Ibuprofen

Ibuprofen
SPL v1
SPL
SPL Set ID 1ab6fbae-ead5-283b-e063-6394a90a4ed4
Route
ORAL
Published
Effective Date 2024-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (200 mg)
Inactive Ingredients
Hypromellose, Unspecified Magnesium Stearate Starch, Corn Talc Triacetin Microcrystalline Cellulose Ferric Oxide Red Sodium Starch Glycolate Type A Potato Silicon Dioxide Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: IBU200 Shape: round Color: brown Size: 10 mm Score: 1
Marketing Status
ANDA Active Since 2024-04-01

Description

Drug Facts

Purpose

Purposes Pain reliever/fever reducer


Medication Information

Purpose

Purposes Pain reliever/fever reducer

Description

Drug Facts

Uses

Uses

  • temporarily relieves minor aches and pains due to:
  • headache
  • muscular aches
  • minor pain of arthritis
  • toothache • backache
  • the common cold
  • menstrual cramps
  • temporarily reduces fever
Purposes

Purposes

Pain reliever/fever reducer

Warnings

Warnings

Directions

Directions

  • do not take more than directed
  • the smallest effective dose should be used
  • adults and children 12 years and older:
  • 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/fever reducer
  • right before or after heart surgery
Drug Facts

Drug Facts

Ask A Doctor

Ask a doctor before use if

  • you have problems or serious side effects from taking pain relievers or fever reducers
  • stomach bleeding warning applies to you
  • 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
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.

Active Ingredient

Active ingredient (in each Brown tablet)

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Other Information

Other information

  • store at 20°-25°C (68°-77°F)
Inactive Ingredients

Inactive ingredients

colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, red iron oxide, sodium starch glycolate, talc, titanium dioxide, triacetin

Ibuprofen, Casey's ®

SEE NEW WARNINGS

Ibuprofen

Tablets, USP 200 mg

Pain Reliever/Fever Reducer

(NSAID)*

Compare to the

active ingredients in

Advil Taablets**

*nonsteroidal

anti-inflammatory drug

[tablet image]

actual

size

[Casey's logo]

50 COATED

TABLETS

Questions Or Comments?

Questions or comments? Call toll-free

1-877-507-6516 (M-F 8AM-4:30PM CST)

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 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
Stop Use and Ask A Doctor

Stop use and ask a doctor if

  • you experience any of the following signs of stomach bleeding:
  • have bloody or black stools
  • feel faint
  • vomit blood
  • have stomach pain that does not get better
  • you have symptoms of heart problems or stroke:
  • chest pain
  • slurred speech
  • leg swelling
  • trouble breathing
  • weakness in one part or side of body
  • 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
Ask A Doctor Or Pharmacist

Ask a doctor or pharmacist before use if you are

  • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • under a doctor's care for any serious condition
  • taking any other drug
Ibuprofen, Lil' Drug Store ®

[caduceus]

Compare to the Active

Ingredient in Advil Tablets**

SEE NEW WARNINGS

Ibuprofen

Tablets, USP 200 mg

Pain reliever/Fever reducer (NSAID)*

*nonsteroidal anti-inflammatory drug

Gluten Free

[tablet image]

ACTUAL SIZE

50

Coated

Tablets

[Lil' Drug Store logo]

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. (1-800-222-1222)

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.

Ibuprofen, Circle K™, 50ct Pdp/package

SEE NEW WARNINGS

TEMPORARILY RELIEVES

MINOR ACHES & PAINS

Compare to the active ingredient

in Advil Tablets**

[Circle K logo]

200 mg

ibuprofen

Tablets, USP 200 mg

Pain reliever/Fever reducer (NSAID)*

*nonsteroidal anti-inflammatory drug

[tablet image]

actual size

50 coated tablets


Structured Label Content

Uses

Uses

  • temporarily relieves minor aches and pains due to:
  • headache
  • muscular aches
  • minor pain of arthritis
  • toothache • backache
  • the common cold
  • menstrual cramps
  • temporarily reduces fever
Purposes

Purposes

Pain reliever/fever reducer

Warnings

Warnings

Directions

Directions

  • do not take more than directed
  • the smallest effective dose should be used
  • adults and children 12 years and older:
  • 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)

Do not use

  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery
Drug Facts

Drug Facts

Ask A Doctor (Ask a doctor)

Ask a doctor before use if

  • you have problems or serious side effects from taking pain relievers or fever reducers
  • stomach bleeding warning applies to you
  • 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
Allergy Alert (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.

Active Ingredient (Active ingredient)

Active ingredient (in each Brown tablet)

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Other Information (Other information)

Other information

  • store at 20°-25°C (68°-77°F)
Inactive Ingredients (Inactive ingredients)

Inactive ingredients

colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, red iron oxide, sodium starch glycolate, talc, titanium dioxide, triacetin

Ibuprofen, Casey's ®

SEE NEW WARNINGS

Ibuprofen

Tablets, USP 200 mg

Pain Reliever/Fever Reducer

(NSAID)*

Compare to the

active ingredients in

Advil Taablets**

*nonsteroidal

anti-inflammatory drug

[tablet image]

actual

size

[Casey's logo]

50 COATED

TABLETS

Questions Or Comments? (Questions or comments?)

Questions or comments? Call toll-free

1-877-507-6516 (M-F 8AM-4:30PM CST)

When Using This Product (When using this product)

When using this product

  • take with food or milk if stomach upset occurs
Stomach Bleeding Warning (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 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
Stop Use and Ask A Doctor (Stop use and ask a doctor)

Stop use and ask a doctor if

  • you experience any of the following signs of stomach bleeding:
  • have bloody or black stools
  • feel faint
  • vomit blood
  • have stomach pain that does not get better
  • you have symptoms of heart problems or stroke:
  • chest pain
  • slurred speech
  • leg swelling
  • trouble breathing
  • weakness in one part or side of body
  • 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
Ask A Doctor Or Pharmacist (Ask a doctor or pharmacist)

Ask a doctor or pharmacist before use if you are

  • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • under a doctor's care for any serious condition
  • taking any other drug
Ibuprofen, Lil' Drug Store ®

[caduceus]

Compare to the Active

Ingredient in Advil Tablets**

SEE NEW WARNINGS

Ibuprofen

Tablets, USP 200 mg

Pain reliever/Fever reducer (NSAID)*

*nonsteroidal anti-inflammatory drug

Gluten Free

[tablet image]

ACTUAL SIZE

50

Coated

Tablets

[Lil' Drug Store logo]

If Pregnant Or Breast Feeding (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)

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)

Heart Attack and Stroke Warning (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.

Ibuprofen, Circle K™, 50ct Pdp/package (Ibuprofen, Circle K™, 50ct - PDP/Package)

SEE NEW WARNINGS

TEMPORARILY RELIEVES

MINOR ACHES & PAINS

Compare to the active ingredient

in Advil Tablets**

[Circle K logo]

200 mg

ibuprofen

Tablets, USP 200 mg

Pain reliever/Fever reducer (NSAID)*

*nonsteroidal anti-inflammatory drug

[tablet image]

actual size

50 coated tablets


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)