Ibuprofen Tablets, USP (NSAID) Fever reducer/ Pain Reliever

IBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER - ibuprofen tablet 
Amneal Pharmaceuticals

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Ibuprofen Tablets, USP (NSAID)
Fever reducer/ Pain Reliever

Drug Facts

ACTIVE INGREDIENT

(in each 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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chances are 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 (1-800-222-1222) right away.

DIRECTIONS

Adults and children
12 years and older
  • take 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 years
  • ask a doctor

OTHER INFORMATION

INACTIVE INGREDIENTS

Brown Tablets: Anhydrous Lactose, Carnauba Wax, Colloidal Silicon Dioxide, Hypromellose, Iron Oxide Red, Magnesium Stearate, Microcrystalline Cellulose, Polydextrose, Polyethylene Glycol, Povidone, Sodium Lauryl Sulfate, Sodium Starch Glycolate, Starch (Corn), Titanium Dioxide

Orange Tablets: Anhydrous Lactose, Carnauba Wax, Colloidal Silicon Dioxide, FD&C Yellow #6, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polydextrose, Polyethylene Glycol, Povidone, Sodium Lauryl Sulfate, Sodium Starch Glycolate, Starch, Titanium Dioxide

Questions or Comments

Call 1-877-835-5472

Monday through Friday 9AM - 5PM EST.

*Amneal Pharmaceuticals is not affiliated with the owner of the trademark Motrin IB®

Distributed By:

Ameal Pharmaceuticals

Glasgow, KY 42141

Rev. 05-2010

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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IBUPROFEN (NSAID)  PAIN RELEIVER/ FEVER REDUCER
ibuprofen (nsaid)   tablet
Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)53746-140
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE 
CARNAUBA WAX 
SILICON DIOXIDE 
HYPROMELLOSE 
FERRIC OXIDE RED 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYDEXTROSE 
POLYETHYLENE GLYCOL 
POVIDONE 
SODIUM LAURYL SULFATE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STARCH, CORN 
TITANIUM DIOXIDE 
Product Characteristics
ColorBROWNScore no score
ShapeROUNDSize10mm
FlavorImprint Code IP;140
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
153746-140-2424 TABLET In 1 BOTTLENone
253746-140-101000 TABLET In 1 BOTTLENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07133312/16/2009

IBUPROFEN (NSAID)  PAIN RELEIVER/ FEVER REDUCER
ibuprofen (nsaid)   tablet
Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)53746-143
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE 
CARNAUBA WAX 
SILICON DIOXIDE 
HYPROMELLOSE 
FD&C YELLOW NO. 6 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYDEXTROSE 
POLYETHYLENE GLYCOL 
POVIDONE 
SODIUM LAURYL SULFATE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STARCH, CORN 
TITANIUM DIOXIDE 
Product Characteristics
ColorORANGEScore no score
ShapeROUNDSize10mm
FlavorImprint Code IP;143
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
153746-143-2424 TABLET In 1 BOTTLENone
253746-143-101000 TABLET In 1 BOTTLENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07133312/16/2009

Labeler - Amneal Pharmaceuticals (831227801)
Registrant - Amneal Pharmaceuticals (831227801)
Establishment
NameAddressID/FEIOperations
Amneal Pharmaceuticals831227801ANALYSIS, MANUFACTURE
Revised: 05/2010Amneal Pharmaceuticals