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Ibuprofen by Proficient Rx LP

Medically reviewed on July 3, 2017

Dosage form: tablet, film coated
Ingredients: IBUPROFEN 200mg
Labeler: Proficient Rx LP
NDC Code: 63187-598

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.

Rite Aid 44-329

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:
 
headache
 
toothache
 
backache
 
menstrual cramps
 
the common cold
 
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:

 
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:

 
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

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, or kidney disease
 
you are taking a diuretic
 
you have asthma
 
you have problems or serious side effects from taking pain relievers or fever reducers

Ask a doctor or pharmacist before use if you are
taking any other drug
taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
under a doctor"s care for any serious condition

When using this product
 
take with food or milk if stomach upset occurs
 
the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

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
 
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 right away.

Directions
 
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

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

Inactive ingredients

carnauba wax, corn starch, fumed silica gel, hypromellose, lactose, 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 63187-598-30

†Compare to the active ingredient in Advil® Tablets

Ibuprofen
Tablets
Ibuprofen Tablets, USP 200 mg

Pain Reliever
Fever Reducer (NSAID)

50 COATED TABLETS

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

50844        REV0112D29116

Distributed by
MAJOR PHARMACEUTICALS
31778 Enterprise Drive
Livonia, MI 48150 USA      M-17        Rev.01/13

Repackaged by:

Proficient Rx LP

Thousand Oaks, CA 91320

Re-order No. 700643

Major 44-291

IBUPROFEN 
ibuprofen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-598(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 
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:63187-598-0606 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
2NDC:63187-598-3030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
3NDC:63187-598-4040 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
4NDC:63187-598-5050 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
5NDC:63187-598-6060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
6NDC:63187-598-9090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34305/24/1988
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIOperations
Proficient Rx LP079502574REPACK(63187-598), RELABEL(63187-598)

 
Proficient Rx LP

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Further information

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

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