PREFERRED PLUS IBUPROFEN  - ibuprofen tablet, film coated 
Kinray, Inc.

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Drug Facts

Active Ingredient (in each tablet)

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

Purpose

Pain Reliever/ Fever Reducer

Uses

- minor pain of arthritis
- headache
- toothache
- backache
- the common cold
- menstrual cramps
- muscular aches

Warnings

Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include

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

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


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

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

P.P. Ibuprofen Carton Image

PREFERRED PLUS IBUPROFEN  
ibuprofen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61715-057
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorbrownScoreno score
ShapeROUNDSize10mm
FlavorImprint Code IBU200
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61715-057-501 in 1 CARTON
150 in 1 BOTTLE, PLASTIC
2NDC:61715-057-511 in 1 CARTON
2100 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07912905/11/2013
Labeler - Kinray, Inc. (012574513)
Registrant - Pharbest Pharmaceuticals, Inc. (557054835)
Establishment
NameAddressID/FEIBusiness Operations
Pharbest Pharmaceuticals, Inc.557054835repack(61715-057) , relabel(61715-057)

Revised: 5/2013
Document Id: 28835a86-b0f8-400e-9c26-cd077955d640
Set id: 190deb85-92e2-4904-9e69-df0dd3b6be40
Version: 1
Effective Time: 20130511
 
Kinray, Inc.