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

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
WARNINGS

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)


DRUG INTERACTIONS



Diuretics


Lithium


Methotrexate


Warfarin-type anticoagulants


H-2 Antagonists


PREGNANCY




Nonteratogenic effects


LABOR & 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

























PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Ibuprofen



Ibuprofen
















Ibuprofen




Ibuprofen

Ibuprofen

Ibuprofen TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-205(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 BULLET

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-205-02 30 in 1 BLISTER PACK
2 NDC:49349-205-04 14 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075682 2011-04-21


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Be sure to consult your doctor before taking any medication!
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