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

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Ibuprofen

Kinray
Pharbest Pharmaceuticals, Inc.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredient (In each tablet)

Ibuprofen 200 mg (NSAID)*
*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/ fever reducer

Ibuprofen Uses

temporarily relieves minor aches and pain due to

  • minor pain of arthritis
  • headache
  • toothache
  • backache
  • the common cold
  • menstrual cramps
  • muscular aches

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 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 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 to prevent 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.

Directions

  • do not take more than directed
  • the smallest effective dose should be used
Adults and children 12 years and older
  • take one tablet every 4 to 6 hours while symptoms persists
  • 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
  • ask a doctor

Other Information

  • store between 20o- 25oC (68o- 77oF)
  • avoid high humidity and excessive heat above 40oC (104oF)
  • Tamper Evident: do not use if the imprinted seal under the cap is broken or missing

Inactive Ingredients:

colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, FD&C yellow #6 Al. lake, sodium starch glycolate, talc, titanium dioxide and triacetin.

Questions? Adverse drug event call: (866) 562-2756


Ibuprofen

Ibuprofen

Ibuprofen TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:61715-018
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
SILICON DIOXIDE
FD&C YELLOW NO. 6
HYPROMELLOSES
MAGNESIUM STEARATE
cellulose, microcrystalline
titanium dioxide
STARCH, CORN
triacetin
SODIUM STARCH GLYCOLATE TYPE A POTATO
talc

Product Characteristics

Color Size Imprint Code Shape
orange 10 mm IBU200 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 50 in 1 BOTTLE, PLASTIC
2 100 in 1 BOTTLE, PLASTIC
3 NDC:61715-018-51 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091355 2011-11-22


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Be sure to consult your doctor before taking any medication!
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