IBUPROFEN - ibuprofen capsule, liquid filled 
MARKSANS PHARMA LTD

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Active ingredient (in each capsule)

Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)1

(present as the free acid and potassium salt)

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1

nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/Fever reducer

Uses

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

Warnings

Allergy alert: Ibuprofen may cause a severe allergic 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 had stomach ulcers or bleeding problems
• take a blood thinning (anticoagulant) or steroid drug
• take other drugs containing an NSAID [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
• stomache problems that last or come back, such as heartburn, upset stomach, or stomach pain
• ulcers
• bleeding problems
• high blood pressure
• heart or kidney disease
• asthma
• taken a diuretic
• reached age 60 or older

Ask a doctor or pharmacist before use if you are

• taking any other drug 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 to prevent heart attack 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 a 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 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.

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 over: take 1 capsule every 4 to 6 hours while symptoms persist
• if pain or fever does not respond to 1 capsule, 2 capsules may be used
• do not exceed 6 capsules in 24 hours, unless directed by a doctor.
• children under 12 years: ask a doctor

Other information

• each capsule contains: potassium 20 mg
• read all warnings and directions before use
• store at 20 to 25°C (68 to 77°F)
• avoid excessive heat above 40°C (104°F)

Inactive ingredients Ammonium Hydroxide, FD&C Green No. 3, Gelatin, Iron oxide black, Medium chain triglycerides, Polyethylene glycol, Propylene glycol, Potassium hydroxide, Purified water, Shellac, Sorbitol, Sorbitan monooleate.

Do Not Use if seal under bottle cap imprinted with "SEALED for YOUR PROTECTION" is broken or missing.

Manufactured for:
Marksans Pharma Inc.
Lake Grove, NY 11755, USA

Manufactured by:
Marksans Pharma Ltd.
Verna,Goa - 403 722, India

Mfg. Lic. No.: GO/Drugs/515

PRINCIPAL DISPLAY PANEL - Shipping Label

NDC 25000 - 133 - 23

Ibuprofen Capsules
200 mg

(Liquid Filled Capsules)

5 x 2000 Softgels

This bulk shipment is intended for further packaging only. Content should be approved, repackaged immediately and labeled in strict conformance with the FD&C Act and regulations there under.

Material : # 131AA

CAUTION: FOR MANUFACTURING PROCESSING OR PACKAGING.

Marksans

IBUPROFEN  ibuprofen   capsule, liquid filled

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 25000-133 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IBUPROFEN (IBUPROFEN) IBUPROFEN 200 mg

Inactive Ingredients Ingredient Name Strength AMMONIA   FD&C GREEN NO. 3   GELATIN   POVIDONE   SORBITOL   WATER   FERROSOFERRIC OXIDE   SHELLAC   SORBITAN MONOOLEATE

Product Characteristics Color GREEN Score no score Shape CAPSULE Size 19mm Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 25000-133-13 1 BOTTLE In 1 BOX contains a BOTTLE 1 600 CAPSULE In 1 BOTTLE This package is contained within the BOX (25000-133-13) 2 25000-133-23 5 BAG In 1 DRUM contains a BAG 2 2000 CAPSULE In 1 BAG This package is contained within the DRUM (25000-133-23)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA079205	10/25/2009

Labeler - MARKSANS PHARMA LTD (925822975)

Establishment
Name	Address	ID/FEI	Operations
MARKSANS PHARMA LTD		925822975	MANUFACTURE

Revised: 11/2009MARKSANS PHARMA LTD