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

IBUPROFEN

WALGREEN COMPANY

  • 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

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient(s)


(in each capsule)

200 mg ibuprofen (NSAID)*

(present as the free acid and potassium salt)

* nonsteroidal anti-inflammatory drug

Purpose


Pain reliever/Fever reducer

Use(s)

  • 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 alerts: 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 nonprescription NSAIDs [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

  • 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

  • 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 experience any of following signs of stomach bleeding:
    • feel faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain that dose not get better
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present in painful area
  • any new symptoms appear

Pregnancy/Breastfeeding


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 a 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 ControlCenter 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 over: take 1 capsule every 4 to 6 hours while symptoms persist
  • if pain or fever dose 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

  • each capsule contains: potassium 20 mg
  • read all warnings and directions before use.
  • store at 20-25 oC (68-77 oF)
  • avoid excessive heat above 40 oC (104 oF)

Inactive ingredients


 Ammonium hydroxide, FD&C green no.3, Gelatin, Iron oxide black, Medium chain triglycerides, Polyethylene glycol, Propylene glycol, Potassium hydroxide, Purified water, Shellac, Sorbitol, Sorbitan monooleate

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Questions or Comments? 1-877-586-7979

IBUPROFEN

ibuprofen CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0363-0003
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
AMMONIA
FD&C GREEN NO. 3
GELATIN
sorbitol
water
SHELLAC
SORBITAN MONOOLEATE
polyethylene glycol
propylene glycol
FERROSOFERRIC OXIDE
MEDIUM-CHAIN TRIGLYCERIDES
POTASSIUM HYDROXIDE

Product Characteristics

Color Size Imprint Code Shape
GREEN 19 mm 133 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 20 in 1 BOTTLE
2 40 in 1 BOTTLE
3 80 in 1 BOTTLE
4 160 in 1 BOTTLE
5 NDC:0363-0003-16 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079205 2011-05-09


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Be sure to consult your doctor before taking any medication!
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