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

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Ibuprofen

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

BOXED WARNING


  • ●NSAIDs may cause an increased risk of serious cardiovascularthrombotic events, myocardial infarction, and stroke,which can be fatal. This risk may increase with duration ofuse. Patients with cardiovascular disease or risk factors forcardiovascular disease may be at greater risk (SeeWARNINGS).
  • ●IBU tablets are contraindicated for treatment of peri-operativepain in the setting of coronary artery bypass graft (CABG)surgery (SeeWARNINGS).
  • ●Gastrointestinal Risk
  • ●NSAIDS cause an increased risk of serious gastrointestinaladverse events including bleeding, ulceration, and perforationof the stomach or intestines, which can be fatal. These eventscan occur at any time during use and without warning symptoms.Elderly patients are at greater risk for serious gastrointestinalevents. (SeeWARNINGS).

IBUPROFEN DESCRIPTION



Ibuprofen




CLINICAL PHARMACOLOGY


ADVERSE REACTIONS

ADVERSE REACTIONS








INDICATIONS & USAGE

WARNINGS





IBUPROFEN CONTRAINDICATIONS


WARNINGS, Anaphylactoid Reactions,PRECAUTIONS, Preexisting Asthma
WARNINGS

WARNINGS

CARDIOVASCULAR EFFECTS

Cardiovascular Thrombotic Events

WARNINGS)
CONTRAINDICATIONS

Hypertension


Congestive Heart Failure and Edema


Gastrointestinal Effects - Risk of Ulceration, Bleeding, and Perforation


Renal Effects


Advanced Renal Disease


Anaphylactoid Reactions
CONTRAINDICATIONSPRECAUTIONS, Preexisting Asthma)

Skin Reactions


Pregnancy


PRECAUTIONS

General



Hepatic effects


Hematological effects





Preexisting asthma


Ophthalmological effects.


Aseptic Meningitis


Information for Patients

WARNINGS,Cardiovascular Effects
WARNINGS,Gastrointestinal Effects-Risk of UlcerationBleeding and Perforation)



WARNINGS)


Laboratory Tests


Drug Interactions


Diuretics


Lithium


Methotrexate


Warfarin-type anticoagulants


H-2 Antagonists


Pregnancy



Nonteratogenic effects


Labor and Delivery


Nursing Mothers


Pediatric Use


Geriatric Use


IBUPROFEN ADVERSE REACTIONS









OVERDOSAGE





DOSAGE & ADMINISTRATION




Rheumatoid arthritis and osteoarthritis, including flare-ups ofchronic disease:




Mild to moderate pain:


Dysmenorrhea:


HOW SUPPLIED

























INACTIVE INGREDIENT

carnauba wax
silicon dioxide
croscarmellose sodium
hypromellose
magnesium stearate
cellulose, microcrystalline
polydextrose
Polyethylene glycol
polysorbate 80
titanium dioxide

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
















Ibuprofen



Ibuprofen











Ibuprofen

Ibuprofen TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-613(NDC:55111-684)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
IBUPROFEN IBUPROFEN 800 mg

Inactive Ingredients

Ingredient Name Strength
carnauba wax
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYPROMELLOSES
MAGNESIUM STEARATE
cellulose, microcrystalline
POLYDEXTROSE
polyethylene glycol
polysorbate 80
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
white 9 mm 8I OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-613-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075682 2011-05-10


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Be sure to consult your doctor before taking any medication!
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