Advil Tablets

Advil Tablets
SPL v3
SPL
SPL Set ID f55d1c51-67ec-459c-b120-b563b97c71ff
Route
ORAL
Published
Effective Date 2019-05-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (200 mg)
Inactive Ingredients
Microcrystalline Cellulose Croscarmellose Sodium Ferric Oxide Red Methylparaben Povidone, Unspecified Propylparaben Shellac Silicon Dioxide Sodium Benzoate Sodium Lauryl Sulfate Starch, Corn Stearic Acid Sucrose Titanium Dioxide White Wax Diacetylated Monoglycerides

Identifiers & Packaging

Pill Appearance
Imprint: Advil Shape: round Color: brown Size: 11 mm Score: 1
Marketing Status
NDA Active Since 1984-05-18

Description

Ibuprofen 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/Fever reducer

How Supplied

Product: 52904-794 NDC: 52904-794-05 2 TABLET, COATED in a POUCH / 1 in a CARTON NDC: 52904-794-01 2 TABLET, COATED in a POUCH / 1 in a BLISTER PACK NDC: 52904-794-02 2 TABLET, COATED in a POUCH / 2 in a BLISTER PACK NDC: 52904-794-06 2 TABLET, COATED in a POUCH / 2 in a CARTON Product: 52904-786 NDC: 52904-786-50 2 TABLET, COATED in a POUCH / 50 in a CASE Product: 52904-790 NDC: 52904-790-30 2 TABLET, COATED in a POUCH / 30 in a CASE Product: 52904-791 NDC: 52904-791-25 2 TABLET, COATED in a POUCH / 25 in a CASE


Medication Information

Purpose

Pain reliever/Fever reducer

How Supplied

Product: 52904-794

NDC: 52904-794-05 2 TABLET, COATED in a POUCH / 1 in a CARTON

NDC: 52904-794-01 2 TABLET, COATED in a POUCH / 1 in a BLISTER PACK

NDC: 52904-794-02 2 TABLET, COATED in a POUCH / 2 in a BLISTER PACK

NDC: 52904-794-06 2 TABLET, COATED in a POUCH / 2 in a CARTON

Product: 52904-786

NDC: 52904-786-50 2 TABLET, COATED in a POUCH / 50 in a CASE

Product: 52904-790

NDC: 52904-790-30 2 TABLET, COATED in a POUCH / 30 in a CASE

Product: 52904-791

NDC: 52904-791-25 2 TABLET, COATED in a POUCH / 25 in a CASE

Description

Ibuprofen 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug

Uses
  • temporarily relieves minor aches and pains due to:
    • headache
    • toothache
    • backache
    • menstrual cramps
    • the common cold
    • muscular aches
    • minor pain of arthritis
  • temporarily reduces fever
Ibuprofen
Do Not Use
  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery
Advil Caplets
  • do not take more than directe d
  • the smallest effective dose should be used
  • adults and children 12 years and over: take 1 caplet every 4 to 6 hours while symptoms persist
  • if pain or fever does not respond to 1 caplet, 2 caplets may be used
  • do not exceed 6 caplets in 24 hours, unless directed by a doctor
  • children under 12 years: ask a doctor
Advil Tablets
  • do not take more than directed
  • the smallest effective dose should be used
  • adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persist
  • if pain or fever does not respond to 1 tablet, 2 tablets may be used
  • do not exceed 6 tablets in 24 hours, unless directed by a doctor
  • children under 12 years: ask a doctor
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.

Advil (ibuprofen)
Advil Gel Caplets
  • do not take more than directed
  • the smallest effective dose should be used
  • adults and children 12 years and over: take 1 gel caplet every 4 to 6 hours while symptoms persist
  • if pain or fever does not respond to 1 gel caplet, 2 gel caplets may be used
  • do not exceed 6 gel caplets in 24 hours, unless directed by a doctor
  • children under 12 years: ask a doctor
Other Information
  • read all warnings and directions before use. Keep carton.
  • store at 20-25°C (68-77°F)
  • avoid excessive heat above 40°C (104°F)
Questions Or Comments?

call toll free 1-800-88-ADVIL

When Using This Product
  • take with food or milk if stomach upset occurs
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
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, asthma, or had a stroke
  • you are taking a diuretic
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
  • you have symptoms of heart problems or stroke:
    • chest pain
    • trouble breathing
    • weakness in one part or side of body
    • slurred speech
    • leg swelling
  • 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
Advil Caplets (in Each Caplet)

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Advil Tablets (in Each Tablet)

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

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.

Heart Attack and Stroke Warning

NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Advil (ibuprofen) Tablet, Coated
Advil Gel Caplets (in Each Gel Caplet)

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

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

Structured Label Content

Uses (USES)
  • temporarily relieves minor aches and pains due to:
    • headache
    • toothache
    • backache
    • menstrual cramps
    • the common cold
    • muscular aches
    • minor pain of arthritis
  • temporarily reduces fever
Purpose (PURPOSE)

Pain reliever/Fever reducer

Ibuprofen (IBUPROFEN)
Do Not Use (Do not use)
  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery
How Supplied (HOW SUPPLIED)

Product: 52904-794

NDC: 52904-794-05 2 TABLET, COATED in a POUCH / 1 in a CARTON

NDC: 52904-794-01 2 TABLET, COATED in a POUCH / 1 in a BLISTER PACK

NDC: 52904-794-02 2 TABLET, COATED in a POUCH / 2 in a BLISTER PACK

NDC: 52904-794-06 2 TABLET, COATED in a POUCH / 2 in a CARTON

Product: 52904-786

NDC: 52904-786-50 2 TABLET, COATED in a POUCH / 50 in a CASE

Product: 52904-790

NDC: 52904-790-30 2 TABLET, COATED in a POUCH / 30 in a CASE

Product: 52904-791

NDC: 52904-791-25 2 TABLET, COATED in a POUCH / 25 in a CASE

Advil Caplets
  • do not take more than directe d
  • the smallest effective dose should be used
  • adults and children 12 years and over: take 1 caplet every 4 to 6 hours while symptoms persist
  • if pain or fever does not respond to 1 caplet, 2 caplets may be used
  • do not exceed 6 caplets in 24 hours, unless directed by a doctor
  • children under 12 years: ask a doctor
Advil Tablets
  • do not take more than directed
  • the smallest effective dose should be used
  • adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persist
  • if pain or fever does not respond to 1 tablet, 2 tablets may be used
  • do not exceed 6 tablets in 24 hours, unless directed by a doctor
  • children under 12 years: ask a doctor
Allergy Alert: (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.

Advil (ibuprofen) (ADVIL (IBUPROFEN))
Advil Gel Caplets
  • do not take more than directed
  • the smallest effective dose should be used
  • adults and children 12 years and over: take 1 gel caplet every 4 to 6 hours while symptoms persist
  • if pain or fever does not respond to 1 gel caplet, 2 gel caplets may be used
  • do not exceed 6 gel caplets in 24 hours, unless directed by a doctor
  • children under 12 years: ask a doctor
Other Information (OTHER INFORMATION)
  • read all warnings and directions before use. Keep carton.
  • store at 20-25°C (68-77°F)
  • avoid excessive heat above 40°C (104°F)
Questions Or Comments? (Questions or comments?)

call toll free 1-800-88-ADVIL

When Using This Product (When using this product)
  • take with food or milk if stomach upset occurs
Stomach Bleeding Warning: (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
Ask A Doctor Before Use If (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, asthma, or had a stroke
  • you are taking a diuretic
Stop Use and Ask A Doctor If (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
  • you have symptoms of heart problems or stroke:
    • chest pain
    • trouble breathing
    • weakness in one part or side of body
    • slurred speech
    • leg swelling
  • 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
Advil Caplets (in Each Caplet) (Advil Caplets (in each caplet))

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Advil Tablets (in Each Tablet) (Advil Tablets (in each tablet))

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

If Pregnant Or Breast Feeding, (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. (Keep out of reach of children.)

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

Heart Attack and Stroke Warning (Heart attack and stroke warning)

NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Advil (ibuprofen) Tablet, Coated (ADVIL (IBUPROFEN) TABLET, COATED)
Advil Gel Caplets (in Each Gel Caplet) (Advil Gel Caplets (in each gel caplet))

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Ask A Doctor Or Pharmacist Before Use If You Are (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

Advanced Ingredient Data


Raw Label Data

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