IBUPROFEN- ibuprofen tablet, film coated 
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

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 of age and overTake 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 yearsconsult a doctor

Other information

Inactive ingredients

carnuba wax, colloidal silicon dioxide, corn starch, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, red iron oxide, stearic acid, sodium starch glycolate, titanium dioxide

Questions or comments?

(866) 562-2756 Mon-Fri: 8 AM to 4 PM

PHARBEST

NDC 16103-407-11

*Compare to the active ingredient in ADVIL®

Pain Reliever/Fever Reducer (NSAID)

Ibuprofen

Tablets

200 mg

1000 Tablets

Pharbest Ibuprofen 200 mg Brown Tablet Product Label Image

IBUPROFEN 
ibuprofen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16103-407
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorbrownScoreno score
ShapeROUNDSize10mm
FlavorImprint Code 44;291
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:16103-407-061 in 1 CARTON10/01/2018
150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:16103-407-081 in 1 CARTON10/01/2018
2100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:16103-407-111000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07501010/01/2018
Labeler - Pharbest Pharmaceuticals, Inc. (557054835)
Registrant - Pharbest Pharmaceuticals, Inc. (557054835)
Establishment
NameAddressID/FEIBusiness Operations
Pharbest Pharmaceuticals, Inc.557054835relabel(16103-407) , repack(16103-407)

Revised: 10/2018
Document Id: f37e5e1c-e147-4719-85fb-dedddb00e8e6
Set id: ec19af1f-59a5-4f86-9b53-e0511df30a62
Version: 1
Effective Time: 20181001
 
Pharbest Pharmaceuticals, Inc.