OTC Medication Information: Ibuprofen 200

IBUPROFEN 200- ibuprofen tablet, film coated
Walgreen Company

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 at 20 weeks or later in 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

  • 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

NDC 0363-0393-20

Walgreens
Compare to the active ingredient
in Motrin® IB Caplets††

• WALGREENS •
PHARMACIST RECOMMENDED

EASY OPEN
Ibuprofen 200

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

225
CAPLETS

ACTUAL SIZE

NOT FOR HOUSEHOLDS WITH YOUNG CHILDREN

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

50844 ORG122139320

Walgreens Pharmacist Recommended.
Our pharmacists recommend the Walgreens brand. We invite you to compare to national brands.
†† This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the
registered trademark Motrin® IB Caplets.

DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 60015 100% SATISFACTION GUARANTEED walgreens.com ©2021 Walgreen Co.

Walgreens 44-393
(click image for full-size original)

Walgreens 44-393

IBUPROFEN 200 ibuprofen tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0393
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
FD&C YELLOW NO. 6
HYPROMELLOSE, UNSPECIFIED
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYDEXTROSE
POLYETHYLENE GLYCOL, UNSPECIFIED
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
TITANIUM DIOXIDE
Product Characteristics
Color orange Score no score
Shape OVAL Size 14mm
Flavor Imprint Code 44;393
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-0393-20 225 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
2 NDC:0363-0393-15 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 (0363-0393-15)
3 NDC:0363-0393-14 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
4 NDC:0363-0393-37 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
4 75 TABLET, FILM COATED in 1 BOTTLE, PLASTIC This package is contained within the CARTON (0363-0393-37)
5 NDC:0363-0393-12 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
5 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC This package is contained within the CARTON (0363-0393-12)
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 Operations
LNK International, Inc. 038154464 pack (0363-0393)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867837 manufacture (0363-0393)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867894 manufacture (0363-0393)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 868734088 manufacture (0363-0393)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 967626305 pack (0363-0393)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 117025878 manufacture (0363-0393)

Revised: 07/2023 Walgreen Company

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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