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 Type HUMAN OTC DRUG NDC Product Code (Source) 53746-140
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 200 mg
Inactive Ingredients
Ingredient Name Strength
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
Color BROWN Score no score
Shape ROUND Size 10mm
Flavor Imprint Code IP;140
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 53746-140-24 24 TABLET In 1 BOTTLE None
2 53746-140-10 1000 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071333 12/16/2009

IBUPROFEN (NSAID)  PAIN RELEIVER/ FEVER REDUCER
ibuprofen (nsaid)   tablet
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 53746-143
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 200 mg
Inactive Ingredients
Ingredient Name Strength
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
Color ORANGE Score no score
Shape ROUND Size 10mm
Flavor Imprint Code IP;143
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 53746-143-24 24 TABLET In 1 BOTTLE None
2 53746-143-10 1000 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071333 12/16/2009

Labeler - Amneal Pharmaceuticals (831227801)
Registrant - Amneal Pharmaceuticals (831227801)
Establishment
Name Address ID/FEI Operations
Amneal Pharmaceuticals 831227801 ANALYSIS, MANUFACTURE
Revised: 05/2010 Amneal Pharmaceuticals