FDA label

What is ibuprofen used for?

The FDA-approved uses of ibuprofen, quoted from the Indications and Usage section of its DailyMed label.

Source: DailyMed SPL label file dated 2026-10-23. Publisher page

The FDA label says: “Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).”

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Ibuprofen, tablet, film coated

Indications and Usage, quoted from the label by Ascend Laboratories, LLC (ANDA091625). Cross-references to other label sections are left out.

Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis.

Ibuprofen tablets are indicated for relief of mild to moderate pain.

Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea.

Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted.

Source: DailyMed label, set id 9ce036ef-a22d-4fca-9a62-1b10978f7b26, version 10, effective June 5, 2026. NDC 67877-319, one of 195 listings for this product.

Ibuprofen, tablet

Indications and Usage, quoted from the label by Dr. Reddy's Laboratories Limited (ANDA075682). Cross-references to other label sections are left out.

Carefully consider the potential benefits and risks of Ibuprofentablets and other treatment options before deciding to use Ibuprofen.Use the lowest effective dose for the shortest duration consistent withindividual patient treatment goals (see WARNINGS ).

Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis.

Ibuprofen tablets are indicated for relief of mild to moderate pain.

Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea.

Controlled clinical trials to establish the safety and effectiveness of Ibuprofen tablets in children have not been conducted.

Source: DailyMed label, set id 24731405-219c-79b4-ecf0-7d5fbfda94ba, version 15, effective July 2, 2025. NDC 55111-682, one of 114 listings for this product.

Ibuprofen, suspension

Indications and Usage, quoted from the label by Sun Pharmaceutical Industries, Inc. (ANDA209204). Cross-references to other label sections are left out.

Carefully consider the potential benefits and risks of ibuprofen oral suspension and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ).

In Pediatric Patients, Ibuprofen Oral Suspension is indicated:

  • For reduction of fever in patients aged 6 months up to 2 years of age.
  • For relief of mild to moderate pain in patients aged 6 months up to 2 years of age.
  • For relief of signs and symptoms of juvenile arthritis.

In Adults, Ibuprofen Oral Suspension is indicated:

  • For treatment of primary dysmenorrhea.
  • For relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis.

Since there have been no controlled trials to demonstrate whether there is any beneficial effect or harmful interaction with the use of ibuprofen in conjunction with aspirin, the combination cannot be recommended (see PRECAUTIONS-Drug Interactions ).

Source: DailyMed label, set id a8b46ae5-67bc-494d-850e-b4e4ed5a33b3, version 8, effective December 27, 2025. NDC 51672-1385, one of 9 listings for this product.

Questions

What is ibuprofen used for?

The FDA label says: “Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).”

What drug class is ibuprofen?

FDA lists ibuprofen in the Nonsteroidal Anti-inflammatory Drug established pharmacologic class.

Does this page cover off-label uses or dosing?

No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.

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