Available Formats

• Active ingredient (in each brown tablet)

  Ibuprofen USP,
  200 mg (NSAID)*
  *nonsteroidal anti-inflammatory drug

  ---

• Purpose

  Pain reliever/fever reducer

  ---

• Uses

  • temporarily relieves minor aches and pains due to:
    • menstrual cramps
    • toothache
    • the common cold
    • backache
    • headache
    • muscular aches
    • minor pain of arthritis
  • temporarily reduces fever

  ---

• Warnings

  Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

  • skin reddening
  • asthma (wheezing)
  • rash
  • facial swelling
  • shock
  • blisters
  • hives

  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:

  • take more or for a longer time than directed
  • take a blood thinning (anticoagulant) or steroid drug
  • are age 60 or older
  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
  • have had stomach ulcers or bleeding problems
  • have 3 or more alcoholic drinks every day while using this product

  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

  • 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
  • stomach bleeding warning applies to you
  • 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
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better
  • you have symptoms of heart problems or stroke
    • chest pain
    • trouble breathing
    • leg swelling
    • slurred speech
    • 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

  • do not take more than directed
  • the smallest effective dose should be used
  • 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

  • store between 20°-25°C (68°-77°F)
  • avoid excessive heat 40°C (104°F)
  • see end flap for expiration date and lot number

  ---

• Inactive ingredients

  carnauba wax, colloidal silicon dioxide, corn starch, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, red iron oxide, 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 RECOMMENDED‡

  NDC 0363-0291-08

  Ibuprofen

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

  24
  TABLETS

  Compare to Advil® Tablets
  active ingredient‡‡

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

  ‡ Walgreens Pharmacist Survey Study, November 2016.

  ‡‡ This product is not manufactured or distributed by Wyeth Consumer
  Healthcare, owner of the registered trademark Advil® Tablets.
  50844  REV1116A29108

  DISTRIBUTED BY: WALGREEN CO.
  200 WILMOT RD., DEERFIELD, IL 60015
  100% SATISFACTION GUARANTEED
  walgreens.com ©2017 Walgreen Co.

  

  Walgreens 44-291

  ---

• INGREDIENTS AND APPEARANCE

  IBUPROFEN  ibuprofen tablet, film coated

  Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0291 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 HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)   MAGNESIUM STEARATE (UNII: 70097M6I30)   MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)   POLYDEXTROSE (UNII: VH2XOU12IE)   POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)   STEARIC ACID (UNII: 4ELV7Z65AP)   TITANIUM DIOXIDE (UNII: 15FIX9V2JP)   CARNAUBA WAX (UNII: R12CBM0EIZ)   STARCH, CORN (UNII: O8232NY3SJ)   ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)   FERRIC OXIDE RED (UNII: 1K09F3G675)   SILICON DIOXIDE (UNII: ETJ7Z6XBU4)   SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

  Product Characteristics Color BROWN Score no score Shape ROUND Size 10mm Flavor Imprint Code 44;291 Contains

  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0291-15 1 in 1 CARTON 05/24/1988 1 50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:0363-0291-99 2 in 1 CARTON 05/24/1988 2 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 3 NDC:0363-0291-37 1 in 1 CARTON 05/24/1988 3 75 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 4 NDC:0363-0291-57 1 in 1 CARTON 05/24/1988 4 125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 5 NDC:0363-0291-12 1 in 1 CARTON 05/24/1988 5 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 6 NDC:0363-0291-14 500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/24/1988 07/08/2018 7 NDC:0363-0291-16 1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/24/1988 07/08/2018

  Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075010 05/24/1988

  Labeler - Walgreen Company (008965063)

  Establishment
  Name	Address	ID/FEI	Business Operations
  LNK International, Inc.		038154464	PACK(0363-0291)

  Establishment
  Name	Address	ID/FEI	Business Operations
  LNK International, Inc.		832867894	MANUFACTURE(0363-0291)

  Establishment
  Name	Address	ID/FEI	Business Operations
  LNK International, Inc.		967626305	PACK(0363-0291)

  Establishment
  Name	Address	ID/FEI	Business Operations
  LNK International, Inc.		832867837	PACK(0363-0291)

  Establishment
  Name	Address	ID/FEI	Business Operations
  LNK International, Inc.		868734088	PACK(0363-0291)

  ---