IBUPROFEN- ibuprofen tablet 
NuCare 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:

  • 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

  • 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 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
  • 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 (1-800-222-1222).  This Package for Households Without 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
  • consult a doctor

Other information

  • Tamper Evident: do not use if safety seal under cap is broken or missing
  • store at room temperature (20 o- 25 oC) 
  • avoid excessive heat above 40 oC (104 oF)

Inactive Ingredients:

colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, red iron oxide, talc & titanium dioxide  

Questions? Adverse drug event call: (800)687-0176 Mon-Fri: 8 AM to 4 PM

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

pdp

IBUPROFEN 
ibuprofen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68071-4563(NDC:66424-396)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorbrownScoreno score
ShapeROUNDSize10mm
FlavorImprint Code 114
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68071-4563-330 in 1 BOTTLE; Type 0: Not a Combination Product09/17/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09123903/01/201612/31/2020
Labeler - NuCare Pharmaceuticals,Inc. (010632300)
Establishment
NameAddressID/FEIBusiness Operations
NuCare Pharmaceuticals,Inc.010632300repack(68071-4563)

Revised: 6/2024
 
NuCare Pharmaceuticals,Inc.