Ibuprofen Tablet
FDA Label NDC 84324-038

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Nuvicare Llc for the product Ibuprofen (NDC 84324-038). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each tablet), purposes, uses, warnings, directions, other information, inactive ingredients, questions or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Tablet)

Ibuprofen 200 mg (NSAID)* 

*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

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

Warnings

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.

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

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 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

Other Information

■ read all warnings and directions before use

■ store between 20-25°C (68-77°F)

■ avoid high humidity and excessive heat above 40°C (104°F)

Inactive Ingredients

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

* Please review the disclaimer below.