IBUPROFEN capsule, liquid filled

IBUPROFEN by

Drug Labeling and Warnings

IBUPROFEN by is a Otc medication manufactured, distributed, or labeled by Strides Pharma Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS (IN EACH CAPSULE)

Solubilized Ibuprofen equal to 200 mg ibuprofen (NSAID)*

 (Present as the free acid and potassium salt)

*nonsteroidal anti-inflammatory drug

PURPOSE

Pain reliever/Fever reducer

USES

• Temporarily relieves minor aches and pains due to:
  • headache
  • toothache
  • backache
  • menstrual cramps
  • the common cold
  • muscular aches
  • minor pain of arthritis
• 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 aged 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 any other pain reliever/fever reducer
• right before or after heart surgery

Ask a doctor before use if

• 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, kidney disease, or asthma, or had a stroke
• you are taking a diuretic

Ask a doctor or pharmacist before use if you are

• under a doctor's care for any serious condition
• taking aspirin for 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

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 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.

OTC - 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
• 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 17.840 mg
• read all warnings and directions before use. Keep carton.
• store at 20° - 25°C (68° - 77°F)
• avoid excessive heat above 40°C (104°F)

INACTIVE INGREDIENTS

FD&C blue 1, gelatin, gelatin (hydrolyzed), medium chain triglyceride, PEG 600, potassium hydroxide, sorbital and sorbitan solution. Printing ink: white edible oil, propylene glycol, shellac resins, sodium lauryl sulphate, isopropyl alcohol, titanium dioxide.

QUESTIONS OR COMMENTS?

Call toll free number 1-877-244-9825

Code No.: KR/DRUGS/KTK/25/415/98

For most recent product information, visit us at www.stridesshasun.com

Revised: 08/2017

Manufactured by:

Strides Shasun Limited

Bengaluru – 560076, India.

Distributed by:

Strides Pharma Inc.

East Brunswick, NJ 08816

PRINCIPAL DISPLAY PANELS

Ibuprofen Capsules 200mg - 80 Soft Gel Capsules Label

Ibuprofen Capsules 200mg - 80 Soft Gel Capsules Carton

INGREDIENTS AND APPEARANCE

IBUPROFEN 
ibuprofen capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59556-764
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
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
WATER (UNII: 059QF0KO0R)
GELATIN (UNII: 2G86QN327L)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	GREEN (transparent green to bluish green)	Score	no score
Shape	OVAL (oblong shaped)	Size	8mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59556-764-13	1 in 1 CARTON	03/28/2018
1		80 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA204469	03/28/2018

Labeler - Strides Pharma Inc (078868278)

Registrant - Strides Shasun Limited (650738743)

Establishment
Name	Address	ID/FEI	Business Operations
Strides Shasun Limited		918513263	ANALYSIS(59556-764) , MANUFACTURE(59556-764) , PACK(59556-764)