IBUPROFEN capsule, liquid filled

IBUPROFEN by

Drug Labeling and Warnings

IBUPROFEN by is a Otc medication manufactured, distributed, or labeled by Walgreen Company, Aphena Pharma Solutions - Kentucky, LLC., Marksans Pharma Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient(s)

(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

Use(s)

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

Warnings

  Allergy alerts: 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

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
• you are taking a diuretic

Ask a doctor or pharmacist before use if

• 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
• the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stop use and ask doctor if

•  you experience any of following signs of stomach bleeding:
  • feel faint
  • vomit blood
  • have bloody or black stools
  • have stomach pain that dose not get better
• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• 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 Poison ControlCenter 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 over: take 1 capsule every 4 to 6 hours while symptoms persist
• if pain or fever dose 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 20-25 oC (68-77 oF)
• avoid excessive heat above 40 oC (104 oF)

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

Principal Display Panel

20ct_Carton

20ct_Label



 

QUESTIONS

Questions or Comments? 1-877-586-7979

INGREDIENTS AND APPEARANCE

IBUPROFEN  
ibuprofen capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-0003
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
AMMONIA (UNII: 5138Q19F1X)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
GELATIN (UNII: 2G86QN327L)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
SHELLAC (UNII: 46N107B71O)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)

Product Characteristics
Color	GREEN	Score	no score
Shape	CAPSULE	Size	19mm
Flavor		Imprint Code	133
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-0003-20	1 in 1 CARTON
1		20 in 1 BOTTLE
2	NDC: 0363-0003-40	1 in 1 CARTON
2		40 in 1 BOTTLE
3	NDC: 0363-0003-80	1 in 1 CARTON
3		80 in 1 BOTTLE
4	NDC: 0363-0003-16	1 in 1 CARTON
4		160 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA079205	05/09/2011

Labeler - Walgreen Company (008965063)

Establishment
Name	Address	ID/FEI	Business Operations
Aphena Pharma Solutions - Kentucky, LLC.		965013498	repack

Establishment
Name	Address	ID/FEI	Business Operations
Marksans Pharma Limited		925822975	manufacture