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ibuprofen

Walgreen Co. Ibuprofen Drug Facts

Approved
Approval ID

37c9b887-190a-4daf-8199-f406913132f0

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 3, 2025

Manufacturers
FDA

Walgreen Company

DUNS: 008965063

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Ibuprofen

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0363-0604
Application NumberANDA072096
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ibuprofen
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 3, 2025
FDA Product Classification

INGREDIENTS (12)

IBUPROFENActive
Quantity: 200 mg in 1 1
Code: WK2XYI10QM
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/3/2025

Principal Display Panel

Walgreens

WALGREENS PHARMACIST RECOMMENDED

Compare to the active ingredient in Advil® Tablets

Ibuprofen

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

100 TABLETS

ACTUAL SIZE

![walgreens-ibuprofen-carton-image.jpg](/dailymed/image.cfm?name=walgreens- ibuprofen-carton-image.jpg&id=897164)

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 11/8/2017

Uses

temporarily relieves minor aches and pains due to:

headache

muscular aches

minor pain of arthritis

toothache

backache

the common cold

menstrual cramps

temporarily reduces fever

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/27/2009

Active ingredient (in each tablet)

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/28/2021

Purposes

Pain reliever/fever reducer

WARNINGS SECTION

LOINC: 34071-1Updated: 9/3/2025

Warnings

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

hives

facial swelling

asthma (wheezing)

shock

skin reddening

rash

blisters

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

are age 60 or older

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]

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 ibuprofen or any other pain reliever/fever reducer

right before or after heart surgery

Ask a doctor before use if

you have problems or serious side effects from taking pain relievers or fever reducers

the 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

Ask a doctor or pharmacist before use if you are

taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin

under a doctor’s care for any serious condition

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

weakness in one part or side of the body

slurred speech

leg swelling

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 (1-800-222-1222).

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/3/2025

Directions

**do not take more than directed**

**the smallest effective dose should be used**  

adults and children 12 years and older

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

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 9/3/2025

Other information

read all warnings and directions before use

store between 20-25°C (68-77°F)

avoid high humidity and excessive heat above 40°C (104°F)

see end panel for lot number and expiration date

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/27/2009

Inactive ingredients

colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow, microcrystalline cellulose, polyethylene glycol, polysorbate 80, stearic acid, titanium dioxide

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/28/2021

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ibuprofen - FDA Drug Approval Details