DYE FREE IBUPROFEN- ibuprofen tablet 
Walgreen Company

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Walgreens 44-438-ADR

Active ingredient (in each white 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

  • 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 are taking a diuretic
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
  • 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

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
  • you have symptoms of heart problems or stroke
  • chest pain 
  • slurred speech
  • leg swelling
  • trouble breathing
  • weakness in one part or side of body
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present in the painful area
  • 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 (1-800-222-1222) right away.

Directions

Other information

Inactive ingredients

corn starch, colloidal silicon dioxide, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium starch glycolate, stearic acid, triacetin 

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 0363-0438-99

Dye-Free
Ibuprofen

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

100 TABLETS

DYE FREE

Compare to Advil® Tablets active ingredientǂǂ

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

ǂWalgreens Pharmacist Survey Study, November 2016.
ǂǂThis product is not manufactured or distributed by Wyeth Consumer Healthcare, owner of the registered trademark Advil® Tablets.

50844         REV1116B43812

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200 WILMOT RD., DEERFIELD, IL 60015
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Walgreens 44-438

Walgreens 44-438


DYE FREE IBUPROFEN 
ibuprofen tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0438
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES (UNII: 3NXW29V3WO)  
TRIACETIN (UNII: XHX3C3X673)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
STARCH, CORN (UNII: O8232NY3SJ)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 10mm
Flavor Imprint Code 44;438
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0363-0438-12 1 in 1 CARTON 03/01/1999 04/07/2019
1 100 in 1 BOTTLE; Type 0: Not a Combination Product
2 NDC:0363-0438-15 1 in 1 CARTON 03/01/1999 10/08/2016
2 50 in 1 BOTTLE; Type 0: Not a Combination Product
3 NDC:0363-0438-99 1 in 1 CARTON 03/01/1999
3 100 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 03/01/1999
Labeler - Walgreen Company (008965063)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 038154464 PACK(0363-0438)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 832867894 MANUFACTURE(0363-0438)

Revised: 4/2017
Document Id: 63ee52c2-bdcd-46ba-baf2-e9654bdbeca0
Set id: d3d093f9-207a-40d4-a7be-c6b5a544a0a7
Version: 5
Effective Time: 20170420
 
Walgreen Company