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





WARNINGS
WARNINGS

WARNINGS

IBUPROFEN DESCRIPTION




Ibuprofen



CLINICAL PHARMACOLOGY


ADVERSE REACTIONS


ADVERSE REACTIONS








INDICATIONS & USAGE

WARNINGS





IBUPROFEN CONTRAINDICATIONS



WARNINGS, Anaphylactoid ReactionsPRECAUTIONS, Preexisting Asthma
WARNINGS

WARNINGS






GI WARNINGS
CONTRAINDICATIONS












CONTRAINDICATIONSPRECAUTIONS, Preexisting Asthma





PRECAUTIONS




















INFORMATION FOR PATIENTS


WARNINGS, Cardiovascular Effects
WARNINGS, Gastrointestinal Effects-Risk of Ulceration, Bleeding and Perforation



WARNINGS


LABORATORY TESTS




DRUG INTERACTIONS






WARNINGS, Renal Effects










PREGNANCY







LABOR & DELIVERY



NURSING MOTHERS



PEDIATRIC USE



GERIATRIC USE



IBUPROFEN ADVERSE REACTIONS





Incidence Greater Than 1%Precise Incidence UnknownPrecise Incidence(but less than 3%)(but less than 1%)UnknownProbable Causal RelationshipProbable Causal Relationship**(but less than 1%)Causal RelationshipUnknown**GASTROINTESTINALCENTRAL NERVOUS SYSTEMPRECAUTIONSDERMATOLOGICSPECIAL SENSESPRECAUTIONSHEMATOLOGICPRECAUTIONSMETABOLIC/ENDOCRINECARDIOVASCULARALLERGICCONTRAINDICATIONSRENALPRECAUTIONSMISCELLANEOUS




OVERDOSAGE






DOSAGE & ADMINISTRATION

WARNINGS






CLINICAL PHARMACOLOGY





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:49349-203(NDC:55111-683)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
IBUPROFEN IBUPROFEN 600 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 17 mm 6I OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-203-02 30 in 1 BLISTER PACK
2 NDC:49349-203-03 20 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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