IBUPROFEN PAIN RELEIVER/ FEVER REDUCER- ibuprofen tablet 
Amneal Pharmaceuticals of New York, LLC

----------

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

ACTIVE INGREDIENT

(in each tablet)

Ibuprofen USP, 200 mg (NSAID)**

**nonsteroidal anti-inflammatory drug

PURPOSE

Pain reliever/fever reducer

INDICATIONS AND USAGE

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:

OTC - DO NOT USE

Do not use

OTC - ASK DOCTOR

Ask a doctor before use if

OTC - ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are

OTC - WHEN USING

When using this product

OTC - STOP USE

Stop use and ask a doctor if

PREGNANCY OR BREAST FEEDING

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

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.

DOSAGE AND ADMINISTRATION

   
 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

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 Advil®

Distributed By:

Ameal Pharmaceuticals

Glasgow, KY 42141

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

23093acd-figure-01
23093acd-figure-02
IBUPROFEN  PAIN RELEIVER/ FEVER REDUCER
ibuprofen tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:53746-140
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POVIDONES (UNII: FZ989GH94E)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STARCH, CORN (UNII: O8232NY3SJ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Color BROWN Score no score
Shape ROUND Size 10mm
Flavor Imprint Code IP;140
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:53746-140-24 24 in 1 BOTTLE
2 NDC:53746-140-01 100 in 1 BOTTLE
3 NDC:53746-140-10 1000 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071333 12/16/2009
IBUPROFEN  PAIN RELEIVER/ FEVER REDUCER
ibuprofen tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:53746-143
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POVIDONES (UNII: FZ989GH94E)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STARCH, CORN (UNII: O8232NY3SJ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Color ORANGE Score no score
Shape ROUND Size 10mm
Flavor Imprint Code IP;143
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:53746-143-24 24 in 1 BOTTLE
2 NDC:53746-143-01 100 in 1 BOTTLE
3 NDC:53746-143-10 1000 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071333 12/16/2009
Labeler - Amneal Pharmaceuticals of New York, LLC (123797875)
Establishment
Name Address ID/FEI Business Operations
Amneal Pharmaceuticals of New York, LLC 831227801 ANALYSIS(53746-140, 53746-143) , LABEL(53746-140, 53746-143) , MANUFACTURE(53746-140, 53746-143) , PACK(53746-140, 53746-143) , REPACK(53746-140, 53746-143)

Revised: 6/2014
Document Id: 2d202e25-8db1-4a89-baf9-194ce169ebe0
Set id: ee241be0-35f8-4789-a71f-98de31d6a590
Version: 12
Effective Time: 20140626
 
Amneal Pharmaceuticals of New York, LLC