Ibuprofen

Drug Facts

SPL UNCLASSIFIED SECTION

Active Ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Ibuprofen 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 • toothache • backache • menstrual cramps • the common cold • muscular aches • minor pain of arthritis • temporarily reduces fever

Warnings

WARNINGS SECTION

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 a nonsteroidal anti-inflammatory drug (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: NSAID's except aspirin increases 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

DOSAGE & ADMINISTRATION SECTION

• 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

Other Information

STORAGE AND HANDLING SECTION

• read all warnings and directions before use. Keep carton. • store between 20°-25°C (68°-77°F) • avoid excessive heat above 40°C (104°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Colloidal silicon dioxide, corn starch, hypromellose, red iron oxide, magnesium stearate*, microcrystalline cellulose*, povidone K-30*, pregelatinized starch, sodium starch glycolate, stearic acid*, talc, titanium dioxide, triacetin *contains one or more of these ingredients

Questions or comments?

OTC - QUESTIONS SECTION

1-888-333-9792

Principal Display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Carton