IBUPROFEN - ibuprofen tablet, coated 
Velocity Pharma

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Ibuprofen Tablets, USP 200mg

Active Ingredient

(in each tablet)

Ibuprofen 200 mg (NSAID)*

* nonsteroidal anti-inflammatory drug

Purpose

pain reliever/fever reducer

Uses

Warnings

Allergy alert: This product 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 your doctor before use if

ask your 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 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, Iron Oxide Red, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Pregelatinized Starch, Talc, Titanium Dioxide

Questions or Comments

Call toll free 1-855-314-1850

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

62377580-figure-01

62377580-figure-02

NDC: 76168-012-08 – 40 COUNT

IBUPROFEN 
ibuprofen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76168-012
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)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
STARCH, CORN (UNII: O8232NY3SJ)  
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:76168-012-0840 in 1 BOTTLE
11 in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09123907/01/2012
Labeler - Velocity Pharma (962198409)

Revised: 5/2013
Document Id: 62377580-5148-43ee-936f-0624149301d7
Set id: 83cd5cd5-94e0-4d2c-b6f9-bd1a113643ab
Version: 1
Effective Time: 20130516
 
Velocity Pharma