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

----------

Ibuprofen Tablets, USP
Pain reliever/fever reducer (NSAID)

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 an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

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 at 20 weeks or later in 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 right away. (1-800-222-1222)

Directions

adults and children
12 years and over

  • 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, Corn Starch, Hypromellose, Iron Oxide Red, Magnesium Stearate, Microcrystalline Cellulose, Polydextrose, Polyethylene Glycol, Povidone, Sodium Lauryl Sulfate, Sodium Starch Glycolate,  Titanium Dioxide

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

Distributed By:

Amneal Pharmaceuticals LLC

Bridgewater, NJ  08807

Rev. 10-2022-02

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 53746-140-24

Ibuprofen Tablets USP, 200 mg

24 Tablets

Amneal Pharmaceuticals LLC

1

NDC 53746-143-24

Ibuprofen Tablets USP, 200 mg

24 Tablets

Amneal Pharmaceuticals LLC

1

IBUPROFEN  PAIN RELEIVER/ FEVER REDUCER
ibuprofen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53746-140
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
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 GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (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
ColorbrownScoreno score
ShapeROUNDSize10mm
FlavorImprint Code IP;140
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53746-140-2424 in 1 BOTTLE; Type 0: Not a Combination Product12/16/2009
2NDC:53746-140-01100 in 1 BOTTLE; Type 0: Not a Combination Product12/16/2009
3NDC:53746-140-101000 in 1 BOTTLE; Type 0: Not a Combination Product12/16/2009
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07133312/16/2009
IBUPROFEN  PAIN RELEIVER/ FEVER REDUCER
ibuprofen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53746-143
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
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 GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (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
ColororangeScoreno score
ShapeROUNDSize10mm
FlavorImprint Code IP;143
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53746-143-2424 in 1 BOTTLE; Type 0: Not a Combination Product12/16/2009
2NDC:53746-143-01100 in 1 BOTTLE; Type 0: Not a Combination Product12/16/2009
3NDC:53746-143-101000 in 1 BOTTLE; Type 0: Not a Combination Product12/16/2009
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07133312/16/2009
Labeler - Amneal Pharmaceuticals of New York LLC (123797875)

Revised: 12/2023
Document Id: e2b9bf54-0449-4f9b-86e8-e3b292387dd5
Set id: ee241be0-35f8-4789-a71f-98de31d6a590
Version: 16
Effective Time: 20231231
 
Amneal Pharmaceuticals of New York LLC