IBUPROFEN- ibuprofen tablet, film coated 
WALGREEN CO.

----------

Walgreens 44-392

Active ingredient (in each orange 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

  • right before or after heart surgery
  • if you have ever had an allergic reaction to any other pain reliever/fever reducer

Ask a doctor before use if

  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have asthma
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • you are taking a diuretic
  • you have problems or serious side effects from taking pain relievers or fever reducers

Ask a doctor or pharmacist before use if you are

  • under a doctor's care for any serious condition
  • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • taking any other drug

When using this product

  • take with food or milk if stomach upset occurs
  • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed 

Stop use and ask a doctor if

  • you experience any of the following signs of stomach bleeding:
    • feel faint
    • have bloody or black stools
    • vomit blood
    • have stomach pain that does not get better
  • redness or swelling is present in the painful area
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • any new symptoms appear

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, FD&C yellow #6 aluminum lake, fumed silica gel, hypromellose, lactose, magnesium stearate, polydextrose, polyethylene glycol, sodium starch glycolate, stearic acid, titanium dioxide

Questions or Comments?

Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

Principal Display Panel

Well at
Walgreens
WALGREENS PHARMACIST RECOMMENDEDǂ

NDC 0363-0392-12

Ibuprofen 200
Ibuprofen Tablets
USP 200 mg / Pain Reliever /
Fever Reducer (NSAID)

100
TABLETS

Compare to Motrin® IB Tablets active ingredientǂǂ

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

ǂWalgreens Pharmacist Survey Study, Noevember 2010.

ǂǂThis product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Motrin® IB Tablets.

50844    ORG041139212

Walgreens 44-392

Walgreens 44-392

IBUPROFEN 
ibuprofen tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0392
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
CARNAUBA WAX (UNII: R12CBM0EIZ)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE (UNII: J2B2A4N98G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Color ORANGE Score no score
Shape ROUND Size 10mm
Flavor Imprint Code 44;392
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0363-0392-15 1 in 1 CARTON
1 50 in 1 BOTTLE; Type 0: Not a Combination Product
2 NDC:0363-0392-12 1 in 1 CARTON
2 100 in 1 BOTTLE; Type 0: Not a Combination Product
3 NDC:0363-0392-14 500 in 1 BOTTLE; Type 0: Not a Combination Product
4 NDC:0363-0392-16 1000 in 1 BOTTLE; Type 0: Not a Combination Product
5 NDC:0363-0392-17 300 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075139 03/30/2002
Labeler - WALGREEN CO. (008965063)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 038154464 PACK(0363-0392)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 832867894 MANUFACTURE(0363-0392)

Revised: 12/2014
Document Id: 4b8bf442-651a-43fa-a09b-d39d84cbc517
Set id: bc89cfaf-33e7-463b-8b72-b31877767be4
Version: 4
Effective Time: 20141209
 
WALGREEN CO.