Ibuprofen by BJWC (Berkley & Jensen / BJ's) / P & L Development, LLC DRUG FACTS

Ibuprofen by

Drug Labeling and Warnings

Ibuprofen by is a Otc medication manufactured, distributed, or labeled by BJWC (Berkley & Jensen / BJ's), P & L Development, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

IBUPROFEN- ibuprofen capsule, liquid filled 
BJWC (Berkley & Jensen / BJ's)

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DRUG FACTS

Active ingredient (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
  • backache
  • the common cold
  • minor pain of arthritis
  • toothache
  • menstrual cramps
  • muscular aches
  • 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 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 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
• the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

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
• 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

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222) 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 20 mg
• read all warnings and directions before use.
• store at 20° - 25°C (68°- 77°F)
• avoid excessive heat above 40°C (104°F). Protect from light.
• †This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Advil® Liqui-Gels®

Inactive ingredients

FD&C blue #1, gelatin, polyethylene glycol, potassium hydroxide, purified water, sorbitol

Questions or Comments ?

Call toll free 1-800-934-1204 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredient in Advil® Liqui-Gels® †

IBUPROFEN

LIQUID SOFTGELS**

Ibuprofen Capsules, 200 mg

Pain reliever/ fever reducer (NSAID)

**(LIQUID FILLED CAPSULES)

DO NOT USE IF SEAL UNDER CAP IMPRINTED WITH "SEALED for YOUR PROTECTION" IS BROKEN OR MISSING

DISTRIBUTED BY BJWC

25 RESEARCH DRIVE

WESTBOROUGH, MA 01581

PRODUCT OF USA

Product Label

Ibuprofen capsules 200 mg

IBUPROFEN 
ibuprofen capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68391-121
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
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	BLUE	Score	no score
Shape	CAPSULE	Size	19mm
Flavor		Imprint Code	A356
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68391-121-24	240 in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2012	12/31/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA202300	09/01/2012	12/31/2019

Labeler - BJWC (Berkley & Jensen / BJ's) (159082692)

Registrant - P & L Development, LLC (800014821)

Revised: 10/2018

Document Id: 0331b902-b39b-43f1-bba9-3985c4633151

34390-5

Set id: c9dbc106-1e53-47dd-8b9a-79c0ce02556f

Version: 2

Effective Time: 20181026

 

BJWC (Berkley & Jensen / BJ's)