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IBUPROFEN by International Laboratories, LLC

Medically reviewed on April 6, 2017

Dosage form: tablet
Ingredients: IBUPROFEN 200mg
Labeler: International Laboratories, LLC
NDC Code: 54458-850

International Laboratories, Inc. Ibuprofen Tablets Drug Facts

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 or 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
• rash
• asthma (wheezing)
• skin reddening
• blisters
• shock

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]
• take more or for a longer time than directed
• have 3 or more alcoholic drinks every day while using this product

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

the 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 have asthma
• you are taking a diuretic

Ask a doctor or pharmacist before use if you are

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

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

 • the smallest effective dose should be used
 • do not take more than directed
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 tables 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 20-25ºC (68-77ºF)
 • avoid high humidity and excessive heat above 40ºC (104ºF)
 • see back panel for lot number and expiration date

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?

 1-800-579-1868

PRINCIPAL DISPLAY PANEL

Drug Facts Label

 

Drug Facts

PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in Advil®

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Ibuprofen

TABLETS, 200 mg

Pain reliever; Fever reducer (NSAID)

14 COATED TABLETS

Actual Size

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Ibuprofen

 

IBUPROFEN 
ibuprofen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54458-850
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:54458-850-1414 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07209606/01/2016
Labeler - International Laboratories, LLC (023569924)
Establishment
NameAddressID/FEIOperations
International Laboratories, LLC023569924RELABEL(54458-850), REPACK(54458-850)
Establishment
NameAddressID/FEIOperations
L. Perrigo Company006013346MANUFACTURE(54458-850), RELABEL(54458-850), REPACK(54458-850)

 
International Laboratories, LLC

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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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