IBUPROFEN - ibuprofen tablet 
Kinray

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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

temporarily relieves minor aches and pain due to

temporarily reduces fever

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 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

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.

Directions

Adults and children 12 years and older
  • take one tablet every 4 to 6 hours while symptoms persists
  • 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, FD&C yellow #6 Al. lake, sodium starch glycolate, talc, titanium dioxide and triacetin.

Questions? Adverse drug event call: (866) 562-2756


PP IBUPROFEN ORANGE TABLET
IBUPROFEN  
ibuprofen tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:61715-018
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
FD&C YELLOW NO. 6  
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
TITANIUM DIOXIDE 
STARCH, CORN 
TRIACETIN 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
TALC 
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize10mm
FlavorImprint Code IBU200
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61715-018-501 in 1 CARTON
150 in 1 BOTTLE, PLASTIC
2NDC:61715-018-511 in 1 CARTON
2100 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09135511/22/2011
Labeler - Kinray (012574513)
Registrant - Pharbest Pharmaceuticals, Inc. (557054835)
Establishment
NameAddressID/FEIBusiness Operations
Pharbest Pharmaceuticals, Inc.557054835repack(61715-018), relabel(61715-018)

Revised: 3/2013
Document Id: 202ac623-305a-4005-bf14-ee5c4f276d0f
Set id: 5039de5c-a49a-4b99-9463-25f502e76534
Version: 1
Effective Time: 20130326
 
Kinray