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Ibuprofen by Central Texas Community Health Centers

Medically reviewed on April 19, 2018

Dosage form: tablet, film coated
Ingredients: IBUPROFEN 200mg
Labeler: Central Texas Community Health Centers
NDC Code: 76413-313

Ibuprofen

Active ingredient (in each tablet)

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

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 chances are 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

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

Ask a doctor or pharmacist before use if you are
taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
under a doctor's care for any serious condition
taking any other drug

When using this product
take with food or milk if stomach upset occurs
the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stop use and ask a doctor if
you experience any of the following signs of stomach bleeding:
feel faint
vomit blood
have bloody or black stools
have stomach pain that does not get better
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 right away. (1-800-222-1222)

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 at 20-25°C (68-77°F)
avoid high humidity and excessive heat above 40°C (104°F)

Inactive ingredients

colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow, microcrystalline cellulose, polyethylene glycol, polysorbate 80, stearic acid, titanium dioxide

Questions or comments?

1-800-719-9260

PRINCIPAL DISPLAY PANEL - 200 MG Tablet Bottle Label

CommUnityCare Federally Qualified Health Centers

IBUPROFEN
200MG #24
TABLETS

Date:

Name:
Dr.

Take as directed

123456

1/1/01

IBUPROFEN 200MG #24 TABS NDC 76413-313-24

Batch: 123456
Lot: 123456
Exp: 1/1/01
SUNMARK

Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.

IBUPROFEN 
ibuprofen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76413-313(NDC:49348-706)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
STARCH, CORN 
CROSCARMELLOSE SODIUM 
HYPROMELLOSES 
CELLULOSE, MICROCRYSTALLINE 
STEARIC ACID 
TITANIUM DIOXIDE 
POLYSORBATE 80 
POLYETHYLENE GLYCOLS 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
Product Characteristics
ColorBROWNScoreno score
ShapeROUNDSize10mm
FlavorImprint CodeI2
Contains    
Packaging
#Item CodePackage Description
1NDC:76413-313-241 BOTTLE in 1 CARTON
124 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07209606/24/2003
Labeler - Central Texas Community Health Centers (079674019)
Establishment
NameAddressID/FEIOperations
Central Texas Community Health Centers079674019REPACK(76413-313), RELABEL(76413-313)

 
Central Texas Community Health Centers

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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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