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

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Isosorbide Dinitrate

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

ISOSORBIDE DINITRATE DESCRIPTION



Isosorbide Dinitrate





CLINICAL PHARMACOLOGY




PHARMACOKINETICS







Clinical Trials




INDICATIONS & USAGE



ISOSORBIDE DINITRATE CONTRAINDICATIONS



WARNINGS




PRECAUTIONS

General






INFORMATION FOR PATIENTS




DRUG INTERACTIONS



CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY



PREGNANCY

Category C


NURSING MOTHERS



PEDIATRIC USE



ISOSORBIDE DINITRATE ADVERSE REACTIONS


OVERDOSAGE


OVERDOSAGE

Hemodynamic Effects








Methemoglobinemia





DOSAGE & ADMINISTRATION

CLINICAL PHARMACOLOGY
CLINICAL PHARMACOLOGY



HOW SUPPLIED


























INACTIVE INGREDIENT

FD&C Red #40 Aluminum Lake
Microcrystalline Cellulose
Lactose Monhydrate
Magnesium Stearate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Isosorbide Dinitrate

Isosorbide Dinitrate

Isosorbide Dinitrate

Isosorbide Dinitrate TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-663(NDC:0781-1635)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
isosorbide dinitrate ISOSORBIDE DINITRATE 5 mg

Inactive Ingredients

Ingredient Name Strength
FD&C RED NO. 40
cellulose, microcrystalline
lactose monohydrate
MAGNESIUM STEARATE

Product Characteristics

Color Size Imprint Code Shape
pink 8 mm GG;259 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-663-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA086221 2011-03-10


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