IBUPROFEN- ibuprofen tablet, film coated 
Pharbest Pharmaceuticals, Inc.

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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 an NSAID [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 to prevent 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.

Directions

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

Adults and children 12 years and older   
  • take one 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 20o- 25oC (68o- 77oF)
  • avoid high humidity and excessive heat above 40oC (104oF)
  • Tamper Evident: do not use if imprinted seal under the cap is broken or missing

Inactive ingredients: carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D & C yellow# 10, FD & C blue# 2, FD & C red# 40, FD & C yellow# 6, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, polysorbate 80, red iron oxide, titanium dioxide


Questions?

Adverse drug event call: (866) 562-2756

image of label

IBUPROFEN 
ibuprofen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16103-393
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
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)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorbrownScoreno score
ShapeROUNDSize10mm
FlavorImprint Code IBU200
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:16103-393-041 in 1 CARTON01/18/201105/21/2018
130 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:16103-393-061 in 1 CARTON01/18/201105/21/2018
250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:16103-393-081 in 1 CARTON01/18/201105/21/2018
3100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4NDC:16103-393-111000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/18/201105/21/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07912901/18/201105/22/2018
Labeler - Pharbest Pharmaceuticals, Inc. (557054835)
Establishment
NameAddressID/FEIBusiness Operations
Pharbest Pharmaceuticals, Inc.557054835relabel(16103-393) , repack(16103-393)

Revised: 5/2018
 
Pharbest Pharmaceuticals, Inc.