IBUPROFEN - ibuprofen tablet 
Kinray

----------

Drug Facts

Active ingredient (in each tablet)

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

Purpose

Pain reliever/ fever reducer

Uses

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

Ask a doctor before use if

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

you experience any of the following signs of stomach bleeding:

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)

Directions

Adults and children 12 years and older
  • take 1 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, croscarmellose sodium, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide

Questions or comments? 1-877-586-7979

PRINCIPAL DISPLAY PANEL - 200 mg TABLET CARTON

Preferred Plus Pharmacy

NDC 61715-059-56

SEE NEW WARNINGS INFORMATION

*Compare to the Active Ingredient in ADVIL®

Ibuprofen TABLETS, USP 200 mg

 Pain Reliever/Fever Reducer (NSAID)

200 COATED TABLETS

Distributed By:

Kinray, Inc., Whitestone, NY 11357

(c) 2013 Kinray Inc., All Rights Reserved, PREFERRED PLUS, PREFERRED PLUS ++++ and the PREFERRED PLUS logo are trademarks and/or registered trademarks of Kinray Inc. All other marks are property of their respective owners.image description

IBUPROFEN  
ibuprofen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61715-059
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorbrownScoreno score
ShapeROUNDSize10mm
FlavorImprint Code 114
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61715-059-561 in 1 CARTON
1200 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09123907/25/2011
Labeler - Kinray (012574513)
Registrant - Aphena Pharma Solutions - Kentucky, LLC (557054835)
Establishment
NameAddressID/FEIBusiness Operations
Aphena Pharma Solutions - Kentucky, LLC557054835repack(61715-059)
Establishment
NameAddressID/FEIBusiness Operations
Marksans Pharma Limited925822975manufacture(61715-059)

Revised: 5/2013
Document Id: 24471a0d-6862-475c-9586-e78b4c6897f9
Set id: d01782d0-5019-48a2-af66-0f0c03cf95e2
Version: 2
Effective Time: 20130530
 
Kinray