Ibuprofen by Proficient Rx LP IBUPROFEN tablet

Ibuprofen by

Drug Labeling and Warnings

Ibuprofen by is a Otc medication manufactured, distributed, or labeled by Proficient Rx LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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®.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

IBUPROFEN 
ibuprofen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63187-139(NDC: 66424-996)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	200 mg

Inactive Ingredients
Ingredient Name	Strength
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYDEXTROSE (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	brown	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	2I
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63187-139-06	6 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2019
2	NDC: 63187-139-20	20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2019
3	NDC: 63187-139-30	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2019
4	NDC: 63187-139-60	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2019
5	NDC: 63187-139-90	90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075661	01/27/2011

Labeler - Proficient Rx LP (079196022)

Establishment
Name	Address	ID/FEI	Business Operations
Proficient Rx LP		079502574	REPACK(63187-139) , RELABEL(63187-139)