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Ibuprofen by Proficient Rx LP

Dosage form: tablet
Ingredients: IBUPROFEN 200mg
Labeler: Proficient Rx LP
NDC Code: 63187-139

Drug Facts

Active Ingredient (In each tablet)

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

Purpose

Pain reliever/ fever reducer

Uses

temporarily relieves minor aches and pain due to

minor pain of arthritis
headache
toothache
backache
the common cold
menstrual cramps
muscular aches
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 non prescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
have 3 or more alcoholic drinks everyday while using this product
take more or for a longer time 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 problems or serious side effects from taking pain relievers or fever reducers
you have a history of stomach problems, such as heartburn
you have high blood pressure, heart disease, liver cirrhosis, kidney disease or asthma
you are taking a diuretic

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 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
vomit blood
have bloody or black stools
have stomach pain that does not get better
pain gets worse or last for more than 10 days
fever gets worse or last 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.This package is not for households with young children.

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

Adults and children
12 years and older

take 1 tablet every4 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 20o- 25oC (68o- 77oF)
avoid high humidity and excessive heat above 40oC (104oF)

Inactive Ingredients:

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, DC yellow# 10, FDC blue# 2, FDC red# 40, FDC yellow# 6, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, polysorbate 80, red iron oxide, titanium dioxide

Questions? Adverse drug event call: (800)687-0176

*This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark ADVIL®.

IBUPROFEN 
ibuprofen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-139(NDC:66424-996)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
D&C YELLOW NO. 10 
FD&C BLUE NO. 2 
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYDEXTROSE 
POLYETHYLENE GLYCOLS 
POLYSORBATE 80 
FERRIC OXIDE RED 
TITANIUM DIOXIDE 
Product Characteristics
ColorbrownScoreno score
ShapeROUNDSize9mm
FlavorImprint Code2I
Contains    
Packaging
#Item CodePackage Description
1NDC:63187-139-066 TABLET in 1 BOTTLE, PLASTIC
2NDC:63187-139-2020 TABLET in 1 BOTTLE, PLASTIC
3NDC:63187-139-3030 TABLET in 1 BOTTLE, PLASTIC
4NDC:63187-139-6060 TABLET in 1 BOTTLE, PLASTIC
5NDC:63187-139-9090 TABLET in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07566101/27/2011
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIOperations
Proficient Rx LP079196022RELABEL(63187-139), REPACK(63187-139)

 
Proficient Rx LP

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Medically reviewed on Jun 6, 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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