IBUPROFEN- ibuprofen tablet, film coated 
Major Pharmaceuticals

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Major Pharmaceuticals Ibuprofen Drug Facts

Active ingredient (in each tablet)

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

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

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 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).

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

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)

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

Questions or comments?

1-800-616-2471

Principal Display Panel

MAJOR®

SEE REVISED WARNING

Ibuprofen Tablets, 200 mg

PAIN RELIEVER

FEVER REDUCER

(NSAID)

COMPARE TO the active ingredient of ADVIL®

Actual Size

1000 COATED TABLETS

604-5c-ibuprofen
IBUPROFEN 
ibuprofen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6747
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorBROWNScoreno score
ShapeROUNDSize10mm
FlavorImprint Code I2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-6747-511 in 1 CARTON09/20/2018
150 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:0904-6747-591 in 1 CARTON09/20/2018
2100 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:0904-6747-701 in 1 CARTON09/20/2018
3250 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:0904-6747-40500 in 1 BOTTLE; Type 0: Not a Combination Product09/20/2018
5NDC:0904-6747-801000 in 1 BOTTLE; Type 0: Not a Combination Product09/20/2018
6NDC:0904-6747-241 in 1 CARTON09/20/2018
624 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07209609/20/2018
Labeler - Major Pharmaceuticals (191427277)

Revised: 6/2023
Document Id: f095763a-fa57-4c89-92fb-1e0674233f44
Set id: 14f43c32-0895-4ef2-aa54-52b952d058fd
Version: 4
Effective Time: 20230614
 
Major Pharmaceuticals