IBUPROFEN- ibuprofen tablet, film coated 
Rebel Distributors Corp

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Ibuprofen

Active ingredient (in each brown tablet)

Ibuprofen USP, 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

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

carnauba wax, cellulose, corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, polydextrose, PEG, red iron oxide, sodium starch glycolate, stearic acid, titanium dioxide.

Questions or comments?

Call 1-800-540-3765

Package label

Ibuprofen 200mg

SEE NEW WARNINGS

IBUPROFEN

pain reliever/fever reducer (NSAID)

COMPARE TO THE ACTIVE INGREDIENT IN ADVIL*

100 Tablets

200 mg each

Tamper Evident:

Do not use if imprinted seal under cap is missing or broken.

IBUPROFEN 
ibuprofen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42254-315(NDC:57896-941)
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)  
STARCH, CORN (UNII: O8232NY3SJ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE (UNII: J2B2A4N98G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POLYETHYLENE GLYCOLS (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 44291
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42254-315-2020 in 1 BOTTLE
2NDC:42254-315-2828 in 1 BOTTLE
3NDC:42254-315-3030 in 1 BOTTLE
4NDC:42254-315-4040 in 1 BOTTLE
5NDC:42254-315-5050 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07501001/01/2004
Labeler - Rebel Distributors Corp (118802834)
Registrant - PSS World Medical, Inc. (101822862)
Establishment
NameAddressID/FEIBusiness Operations
PSS World Medical, Inc.791528623REPACK(42254-315)
Establishment
NameAddressID/FEIBusiness Operations
STAT RX USA LLC786036330REPACK(42254-315)
Establishment
NameAddressID/FEIBusiness Operations
Dispensing Solutions, Inc.066070785RELABEL(42254-315) , REPACK(42254-315)
Establishment
NameAddressID/FEIBusiness Operations
SCRIPT PAK964420108RELABEL(42254-315) , REPACK(42254-315)
Establishment
NameAddressID/FEIBusiness Operations
Keltman Pharmaceuticals, Inc.362861077REPACK(42254-315)
Establishment
NameAddressID/FEIBusiness Operations
Rebel Distirbutors Corp.118802834RELABEL(42254-315) , REPACK(42254-315)

Revised: 10/2012
Document Id: c9d22362-e442-4690-9aa9-9d34aef09504
Set id: c9d22362-e442-4690-9aa9-9d34aef09504
Version: 1
Effective Time: 20121016
 
Rebel Distributors Corp