Ibuprofen

Ibuprofen
SPL v1
SPL
SPL Set ID ca9498ec-755d-4a09-9504-210dd48d6fed
Route
ORAL
Published
Effective Date 2018-10-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (200 mg)
Inactive Ingredients
Carnauba Wax Silicon Dioxide Starch, Corn Hypromellose, Unspecified Anhydrous Lactose Magnesium Stearate Microcrystalline Cellulose Polydextrose Polyethylene Glycol, Unspecified Ferric Oxide Red Sodium Starch Glycolate Type A Potato Stearic Acid Titanium Dioxide

Identifiers & Packaging

Marketing Status
ANDA Active Since 2018-10-15

Description

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

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

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

Uses

temporarily relieves minor aches and pains due to:

  • toothache
  • the common cold
  • menstrual cramps
  • backache
  • headache
  • 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 (1-800-222-1222) right away.

Section 51945-4

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:

  • facial swelling
  • hives
  • asthma (wheezing)
  • rash
  • shock
  • skin reddening
  • 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

  • take more or for a longer time than directed
  • are age 60 or older
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs [aspirin,

    ibuprofen, naproxen, or others]
  • have had stomach ulcers or bleeding problems
  • have 3 or more alcoholic drinks every day while using this product

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.

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/fever

    reducer
  • right before or after heart surgery
Other Information
  • use by expiration date on package
  • store between 20°-25°C (68°-77°F)
  • avoid excessive heat 40°C (104°F)
Inactive Ingredients

carnauba wax, colloidal silicon dioxide, corn starch, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose,

polydextrose, polyethylene glycol, red iron oxide, sodium starch glycolate, stearic acid, titanium dioxide

Questions Or Comments?

Call 1-800-736-3437 8:30 AM-5:00 PM ET, Monday-Friday

When Using This Product

take with food or milk if stomach upset occurs

Ask A Doctor Before Use If
  • 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
  • you have problems or serious side effects from taking pain relievers or fever reducers
Stop Use and Ask A Doctor If
  • you experience any of the following signs of stomach bleeding:
    • have bloody or black stools ­
    • vomit blood ­
    • feel faint
    • 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
Active Ingredient (in Each Brown Tablet)

Ibuprofen USP, 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:

  • toothache
  • the common cold
  • menstrual cramps
  • backache
  • headache
  • 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 (1-800-222-1222) right away.

Section 51945-4 (51945-4)

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:

  • facial swelling
  • hives
  • asthma (wheezing)
  • rash
  • shock
  • skin reddening
  • 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

  • take more or for a longer time than directed
  • are age 60 or older
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs [aspirin,

    ibuprofen, naproxen, or others]
  • have had stomach ulcers or bleeding problems
  • have 3 or more alcoholic drinks every day while using this product

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.

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/fever

    reducer
  • right before or after heart surgery
Other Information (Other information)
  • use by expiration date on package
  • store between 20°-25°C (68°-77°F)
  • avoid excessive heat 40°C (104°F)
Inactive Ingredients (Inactive ingredients)

carnauba wax, colloidal silicon dioxide, corn starch, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose,

polydextrose, polyethylene glycol, red iron oxide, sodium starch glycolate, stearic acid, titanium dioxide

Questions Or Comments? (Questions or comments?)

Call 1-800-736-3437 8:30 AM-5:00 PM ET, Monday-Friday

When Using This Product (When using this product)

take with food or milk if stomach upset occurs

Ask A Doctor Before Use If (Ask a doctor before use if)
  • 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
  • you have problems or serious side effects from taking pain relievers or fever reducers
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you experience any of the following signs of stomach bleeding:
    • have bloody or black stools ­
    • vomit blood ­
    • feel faint
    • 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
Active Ingredient (in Each Brown Tablet) (Active ingredient (in each brown tablet))

Ibuprofen USP, 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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