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Ibuprofen by Cardinal Health

Medically reviewed on October 26, 2017

Dosage form: tablet, film coated
Ingredients: IBUPROFEN 200mg
Labeler: Cardinal Health
NDC Code: 55154-0669

Ibuprofen Tablets USP, 200 mg

DRUG FACTS

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
the common cold
temporarily reduces fever
headache
minor pain of arthritis
backache
menstrual cramps
toothache

WARNINGS SECTION

Read all warnings and directions before use.

SEE NEW WARNINGS INFORMATION

This unit dose package is not child resistant and is intended for institutional use only.

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 an 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.

Do not use
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
stomach bleeding warning applies to you 
you have problems or serious side effects from taking pain relievers or fever reducers 
you have a history of stomach problems, such as heartburn
you have high blood pressure, heart disease, liver cirrhosis or kidney disease
you are taking a diuretic
you have asthma or had a stroke

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 must be used

DOSAGE & ADMINISTRATION SECTION
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: Store between 20-25ºC (68º-77ºF); Avoid excessive heat 40C (104F)

TAMPER EVIDENT: DO NOT USE IF BLISTER IS TORN OR BROKEN

INACTIVE INGREDIENTS

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

Questions or comments?

Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

Distributed By:

Major® Pharmaceuticals

17177 N Laurel Park Dr., Suite 233

Livonia, MI 48152 USA

MFGD By LNK, Hauppauge, NY 11788

Repackaged By:

Cardinal Health

Zanesville, OH 43701

L3432333-10917

L3432333-20917

Principal Display Panel

Ibuprofen Tablets, USP 200 mg.

Pain Reliever/Fever Reducer (NSAID)

10 Tablets

IBUPROFEN 
ibuprofen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-0669(NDC:0904-7914)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
MICROCRYSTALLINE CELLULOSE 
STARCH, CORN 
SILICON DIOXIDE 
HYPROMELLOSE, UNSPECIFIED 
LACTOSE, UNSPECIFIED FORM 
MAGNESIUM STEARATE 
POLYDEXTROSE 
POLYETHYLENE GLYCOL, UNSPECIFIED 
CROSPOVIDONE, UNSPECIFIED 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
TITANIUM DIOXIDE 
TRIACETIN 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize10mm
FlavorImprint Code44;438
Contains    
Packaging
#Item CodePackage Description
1NDC:55154-0669-010 BLISTER PACK in 1 BAG
11 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07513906/03/2011
Labeler - Cardinal Health (188557102)
Establishment
NameAddressID/FEIOperations
Cardinal Health188557102REPACK(55154-0669)

 
Cardinal Health

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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