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 Type HUMAN OTC DRUG Item Code (Source) NDC:61715-018
Route of Administration ORAL DEA Schedule     
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)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
STARCH, CORN (UNII: O8232NY3SJ)  
TRIACETIN (UNII: XHX3C3X673)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
Color orange 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:61715-018-50 1 in 1 CARTON
1 50 in 1 BOTTLE, PLASTIC
2 NDC:61715-018-51 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 ANDA091355 11/22/2011
Labeler - Kinray (012574513)
Registrant - Pharbest Pharmaceuticals, Inc. (557054835)
Establishment
Name Address ID/FEI Business Operations
Pharbest Pharmaceuticals, Inc. 557054835 repack(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