PREFERRED PLUS IBUPROFEN- ibuprofen tablet, film coated

Preferred Plus Ibuprofen by

Drug Labeling and Warnings

Preferred Plus Ibuprofen by is a Otc medication manufactured, distributed, or labeled by Kinray, Inc., Pharbest Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient (in each tablet)

Ibuprofen 200 mg (NSAID)*
*nonsteroidal anti- inflammatory drug

Purpose

Pain Reliever/ Fever Reducer

Uses

• temporarily relieves minor aches and pain due to

- minor pain of arthritis
- headache
- toothache
- backache
- the common cold
- 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 an NSAID [aspirin, ibuprofen, naproxen, or others]
• have 3 or more alcoholic drinks everyday 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 to prevent heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
• taking any other drug

when using this product

• take 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 last for more than 10 days
• fever gets worse or last 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 or pregnancy unless 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

• Adults and children 12 years and older:
  • take one tablet every 4 to 6 hours while symptoms persist
  • if pain or fever does not respond to 1 tablet, 2 tablets may be used
  • do not exceed 6 tablets in 24 hours, unless directed by a doctor;
• children under 12 years:
  • ask a doctor;

other information

• store between 20o- 25oC (68o- 77oF)
• avoid high humidity and excessive heat above 40oC (104oF)
• Tamper Evident: do not use if imprinted seal under the cap is broken or missing
  

Inactive ingredients

colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, red iron oxide, sodium starch glycolate, titanium dioxide and triacetin.

Questions?

Adverse drug event call: (866) 562-2756

Principal Display Panel

Ibuprofen Tablets 200 mg

*Compare to the active ingredient in ADVIL®.

See New Warnings Information

Pain Reliever/Fever Reducer (NSAID)

KEEP OUTER CARTON FOR COMPLETE WARNING AND PRODUCT INFORMATION

All Preferred Plus Pharmacy products are satisfaction guaranteed or your money back from retailer where purchased.

*This product is not manufactured or distributed by Pfizer Consumer Products, owner of the registered trademark ADVIL®. 

Distributed By: Kinray, Inc.

Whitestone, NY 11357

©2013 Kinray, Inc.,All rights reserved, PREFERRED PLUS, PREFERRED PLUS ++++ and the PREFERRED PLUS logo are trademarks of Kinray, Inc. All other marks are property of their respective owners.

Product Label

INGREDIENTS AND APPEARANCE

PREFERRED PLUS IBUPROFEN  
ibuprofen tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61715-057
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
TRIACETIN (UNII: XHX3C3X673)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	brown	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	IBU200
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61715-057-50	1 in 1 CARTON
1		50 in 1 BOTTLE, PLASTIC
2	NDC: 61715-057-51	1 in 1 CARTON
2		100 in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA079129	05/11/2013

Labeler - Kinray, Inc. (012574513)

Registrant - Pharbest Pharmaceuticals, Inc. (557054835)

Establishment
Name	Address	ID/FEI	Business Operations
Pharbest Pharmaceuticals, Inc.		557054835	repack(61715-057) , relabel(61715-057)