PREFERRED PLUS IBUPROFEN 200  - ibuprofen tablet 
Kinray

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DRUG FACTS

Active ingredient

Ibuprofen 200 mg (NSAID)1

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1nonsteroidal 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

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

Other Information

Inactive Ingredients  

colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl celluose, hypromellose, microcrystalline

celluose, pregelatinized starch, stearic acid, titanium dioxide

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PREFERRED PLUS IBUPROFEN 200  
ibuprofen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61715-053
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)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorbrownScoreno score
ShapeROUNDSize10mm
FlavorImprint Code IBU200
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61715-053-088 in 1 BLISTER PACK
2NDC:61715-053-011 in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34306/26/2013
Labeler - Kinray (012574513)
Registrant - Reese Pharmaceutical Co (004172052)
Establishment
NameAddressID/FEIBusiness Operations
Reese Pharmaceutical Co004172052relabel(61715-053) , repack(61715-053)
Establishment
NameAddressID/FEIBusiness Operations
Pharbest557054835manufacture(61715-053)

Revised: 6/2013
Document Id: 08db7699-e25d-4d10-9d06-e0b2435a3149
Set id: 6cd086b5-9e71-4f1f-8c47-1d8f50481a92
Version: 1
Effective Time: 20130626
 
Kinray