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

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Ibuprofen

Geri-Care Pharmaceutical Corp
Geri-Care Pharmaceutical Corp


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each brown tablet)

Ibuprofen USP, 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Ibuprofen Uses

  • Temporarily relieves minor aches and pains 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:

  • shock
  • hives
  • facial swelling
  • asthma (wheezing)
  • skin reddening
  • rash
  • blisters


Stomach bleeding warning:
  • 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

  • the 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 lasts more than 10 days
  • redness or swelling is present in the painful area
  • fever gets worse or lasts more than 3 days
  • any new symptoms occur
If pregnant or breast-feeding,

Keep out of reach of children. In case of overdose , get medical help or contact a Poison Control Center right away.

Directions

  • do not use more than directed
  • the smallest effective dose should be used
  • do not take longer than 10 days, unless directed by a doctor (see Warnings)
  • adults and children 12 years and over: 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 take more than 6 tablets in 24 hours unless directed by a doctor
  • children under 12 years: ask a doctor

Ibuprofen Other information

  • store at controlled room temperature
  • avoid excessive heat 40°C (104°F)

Inactive ingredients

carnauba wax, cellulose, corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, polydextrose, PEG, red iron oxide, sodium starch glycolate, stearic acid, titanium dioxide.

Questions or comments?

Call 1-800-540-3765

Package label



SEE NEW WARNINGS





Tamper Evident:
Ibuprofen

Ibuprofen

ibuprofen TABLET, FILM COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:57896-941
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
carnauba wax
STARCH, CORN
SILICON DIOXIDE
HYPROMELLOSES
LACTOSE
MAGNESIUM STEARATE
cellulose, microcrystalline
POLYDEXTROSE
POLYETHYLENE GLYCOLS
ferric oxide red
STEARIC ACID
SODIUM STARCH GLYCOLATE TYPE A POTATO
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
brown 10 mm 44291 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:57896-941-01 100 in 1 BOTTLE
2 NDC:57896-941-10 1000 in 1 BOTTLE
3 NDC:57896-941-05 50 in 1 BOTTLE
4 NDC:57896-941-25 250 in 1 BOTTLE
5 NDC:57896-941-50 500 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075010 2004-01-01


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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