching
  • bloating
  • cloudy urine
  • decrease in amount of urine
  • decrease in urine output or decrease in urine-concentrating ability
  • diarrhea
  • difficulty having a bowel movement (stool)
  • excess air or gas in stomach or intestines
  • full feeling
  • heartburn
  • indigestion
  • itching skin
  • pain or discomfort in chest, upper stomach, or throat
  • pale skin
  • passing gas
  • nausea
  • noisy, rattling breathing
  • rash with flat lesions or small raised lesions on the skin
  • shortness of breath
  • swelling of face, fingers, hands, feet, lower legs, or ankles
  • troubled breathing at rest
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vomiting
  • weight gain
Less common
  • Abdominal cramps
  • stomach soreness or discomfort
Rare
  • Agitation
  • back, leg, or stomach pains
  • bleeding gums
  • blistering, peeling, loosening of skin
  • blood in urine or stools
  • bloody, black, or tarry stools
  • blurred vision
  • burning feeling in chest or stomach
  • change in vision
  • chest pain
  • chills
  • clay-colored stools
  • coma
  • confusion
  • constipation
  • cough or hoarseness
  • dark urine
  • decreased urine output
  • depression
  • difficulty breathing
  • difficulty swallowing
  • dilated neck veins
  • dizziness
  • dry mouth
  • extreme fatigue
  • fast, irregular, pounding, or racing heartbeat or pulse
  • fever with or without chills
  • frequent urination
  • general body swelling
  • general feeling of tiredness or weakness
  • hair loss, thinning of hair
  • headache
  • hives or welts
  • hostility
  • impaired vision
  • increased blood pressure
  • increased volume of pale, dilute urine
  • irregular breathing
  • irritability
  • itching
  • joint or muscle pain
  • lab results that show problems with liver
  • lethargy
  • light-colored stools
  • loss of appetite
  • lower back or side pain
  • muscle twitching
  • nosebleeds
  • painful or difficult urination
  • pains in stomach, side, or abdomen, possibly radiating to the back
  • pinpoint red spots on skin
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • rash
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • redness of skin
  • seizures
  • severe abdominal pain, cramping, burning
  • severe and continuing nausea
  • sore throat
  • sores, ulcers, or white spots in mouth or on lips
  • stiff neck or back
  • stomach upset
  • stupor
  • swollen or painful glands
  • tenderness in stomach area
  • thirst
  • tightness in chest
  • unpleasant breath odor
  • upper right abdominal pain
  • vomiting of blood
  • vomiting of material that looks like coffee grounds
  • wheezing
  • yellow eyes and skin
Symptoms of overdose
  • Bluish lips or skin
  • difficulty sleeping
  • disorientation
  • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
  • drowsiness to profound coma
  • hallucination
  • lightheadedness or fainting
  • mood or other mental changes
  • muscle tremors
  • not breathing
  • rapid, deep breathing
  • restlessness
  • slow or irregular heartbeat
  • stomach cramps
  • sudden fainting
  • sweating

Some side effects of ibuprofen may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Continuing ringing or buzzing or other unexplained noise in ears
  • hearing loss
  • nervousness
Rare
  • Crying
  • depersonalization
  • discouragement
  • dry eyes
  • dysphoria
  • euphoria
  • feeling sad or empty
  • lack of appetite
  • loss of interest or pleasure
  • mental depression
  • paranoia
  • quick to react or overreact
  • rapidly changing moods
  • runny nose
  • sleepiness or unusual drowsiness
  • sleeplessness
  • sneezing
  • stuffy nose
  • trouble concentrating
  • trouble sleeping
  • unable to sleep

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