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Ibuprofen by Preferred Pharmaceuticals, Inc.

Dosage form: tablet, film coated
Ingredients: IBUPROFEN 200mg
Labeler: Preferred Pharmaceuticals, Inc.
NDC Code: 68788-9133

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Major 44-291

Active ingredient (in each brown tablet)

Ibuprofen USP, 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

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

Warnings

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
 
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
 
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:
 
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
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 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.

In case of overdose, get medical help or contact a Poison Control Center ( 1-800-222-1222) 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 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
 
use by expiration date on package
 
store between 20°-25°C (68°-77°F)
 
avoid excessive heat 40°C (104°F)

Inactive ingredients

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?

(800) 616-2471

Principal Display Panel

MAJOR®

NDC 68788-9133

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

Re-order No. 700643

Repackaged By: Preferred Pharmaceuticals Inc.

Major 44-291

IBUPROFEN 
ibuprofen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-9133(NDC:0904-7915)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSE, UNSPECIFIED 
LACTOSE, UNSPECIFIED FORM 
MAGNESIUM STEARATE 
MICROCRYSTALLINE CELLULOSE 
POLYDEXTROSE 
POLYETHYLENE GLYCOL, UNSPECIFIED 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
Product Characteristics
ColorBROWNScoreno score
ShapeROUNDSize10mm
FlavorImprint Code44;291
Contains    
Packaging
#Item CodePackage Description
1NDC:68788-9133-220 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
2NDC:68788-9133-330 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
3NDC:68788-9133-550 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
4NDC:68788-9133-660 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
5NDC:68788-9133-990 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
6NDC:68788-9133-1100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34301/02/2014
Labeler - Preferred Pharmaceuticals, Inc. (791119022)
Registrant - Preferred Pharmaceuticals, Inc. (791119022)
Establishment
NameAddressID/FEIOperations
Preferred Pharmaceuticals, Inc.791119022REPACK(68788-9133)

 
Preferred Pharmaceuticals, Inc.

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Medically reviewed on Jul 26, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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