MedPath

Dye Free Ibuprofen

Walgreens 44-438-Motrin

Approved
Approval ID

8944a0e8-2928-4494-915f-d1e0a6d4bf5c

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 26, 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 Code0363-4381
Application NumberANDA075139
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ibuprofen
Product Specifications
Route of AdministrationORAL
Effective DateAugust 26, 2025
FDA Product Classification

INGREDIENTS (13)

IBUPROFENActive
Quantity: 200 mg in 1 1
Code: WK2XYI10QM
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/26/2025

Principal Display Panel

Walgreens
****WALGREENS PHARMACIST RECOMMENDED†

Compare to the active ingredient
in Motrin® IB Tablets††

NDC 0363-4381-12

Dye-Free
** Ibuprofen 200**
****IBUPROFEN TABLETS USP, 200 MG
PAIN RELIEVER / FEVER REDUCER
(NSAID)

100
****TABLETS

ACTUAL SIZE

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

DISTRIBUTED BY:WALGREEN CO.
DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
walgreens.com ©2024 Walgreen Co.

†Our pharmacists recommend the Walgreens brand.
We invite you to compare to national brands.
††This product is not manufactured or distributed by
Kenvue Inc., owner of the registered trademark
Motrin® IB Tablets.

50844 ORG122143812

Walgreens 44-438

Walgreens 44-438

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/26/2025

Uses

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

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 8/26/2025

Questions or comments?

Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/26/2025

Active ingredient (in each white tablet)

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

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/26/2025

Purpose

Pain reliever/fever reducer

WARNINGS SECTION

LOINC: 34071-1Updated: 8/26/2025

Warnings

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

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

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

**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 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
    • 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.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/26/2025

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

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 8/26/2025

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 INGREDIENT SECTION

LOINC: 51727-6Updated: 8/26/2025

Inactive ingredients

colloidal silicon dioxide, corn starch, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium starch glycolate, stearic acid, triacetin

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Dye Free Ibuprofen - FDA Drug Approval Details