Ibuprofen: Package Insert and Label Information

IBUPROFEN- ibuprofen tablet, film coated
Walgreen Company

Active ingredient (in each brown 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
    • muscular aches
    • minor pain of arthritis
    • backache
    • menstrual cramps
    • toothache
    • the common cold
  • temporarily reduces fever

Warnings

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

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

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
  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
  • are age 60 or older
  • 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

  • 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

  • you have a history of stomach problems, such as heartburn
  • stomach bleeding warning applies to you
  • 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
    • 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
    • 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)
  • 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

Walgreens

Compare to Advil® Caplets
active ingredient††

NDC 0363-0292-08

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

CAPLETS

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

ACTUAL SIZE

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

Walgreens Pharmacist Recommended
Walgreens Pharmacist Survey
††This product is not manufactured or distributed by Wyeth
LLC, owner of the registered trademark Advil® Caplets.

50844 ORG061829208

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

Walgreens 44-292
(click image for full-size original)

Walgreens 44-292

IBUPROFEN ibuprofen tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0292
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 200 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX
SILICON DIOXIDE
STARCH, CORN
HYPROMELLOSE, UNSPECIFIED
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYDEXTROSE
POLYETHYLENE GLYCOL, UNSPECIFIED
FERRIC OXIDE RED
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
TITANIUM DIOXIDE
Product Characteristics
Color brown Score no score
Shape OVAL Size 14mm
Flavor Imprint Code 44;292
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-0292-08 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC This package is contained within the CARTON (0363-0292-08)
2 NDC:0363-0292-15 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
2 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC This package is contained within the CARTON (0363-0292-15)
3 NDC:0363-0292-37 1 BOTTLE in 1 CARTON contains a BOTTLE
3 75 TABLET, FILM COATED in 1 BOTTLE This package is contained within the CARTON (0363-0292-37)
4 NDC:0363-0292-12 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
4 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC This package is contained within the CARTON (0363-0292-12)
5 NDC:0363-0292-17 300 TABLET, FILM COATED in 1 BOTTLE None
6 NDC:0363-0292-14 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
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 Operations
LNK International, Inc. 038154464 pack (0363-0292)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867837 manufacture (0363-0292)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867894 manufacture (0363-0292)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 967626305 pack (0363-0292)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 117025878 manufacture (0363-0292)

Revised: 01/2023 Walgreen Company

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