Ibuprofen Tablet, Film Coated
FDA Label NDC 59779-438

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy for the product Ibuprofen (NDC 59779-438). 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 white tablet), purpose, uses, warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient (in Each White Tablet)

→ Purpose

→ Uses

→ Warnings

→ Do Not Use

→ Ask A Doctor Before Use If

→ Ask A Doctor Or Pharmacist Before Use If You Are

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ If Pregnant Or Breast-feeding,

→ Keep Out Of Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Principal Display Panel

Active Ingredient (In Each White Tablet)

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

Purpose

Pain reliever/fever reducer

Uses

temporarily relieves minor aches and pains due to:

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

temporarily reduces fever

Warnings

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

Symptoms may include:

rash
facial swelling
asthma (wheezing)
hives
skin reddening
shock
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:

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

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.

Do Not Use

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

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, kidney disease, asthma, or had a stroke
you are taking a diuretic
you have problems or serious side effects from taking pain relievers or fever reducers

Ask A Doctor Or Pharmacist Before Use If You Are

under a doctor's care for any serious condition
taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
taking any other drug

When Using This Product

take with food or milk if stomach upset occurs

Stop Use And Ask A Doctor If

you experience any of the following signs of stomach bleeding:

feel faint
have bloody or black stools
vomit blood
have stomach pain that does not get better

you have symptoms of heart problems or stroke

chest pain
slurred speech
leg swelling
trouble breathing
weakness in one part or side of body

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,

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.

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

Directions

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

store between 20°-25°C (68°-77°F)
avoid excessive heat 40°C (104°F)
use by expiration date on package

Inactive Ingredients

corn starch, colloidal silicon dioxide, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium starch glycolate, stearic acid, triacetin