FDA.reportPublic FDA data

Ibuprofen

Manufacturer
Preferred Pharmaceuticals Inc.
Effective date
2021-06-02
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 22:44:05

Label at a glance#

ProductIbuprofen
Active ingredientIBUPROFEN
Label structure9 sections

Indications and uses

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

Dosage and administration

  do not take more than directed   the smallest effective dose should be used 1. 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

  use by expiration date on package   store between 20°-25°C (68°-77°F)   avoid excessive heat 40°C (104°F)

Label contents#

Full prescribing information#

Active ingredient (in each brown tablet)

OTC - ACTIVE INGREDIENT SECTION

Ibuprofen USP, 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

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

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
  • are age 60 or older
  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
  • take a blood thinning (anticoagulant) or steroid drug
  • 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

OTC - DO NOT USE SECTION

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

  • 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

OTC - WHEN USING SECTION

  • take with food or milk if stomach upset occurs

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you experience any of the following signs of stomach bleeding:
  • have bloody or black stools
    • vomit blood
  • feel faint
  • have stomach pain that does not get better
  • you have symptoms of heart problems or stroke
    1. chest pain
    2. slurred speech
    3. leg swelling
    4. trouble breathing
    5. 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center ( 1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed
  • the smallest effective dose should be used
  1. adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persist
  2. if pain or fever does not respond to 1 tablet, 2 tablets may be used
  3. do not exceed 6 tablets in 24 hours, unless directed by a doctor
  4. children under 12 years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • use by expiration date on package
  • store between 20°-25°C (68°-77°F)
  • avoid excessive heat 40°C (104°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

(800) 616-2471

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAJOR®

NDC 68788-6459

Compare to the active ingredient in Advil® Tablets†

Ibuprofen
Tablets
Ibuprofen Tablets, USP 200 mg

Pain Reliever
Fever Reducer (NSAID)

COATED TABLETS

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

50844        REV1116E29116

Distributed by
MAJOR PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152 USA      M-17        Rev.09/17

Repackaged By: Preferred Pharmaceuticals Inc.

Major 44-291
Major 44-291

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7915-24EA - Each0904-79150ebdac4b-1423-4631-bd60-3aa7a719617012013-02-13
0904-7915-40EA - Each0904-7915c84dc8bb-62dd-4b45-a91f-796d05fd602712013-02-13
0904-7915-51EA - Each0904-79153fe69536-1766-4963-acb3-21a88838668812013-02-13
0904-7915-59EA - Each0904-7915e3a622d9-4151-4d28-bb86-3432d0d0809f12013-02-13
0904-7915-70EA - Each0904-7915c84e7340-52bf-4996-9009-03bc868e8be912013-02-13
0904-7915-80EA - Each0904-791509add50d-10b5-4ab8-97f7-db45326bb4e912013-02-11

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68788-645968788-6459-2, 68788-6459-3, 68788-6459-5, 68788-6459-6, 68788-6459-9, 68788-6459-1, 68788-6459-4
0904-7915

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
IBUPROFENWK2XYI10QMACTIB
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYDEXTROSEVH2XOU12IEIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
STEARIC ACID4ELV7Z65APIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
81364ed4-64b7-4441-add6-274604979268cb1331d9-b530-4d33-a656-c01f5c6f74112022-11-14WarningsExact identifier
spl set id: cb1331d9-b530-4d33-a656-c01f5c6f7411

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.