Ibuprofen

Ibuprofen
SPL v6
SPL
SPL Set ID 86907912-79ce-4592-ab0c-9c6205b2f65c
Route
ORAL
Published
Effective Date 2022-06-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (200 mg)
Inactive Ingredients
Silicon Dioxide Microcrystalline Cellulose Starch, Corn Sodium Starch Glycolate Type A Corn Magnesium Stearate Hypromelloses Titanium Dioxide Triacetin Fd&c Red No. 40 Talc

Identifiers & Packaging

Pill Appearance
Imprint: IBU;200 Shape: round Color: brown Size: 10 mm Score: 1
Marketing Status
ANDA Active Since 2022-06-15

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

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Section 50566-9

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

Section 50567-7

When using this product

• take with food or milk if stomach upset occurs

Section 50568-5

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

Section 50569-3

Ask a doctor before use if • the 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

Section 50570-1

Do not use • if you have ever had an allergic reaction to any other pain reliever/fever reducer • right before or after heart surgery

Section 53414-9

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.

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 a nonsteroidal anti-inflammatory drug (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

Heart attack and stroke warning: NSAID's except aspirin increases 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.

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

Drug Facts

Other Information

• read all warnings and directions before use. Keep carton. • store between 20°-25°C (68°-77°F) • avoid excessive heat above 40°C (104°F)

Inactive Ingredients

colloidal silicon dioxide, corn starch, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, povidone K-30,pregelatinized starch, sodium starch glycolate, stearic acid, talc, titanium dioxide, triacetin

Questions Or Comments?

1-888-333-9792

Principal Display Panel

Compare to Advil® Tablets active ingredient†

ibuprofen



Ibuprofen Tablets, 200 mg



Pain Reliever / Fever Reducer (NSAID)

30 tablets

Active Ingredient (in Each Tablet)

Ibuprofen 200 mg (NSAID)**

**nonsteroidal anti-inflammatory drug


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

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

When using this product

• take with food or milk if stomach upset occurs

Section 50568-5 (50568-5)

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

Section 50569-3 (50569-3)

Ask a doctor before use if • the 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

Section 50570-1 (50570-1)

Do not use • if you have ever had an allergic reaction to any other pain reliever/fever reducer • right before or after heart surgery

Section 53414-9 (53414-9)

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.

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 a nonsteroidal anti-inflammatory drug (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

Heart attack and stroke warning: NSAID's except aspirin increases 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.

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

Drug Facts

Other Information

• read all warnings and directions before use. Keep carton. • store between 20°-25°C (68°-77°F) • avoid excessive heat above 40°C (104°F)

Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, corn starch, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, povidone K-30,pregelatinized starch, sodium starch glycolate, stearic acid, talc, titanium dioxide, triacetin

Questions Or Comments? (Questions or comments?)

1-888-333-9792

Principal Display Panel

Compare to Advil® Tablets active ingredient†

ibuprofen



Ibuprofen Tablets, 200 mg



Pain Reliever / Fever Reducer (NSAID)

30 tablets

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

Ibuprofen 200 mg (NSAID)**

**nonsteroidal anti-inflammatory drug


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)