Advil

Advil
SPL v4
SPL
SPL Set ID 4a64522f-b7d8-47f7-bf07-c9e8f1086425
Route
ORAL
Published
Effective Date 2016-09-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: Advil Shape: round Color: brown Size: 11 mm Score: 1
Marketing Status
NDA Active Since 2016-09-20 Until 2023-01-05

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 • the common cold • muscular aches • minor pain of arthritis • menstrual cramps

• temporarily reduces fever

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

Directions

• 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

Do Not Use

• if you have ever had an allergic reaction to any other pain reliever or fever reducer

• right before or after heart surgery

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)

Package Labeling:

Inactive Ingredients

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

Questions Or Comments?

Call toll free 1-800-88-ADVIL

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

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

Stop Use and Ask A Doctor If

• you expereince 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 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.

Active Ingredient (in Each Tablet)

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

• temporarily relieves minor aches and pains due to:

• headache • toothache • backache • the common cold • muscular aches • minor pain of arthritis • menstrual cramps

• temporarily reduces fever

Purpose

Pain Reliever/Fever Reducer

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

Directions

• 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

Do Not Use (Do not use)

• if you have ever had an allergic reaction to any other pain reliever or fever reducer

• right before or after heart surgery

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)

Package Labeling:

Inactive Ingredients (Inactive ingredients)

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

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

• the risk of heart attack or stroke may increase if you use more than directed or for longer 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, or asthma

• you are taking a diuretic

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

• you expereince 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, (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.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

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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