Ibuprofen by Polygen Pharmaceuticals LLC / Marksans Pharma Limited IBUPROFEN tablet

Ibuprofen by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT(S)

(each Caplet contains)

Ibuprofen 200 mg (NSAID)*

·        Non-steroidal 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 containing an NSAID (prescription or nonprescription)
• taking a blood thinning (anticoagulant) or steroid 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 caplet every 4 to 6 hours while symptoms persist
  • if pain or fever does not respond to 1 caplet, 2 caplets may be used
  • do not exceed 6 caplets in 24 hours, unless directed by a doctor.
• Children under 12 years:
  • ask a doctor

STORAGE

• Store between 20-250C (68-770F).
• do not use if seal under bottle cap is broken or missing.

INACTIVE INGREDIENTS

Microcrystalline Cellulose, Croscarmellose Sodium, Pregelatinized starch, talc, Colloidal silicon dioxide, Magnesium stearate,polyvinyl Alcohol, Polyethylene glycol,Titanium dioxide.

PRINCIPAL DISPLAY PANEL

Carton Label
Thrulife
NDC : 52605-120-01
IBUPROFEN TABLETS, 200 mg
PAIN RELIEVER/ FEVER REDUCER (NSAID)
100 COATED CAPLETS
CAPSULE SHAPED TABLETS






Bottle label PDP
Thrulife
NDC: 52605-120-01
IBUPROFEN TABLETS USP, 200 mg
PAIN RELIEVER/ FEVER REDUCER (NSAID)
100 COATED CAPLETS
CAPSULE SHAPED TABLETS

INGREDIENTS AND APPEARANCE

IBUPROFEN 
ibuprofen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52605-120
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)
TALC (UNII: 7SEV7J4R1U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, CORN (UNII: O8232NY3SJ)
COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL (UNII: 532B59J990)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score	no score
Shape	CAPSULE	Size	15mm
Flavor		Imprint Code	120
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52605-120-01	1 in 1 CARTON
1		100 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA091237	07/02/2013

Labeler - Polygen Pharmaceuticals LLC (962415720)

Registrant - Polygen Pharmaceuticals LLC (962415720)

Establishment
Name	Address	ID/FEI	Business Operations
Marksans Pharma Limited		925822975	MANUFACTURE(52605-120)