Ibuprofen

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Allergy alert

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chances are 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.

Do not use

OTC - DO NOT USE SECTION

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

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

■ you have problems or serious side effects from taking pain relievers or fever reducers ■ the 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 have asthma ■ you are taking a diuretic

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

■ taking aspirin to prevent 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

When using this product

OTC - WHEN USING SECTION

take with food or milk if stomach upset occursthe risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stop use and ask a doctor if

OTC - STOP USE SECTION

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 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

■ 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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Colloidal silicon dioxide, corn starch, FD&C Yellow #6 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide and triacetin

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

• Ibuprofen Pain reliever/fever reducer
• Ibuprofen 200 mg
• IBUPROFEN
• SILICON DIOXIDE
• STARCH, CORN
• FD&C YELLOW NO. 6
• HYPROMELLOSES
• MAGNESIUM STEARATE
• CELLULOSE, MICROCRYSTALLINE
• SODIUM STARCH GLYCOLATE TYPE A CORN
• TALC
• TITANIUM DIOXIDE
• TRIACETIN

NDC Codes#

Ingredients#

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DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

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Inactive ingredient links page 1 of 5 · 288 matching rows.

Orange Book application contexts#

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Orange Book application contexts page 1 of 1 · 1 matching rows.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

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Reported adverse events (FAERS/openFDA)#

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