IBUPROFEN description, usages, side effects, indications, overdosage, supplying and lots more!

IBUPROFEN

Cardinal Health

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Ibuprofen Liquid Softgels 200mg

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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


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

Questions or comments?



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

Product Container Label

Product Carton Label

Product Carton Label

IBUPROFEN

IBUPROFEN CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:37205-328
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
IBUPROFEN IBUPROFEN 200 mg

Inactive Ingredients

Ingredient Name Strength
FD&C BLUE NO. 1
GELATIN
polyethylene glycol
POTASSIUM HYDROXIDE
water
SORBITAN
sorbitol

Product Characteristics

Color Size Imprint Code Shape
blue (blue) 7 mm IBU200 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 40 in 1 BOTTLE
2 NDC:37205-328-57 80 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078682 2012-04-09


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Be sure to consult your doctor before taking any medication!
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