IBUPROFEN tablet, film coated

Ibuprofen by

Drug Labeling and Warnings

Ibuprofen by is a Otc medication manufactured, distributed, or labeled by Chain Drug Consortium LLC, Marksans Pharma Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT(S)

Ibuprofen 200 mg (NSAID)*

·        nonsteroidal anti-inflammatory drug

PURPOSE

Pain reliever / fever reducer

USE(S)

• temporarily relieves minor aches and pain due to :
• backache
• headache
• menstrual cramps
• minor pain of arthritis
• muscular aches
• the common cold
• toothache
• Temporarily reduces fever

WARNINGS

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

Symptoms may include: 

• asthma (wheezing)
• blisters
• facial swelling
• hives
• rash
• shock
• skin reddening

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 stomach bleeding. The chance is higher if you:

• are age 60 or older
• have bad stomach ulcers or bleeding problems
• take a blood thinning (anticoagulant) or steroid drug
• take other drug containing prescription NSAID (aspirin, ibuprofen, naproxen, or others)
• have 3 or more alcoholic drinks every day while using this product
• the 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
• stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain
• ulcers
• bleeding problems
• high blood pressure
• heart or kidney disease
• taken a diuretics
• reached age 60 or older

ASK A DOCTOR OR PHARMACIST BEFORE USE IF

you are

• taking any other drugs containg an NSAID (prescription or nonprescription)
• taking a blood thining (anticoagulant) or steriod drug
• under a doctor’s care for any serious condition
• taking aspirin for heart attacks 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
• long term continuous use may increase the risk of heart attack or stroke

STOP USE AND ASK DOCTOR IF

• you feel faint, vomit blood, or have bloody or black stools.

        These are signs of stomach bleeding.

• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• stomach pain or upset gets worse or lasts
• redness or swelling is present in painful area
• any new symptoms appear

PREGNANCY/BREASTFEEDING

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 a 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 PoisonControlCenter right away.

DIRECTIONS

• do not take more than directed
• the smallest effective dose should be used
• do not take longer than 10 days, unless directed by a doctor
  (see Warnings)

         

• 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

INACTIVE INGREDIENT(S)

Colloidal silicon dioxide, Croscarmellose Sodium, Magnesium stearate, Microcrystalline sodium, Pregelatinised starch, talc.

STORAGE

• store between 20-25 0c (68-77 0 F).
• do not use if seal under bottle cap imprinted with” SEALED for YOUR PROTECTION” is broken or missing.

PRINCIPAL DISPLAY PANEL

Carton Label PDP

NDC# 68016-295-01

DYE FREE
Ibuprofen Tablets 200 mg

PAIN RELIEVER/FEVER REDUCER (NSAID)

SEE NEW WARNINGS INFORMATION

100 COATED TABLETS





Bottle Label PDP

NDC# 68016-295-01

DYE FREE
Ibuprofen Tablets 200 mg

PAIN RELIEVER/FEVER REDUCER (NSAID)

SEE NEW WARNINGS INFORMATION

100 COATED TABLETS




Carton Label PDP

NDC# 68016-295-50

DYE FREE
Ibuprofen Tablets 200 mg

PAIN RELIEVER/FEVER REDUCER (NSAID)

SEE NEW WARNINGS INFORMATION

50 COATED TABLETS





Bottle Label PDP

NDC# 68016-295-50

DYE FREE
Ibuprofen Tablets 200 mg

PAIN RELIEVER/FEVER REDUCER (NSAID)

SEE NEW WARNINGS INFORMATION

50 COATED TABLETS

INGREDIENTS AND APPEARANCE

IBUPROFEN 
ibuprofen tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-295
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	200 mg

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	115
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-295-01	1 in 1 CARTON
1		100 in 1 BOTTLE
2	NDC: 68016-295-50	1 in 1 CARTON
2		50 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA091237	05/07/2013

Labeler - Chain Drug Consortium LLC (101668460)

Registrant - Chain Drug Consortium LLC (101668460)

Establishment
Name	Address	ID/FEI	Business Operations
Marksans Pharma Limited		925822975	MANUFACTURE(68016-295)