IBUPROFEN- ibuprofen tablet 
Pharbest Pharmaceuticals, 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

temporarily relieves minor aches and pain due to:

Warnings


Allergy alert:

Ibuprofen may cause a severe allergic reaction, especially in people allergic to Aspirin. Symptoms may include

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock
  • skin reddening
  • rash
  • blisters

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

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or non prescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcoholic drinks everyday while using this product
  • take more or for a longer time than directed

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 (1-800-222-1222). This Package for Households Without Young Children.

Directions

adults and children
12 years and older
  • take 1 tablet every4 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
  • consult a doctor

Other information

Inactive Ingredients:

colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, red iron oxide, talc & titanium dioxide  

Questions? Adverse drug event call: (866)562-2756 Mon-Fri: 8 AM to 4 PM

*This product is not manufactured or distributed by Pfizer Consumer Products, owner of the registered trademark ADVIL®.

Manufactured for:

Pharbest Pharmaceuticals, Inc.,

Farmingdale, NY 11735

LRev 02/16

NDC 16103-0396-11

PHARBEST

*Compare to the active ingredient in Advil®

Pain Reliever / Fever Reducer (NSAID)

IBUPROFEN

Tablets

200mg

1000 Tablets

Pharbest Ibuprofen 200 mg Brown Tablet Product Label

IBUPROFEN 
ibuprofen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16103-396
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)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
STARCH, CORN (UNII: O8232NY3SJ)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
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:16103-396-111000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/2016
2NDC:16103-396-081 in 1 CARTON03/01/2016
2100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:16103-396-061 in 1 CARTON03/01/2016
350 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4NDC:16103-396-041 in 1 CARTON03/01/2016
430 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09123903/01/2016
Labeler - Pharbest Pharmaceuticals, Inc. (557054835)
Registrant - Pharbest Pharmaceuticals, Inc. (557054835)
Establishment
NameAddressID/FEIBusiness Operations
Pharbest Pharmaceuticals, Inc.557054835repack(16103-396) , relabel(16103-396)

Revised: 5/2018
Document Id: b930519b-3c6f-4f19-8e84-227c44b06331
Set id: 5ebcd4d3-0397-4061-be0f-7e50b9d1780d
Version: 1
Effective Time: 20180519
 
Pharbest Pharmaceuticals, Inc.