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Ibuprofen by Physicians Total Care, Inc.

Dosage form: tablet
Ingredients: IBUPROFEN 200mg
Labeler: Physicians Total Care, Inc.
NDC Code: 54868-0984

Drug Facts

Active Ingredient (In each tablet)Ibuprofen 200 mg (NSAID)*
*nonsteroidal anti- inflammatory drug

PurposePain reliever/ fever reducer

Usestemporarily 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 childrenIn 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 200 mg (NSAID)*

NDC 54868-0984-4




Additional bar code label applied by:
Physicians Total Care, Inc.
Tulsa, Oklahoma      74146

IBUPROFEN 
ibuprofen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-0984(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:54868-0984-41000 TABLET (TABLET) in 1 BOTTLE, PLASTIC
2NDC:54868-0984-3100 TABLET (TABLET) in 1 BOTTLE, PLASTIC
3NDC:54868-0984-050 TABLET (TABLET) in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07566110/16/2007
Labeler - Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIOperations
Physicians Total Care, Inc.194123980relabel

Revised: 12/2011
 
Physicians Total Care, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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