IBUPROFEN- ibuprofen tablet 
CARDINAL HEALTH

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611R Leader Cardinal 70000-0597 Ibuprofen Tablets USP 200 mg

Drug Facts

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:
o headache
o muscular aches
o minor pain of arthritis
o toothache
o backache
o the common cold
o 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 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: 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 ibuprofen or 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, kidney disease, asthma, or had a stroke
• 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

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
you have symptoms of heart problems or stroke:
• chest pain
• trouble breathing
• weakness in one part or side of body
• slurred speech
• leg swelling
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 at 20 weeks or later in 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
• store at 20-25ºC (68-77ºF)

Inactive ingredientscolloidal silicon dioxide, croscarmellose sodium, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide

Questions or comments? Call 1-877-290-4008

611R-LC-ibuprofen-label-100s611R-LC-ibuprofen-label-50s611R-LC-ibuprofen-ifc-50s611R-LC-ibuprofen-ifc-100s

IBUPROFEN 
ibuprofen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0597
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize10mm
FlavorImprint Code 115
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0597-21 in 1 CARTON05/25/2022
1100 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:70000-0597-11 in 1 CARTON05/25/2022
250 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09123705/25/2022
Labeler - CARDINAL HEALTH (063997360)
Registrant - TIME CAP LABORATORIES, INC. (037052099)
Establishment
NameAddressID/FEIBusiness Operations
MARKSANS PHARMA LIMITED925822975manufacture(70000-0597)

Revised: 5/2022
Document Id: dfbbde4f-633e-6d57-e053-2a95a90ad82f
Set id: dfbbde4f-633d-6d57-e053-2a95a90ad82f
Version: 1
Effective Time: 20220524
 
CARDINAL HEALTH