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Ibuprofen by Kinray, Inc.

Medically reviewed on March 1, 2018

Dosage form: tablet
Ingredients: IBUPROFEN 200mg
Labeler: Kinray, Inc.
NDC Code: 61715-168

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). 

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

adults and children
12 years and older
  • take 1 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
  • consult a doctor

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

Inactive Ingredients:

colloidal silicon dioxide, croscarmellose sodium, FD&C Yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc & titanium dioxide  

Questions? Adverse drug event call: (866)562-2756 Mon-Fri: 8 AM to 4 PM

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark MOTRIN® IB.

NDC 61715-168-50

*Compare to the active ingredient in MOTRIN® IB.

Preferred plus Pharmacy

IBUPROFEN 

Tablets  USP 200mg

Pain Reliever / Fever Reducer (NSAID)

50 Tablets

IBUPROFEN 
ibuprofen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61715-168
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
FD&C YELLOW NO. 6 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 3350 
POLYVINYL ALCOHOL 
STARCH, PREGELATINIZED CORN 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize10mm
FlavorImprint Code115
Contains    
Packaging
#Item CodePackage Description
1NDC:61715-168-501 BOTTLE, PLASTIC in 1 CARTON
150 TABLET in 1 BOTTLE, PLASTIC
2NDC:61715-168-511 BOTTLE, PLASTIC in 1 CARTON
2100 TABLET in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09123703/01/2016
Labeler - Kinray, Inc. (012574513)
Registrant - Pharbest Pharmaceuticals, Inc. (557054835)
Establishment
NameAddressID/FEIOperations
Pharbest Pharmaceuticals, Inc.557054835repack(61715-168), relabel(61715-168)

 
Kinray, Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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