Ibuprofen

Ibuprofen
SPL v3
SPL
SPL Set ID 1c1374e1-890f-48ab-8f93-e84da9d5bf84
Route
ORAL
Published
Effective Date 2024-01-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (200 mg)
Inactive Ingredients
Croscarmellose Sodium Magnesium Stearate Cellulose, Microcrystalline Silicon Dioxide Titanium Dioxide Starch, Corn Polyvinyl Alcohol, Unspecified Talc Triacetin Hypromelloses Polyethylene Glycol, Unspecified

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-01-01

Description

Active Ingredient (in each tablet): Ibuprofen (NSAID*) 200mg (*nonsteroidal anti-inflammatory drug)


Medication Information

Warnings and Precautions

Warnings:

Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

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

Stomach bleeding warning: This product contains an NSAID, which may cause stomach bleeding. The chance is higher if you:

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take more or for a longer time than directed
  • take a blood thinning (anticoagulant) or steroid drug
  • have 3 or more alcoholic drinks every day while using this product
  • take other drugs containing prescription or non-prescriptin NSAIDs (aspirin, ibuprofen, naproxen, or others)

Indications and Usage

Uses: Temporarily relieves minor aches and pains due to

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

Temporarily reduces fever

Dosage and Administration

Directions:

Do not take more than directed; the smallest effective dose should be used.

Adults and children 12 years of age and over:

  • take 1 tablet every 4 to 6 hours while symptoms persist
  • if pain or fever does not respond to 1 tabet, 2 tablets may be used
  • do not take more than 6 tablets in 24 hours unless directed by a doctor

Children under 12 years of age: ask a doctor

Description

Active Ingredient (in each tablet): Ibuprofen (NSAID*) 200mg (*nonsteroidal anti-inflammatory drug)

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

  • an allergic reaction occurs, seek medical help right away
  • fever gets worse or lasts more than 3 days
  • pain gets worse or lasts more than 10 days
  • redness or swelling is present in the painful area
  • new symptoms occur
  • you have any of the following signs of stomach bleeding: feel faint, vomit blood, have bloody or black stools, or stomach pain that does not get better
Section 50567-7

When using this product

  • take with food or milk if stomach upset occurs
  • long term continuous use may increase the risk of heart attack or stroke
Section 50568-5

Ask a doctor or pharmacist before use if you

  • take any other drug containing an NSAID
  • take a blood thinning (anticoagulant) or steroid drug
  • take aspirin for heart attach or stroke (ibuprofen may decrease the benefit if aspirin)
  • are under a doctor's care for any serious condition

Section 50569-3

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, or kidney disease
  • 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 51727-6

Inactive Ingredients: Colloidal Silicon Dioxide, Corn Starch*, Croscarmellose Sodium*, Hypromellose*, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol*, Polyvinyl Alcohol*, Pregelantinized Starch, Red Iron Oxide, Sodium Starch Glycolate*, Talc, Titanium Dioxide, Triacetin*.

*Contains one or more of these ingredients.

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

Section 55105-1

Purpose: Pain Reliever / Fever Reducer

Section 55106-9

Active Ingredient (in each tablet): Ibuprofen (NSAID*) 200mg (*nonsteroidal anti-inflammatory drug)


Structured Label Content

Indications and Usage (34067-9)

Uses: Temporarily relieves minor aches and pains due to

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

Temporarily reduces fever

Dosage and Administration (34068-7)

Directions:

Do not take more than directed; the smallest effective dose should be used.

Adults and children 12 years of age and over:

  • take 1 tablet every 4 to 6 hours while symptoms persist
  • if pain or fever does not respond to 1 tabet, 2 tablets may be used
  • do not take more than 6 tablets in 24 hours unless directed by a doctor

Children under 12 years of age: ask a doctor

Warnings and Precautions (34071-1)

Warnings:

Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

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

Stomach bleeding warning: This product contains an NSAID, which may cause stomach bleeding. The chance is higher if you:

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take more or for a longer time than directed
  • take a blood thinning (anticoagulant) or steroid drug
  • have 3 or more alcoholic drinks every day while using this product
  • take other drugs containing prescription or non-prescriptin NSAIDs (aspirin, ibuprofen, naproxen, or others)

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

  • an allergic reaction occurs, seek medical help right away
  • fever gets worse or lasts more than 3 days
  • pain gets worse or lasts more than 10 days
  • redness or swelling is present in the painful area
  • new symptoms occur
  • you have any of the following signs of stomach bleeding: feel faint, vomit blood, have bloody or black stools, or stomach pain that does not get better
Section 50567-7 (50567-7)

When using this product

  • take with food or milk if stomach upset occurs
  • long term continuous use may increase the risk of heart attack or stroke
Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you

  • take any other drug containing an NSAID
  • take a blood thinning (anticoagulant) or steroid drug
  • take aspirin for heart attach or stroke (ibuprofen may decrease the benefit if aspirin)
  • are under a doctor's care for any serious condition

Section 50569-3 (50569-3)

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, or kidney disease
  • 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 51727-6 (51727-6)

Inactive Ingredients: Colloidal Silicon Dioxide, Corn Starch*, Croscarmellose Sodium*, Hypromellose*, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol*, Polyvinyl Alcohol*, Pregelantinized Starch, Red Iron Oxide, Sodium Starch Glycolate*, Talc, Titanium Dioxide, Triacetin*.

*Contains one or more of these ingredients.

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

Section 55105-1 (55105-1)

Purpose: Pain Reliever / Fever Reducer

Section 55106-9 (55106-9)

Active Ingredient (in each tablet): Ibuprofen (NSAID*) 200mg (*nonsteroidal anti-inflammatory drug)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)