Walgreens 44-393

Walgreens 44-393

Drug Labeling and Warnings

Drug Details

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IBUPROFEN 200- ibuprofen tablet, coated 
Walgreen Company

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Walgreens 44-393

Active ingredient (in each orange caplet)

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

Purpose

Pain reliever/fever reducer

Uses

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

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

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

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

Ask a doctor before use if

  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
  • 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

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

  • do not take more than directed
  • the smallest effective dose should be used
  • adults and children 12 years and over: take 1 caplet every 4 to 6 hours while symptoms persist
  • if pain or fever does not respond to 1 caplet, 2 caplets may be used
  • do not exceed 6 caplets 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)
  • use by expiration date on package

Inactive ingredients

carnauba wax, colloidal silicon dioxide, corn starch, FD&C yellow #6 aluminum lake, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, 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

VALUE SIZE
Walgreens

Compare to Motrin® IB Caplets active ingredient††

NDC: 0363-0393-14

Ibuprofen 200

Ibuprofen USP, 200 mg /
PAIN RELIEVER/FEVER REDUCER  (NSAID)

CAPLETS

500 CAPLETS**
(**CAPSULE-SHAPED TABLETS)

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

††This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Motrin® IB Caplets.

50844  ORG061839314      ORG0618-F

DISTRIBUTED BY:
WALGREEN CO. 200 WILMOT RD.
DEERFIELD, IL 60015
100 % SATISFACTION GUARANTEED
walgreens.com ©2018 Walgreen Co.

ITEM 907105

Walgreens 44-393

Walgreens 44-393

IBUPROFEN 200 
ibuprofen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0363-0393
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
ColorORANGEScoreno score
ShapeOVALSize14mm
FlavorImprint Code 44;393
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0363-0393-121 in 1 CARTON03/01/1999
1100 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC: 0363-0393-151 in 1 CARTON03/01/1999
250 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC: 0363-0393-371 in 1 CARTON03/01/199902/07/2021
375 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC: 0363-0393-14500 in 1 BOTTLE; Type 0: Not a Combination Product03/01/1999
5NDC: 0363-0393-20225 in 1 BOTTLE; Type 0: Not a Combination Product03/01/1999
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07513903/01/1999
Labeler - Walgreen Company (008965063)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(0363-0393)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(0363-0393)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305PACK(0363-0393)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837PACK(0363-0393)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088PACK(0363-0393)

Revised: 8/2018
 
Walgreen Company


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