IBUPROFEN- ibuprofen capsule, liquid filled 
Cardinal Health (Leader) 37205

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Ibuprofen Liquid Softgels 200mg

Active ingredient (in each capsule)

Solubilized Ibuprofen equal to 200mg Ibuprofen (NSAID)*...
(present as the free acid and potassium salt)
*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

Uses

  • temporarily relieves minor aches and pains due to:
    • headache
    • muscular aches
    • minor pain of arthritis
    • toothache
    • backache
    • the common cold
    • menstrual cramps
  • temporarily reduces fever

Warnings

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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause 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 every day 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

  • the stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease,
  • you are taking a diruetic                                                                                                                              

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 doctor if

  • you experienc any of the following signs of stomach bleeding:
    • feel faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain tht oes not get better.
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • stomach pain or upset gets worse or lasts
  • 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 PoisonControlCenter right away.

Directions

  • do not take more than directed
  • the smallest effective dose should be used
  • adults and children 12 years and over:
    • take 1 capsule every 4 to 6 hours while symptoms persist
    • if pain or fever does not respond to 1 capsule, 2 capsules may be used
    • do not exceed 6 capsules in 24 hours, unless directed by a doctor
  • children under 12 years:  ask a doctor

Other Information

Other information

  • each capsule contains: potassium 20 mg
  • read all warnings and directions before use.  Keep carton.
  • store at 20-25°C (68-77°F)
  • avoid excessive heat above 40°C (104°F). Protect from light.
  • do not use if Tamper-Evident seal under bottle cap imprinted with “Sealed for Your Protection” is broken or missing                                                                                  
  • This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Advil.

Inactive Ingredients

FD&C Blue #1, gelatin, pharmaceutical ink, polyethylene glycols, potassium hydroxide, purified water, sorbitan, sorbitol

Questions or comments?

Call toll free 1-800-200-6313 Monday-Friday 9AM-5PM EST


NDC: 37205-328-58
Compare to the active ingredient in Advil (R)

SEE NEW WARNINGS INFORMATION

IBUPROFEN Liquid Softgels, 200mg

Pain Reliever/Fever Reducer (NSAID)
40 softgels (liquid filled capsules)

Product Container Label

Ibuprofen

Product Carton Label

Ibuprofen
IBUPROFEN 
ibuprofen capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-328
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN (UNII: 2G86QN327L)  
POLYETHYLENE GLYCOLs (UNII: 3WJQ0SDW1A)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
WATER (UNII: 059QF0KO0R)  
SORBITAN (UNII: 6O92ICV9RU)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorBLUE (blue) Scoreno score
ShapeOVAL (oval) Size7mm
FlavorImprint Code IBU200
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37205-328-581 in 1 BOX04/09/201212/31/2017
140 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:37205-328-5780 in 1 BOTTLE; Type 0: Not a Combination Product04/09/201212/31/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07868204/09/201212/31/2017
Labeler - Cardinal Health (Leader) 37205 (097537435)

Revised: 10/2016
 
Cardinal Health (Leader) 37205