Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 3ca752d8-957c-21b4-e063-6294a90a5285
Route
ORAL
Published
Effective Date 2022-10-17
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


Medication Information

Purpose

Pain reliever/Fever reducer

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
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 directed
  • 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 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 at 20 weeks or later in 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 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
Principal Display Panel 100 Tablet Bottle Label

Advil ®

Ibuprofen Tablets, 200 mg

Pain Reliever/Fever Reducer (NSAID)

100 Tablets

Tablets

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.

Principal Display Panel 24 Caplet Bottle Carton

NDC 0573-0160-20

Advil

Ibuprofen Tablets, 200 mg

Pain Reliever/Fever Reducer (NSAID)

24 Coated Caplets*

*Capsule-Shaped Tablets

Caplets

000067201 Front Carton

Principal Display Panel 24 Tablet Bottle Carton

NDC 0573-0150-20

Advil

Ibuprofen Tablets, 200 mg

Pain Reliever/Fever Reducer (NSAID)

24 Coated Tablets

Tablets

000067199 Front Carton

Principal Display Panel 300 Tablet Bottle Label

Advil ®

Ibuprofen Tablets, 200 mg

Pain Reliever/Fever Reducer (NSAID)

300 Coated Tablets

Tablets

Principal Display Panel 225 Caplet Bottle Label

NDC 0573-1711-14

Advil®

Ibuprofen Tablets, 200 mg

Pain Reliever/Fever Reducer (NSAID)

225 Caplets

Caplets

READ AND KEEP CARTON FOR COMPLETE

WARNINGS AND INFORMATION

PAA085439 Bottle Label

Principal Display Panel 115 Tablet Bottle Carton

15

FREE

TABLETS

Advil ®

Ibuprofen Tablets, 200 mg

Pain Reliever/Fever Reducer (NSAID)

115

Coated Tablets

Tablets

Principal Display Panel 225 Caplet Bottle Carton

25

FREE

CAPLETS

Advil ®

Ibuprofen Tablets, 200 mg

Pain Reliever/Fever Reducer (NSAID)

225

Coated Caplets*

*Capsule-Shaped Tablets

Caplets

Principal Display Panel – 100 Gel Caplet Bottle Carton

NDC 0573-0165-40

Advil

Ibuprofen Tablets, 200 mg

Pain Reliever / Fever Reducer (NSAID)

100 Coated Gel Caplets*

*Capsule-Shaped Gelatin-Coated Tablets

Gel

Caplets

000067202 Front Carton


Structured Label Content

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

Pain reliever/Fever reducer

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
Advil Caplets
  • do not take more than directed
  • 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 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 at 20 weeks or later in 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 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
Principal Display Panel 100 Tablet Bottle Label (PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label)

Advil ®

Ibuprofen Tablets, 200 mg

Pain Reliever/Fever Reducer (NSAID)

100 Tablets

Tablets

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.

Principal Display Panel 24 Caplet Bottle Carton (PRINCIPAL DISPLAY PANEL - 24 Caplet Bottle Carton)

NDC 0573-0160-20

Advil

Ibuprofen Tablets, 200 mg

Pain Reliever/Fever Reducer (NSAID)

24 Coated Caplets*

*Capsule-Shaped Tablets

Caplets

000067201 Front Carton

Principal Display Panel 24 Tablet Bottle Carton (PRINCIPAL DISPLAY PANEL - 24 Tablet Bottle Carton)

NDC 0573-0150-20

Advil

Ibuprofen Tablets, 200 mg

Pain Reliever/Fever Reducer (NSAID)

24 Coated Tablets

Tablets

000067199 Front Carton

Principal Display Panel 300 Tablet Bottle Label (PRINCIPAL DISPLAY PANEL - 300 Tablet Bottle Label)

Advil ®

Ibuprofen Tablets, 200 mg

Pain Reliever/Fever Reducer (NSAID)

300 Coated Tablets

Tablets

Principal Display Panel 225 Caplet Bottle Label (Principal Display Panel - 225 Caplet Bottle Label)

NDC 0573-1711-14

Advil®

Ibuprofen Tablets, 200 mg

Pain Reliever/Fever Reducer (NSAID)

225 Caplets

Caplets

READ AND KEEP CARTON FOR COMPLETE

WARNINGS AND INFORMATION

PAA085439 Bottle Label

Principal Display Panel 115 Tablet Bottle Carton (PRINCIPAL DISPLAY PANEL - 115 Tablet Bottle Carton)

15

FREE

TABLETS

Advil ®

Ibuprofen Tablets, 200 mg

Pain Reliever/Fever Reducer (NSAID)

115

Coated Tablets

Tablets

Principal Display Panel 225 Caplet Bottle Carton (PRINCIPAL DISPLAY PANEL - 225 Caplet Bottle Carton)

25

FREE

CAPLETS

Advil ®

Ibuprofen Tablets, 200 mg

Pain Reliever/Fever Reducer (NSAID)

225

Coated Caplets*

*Capsule-Shaped Tablets

Caplets

Principal Display Panel – 100 Gel Caplet Bottle Carton (PRINCIPAL DISPLAY PANEL – 100 Gel Caplet Bottle Carton)

NDC 0573-0165-40

Advil

Ibuprofen Tablets, 200 mg

Pain Reliever / Fever Reducer (NSAID)

100 Coated Gel Caplets*

*Capsule-Shaped Gelatin-Coated Tablets

Gel

Caplets

000067202 Front Carton


Advanced Ingredient Data


Raw Label Data

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