Diltiazem Hydrochloride

REMEDYREPACK INC.

FULL PRESCRIBING INFORMATION: CONTENTS*

• DILTIAZEM HYDROCHLORIDE DESCRIPTION
• CLINICAL PHARMACOLOGY
• PHARMACODYNAMICS
• PHARMACOKINETICS AND METABOLISM
• INDICATIONS & USAGE
• DILTIAZEM HYDROCHLORIDE CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
• DRUG INTERACTIONS
• CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
• PREGNANCY
• NURSING MOTHERS
• PEDIATRIC USE
• GERIATRIC USE
• DILTIAZEM HYDROCHLORIDE ADVERSE REACTIONS
• OVERDOSAGE
• DOSAGE & ADMINISTRATION
• HOW SUPPLIED
• PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

FULL PRESCRIBING INFORMATION

DILTIAZEM HYDROCHLORIDE DESCRIPTION

CLINICAL PHARMACOLOGY

PHARMACODYNAMICS

PHARMACOKINETICS AND METABOLISM

INDICATIONS & USAGE

DILTIAZEM HYDROCHLORIDE CONTRAINDICATIONS

WARNINGS

PRECAUTIONS

DRUG INTERACTIONS

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

PREGNANCY

NURSING MOTHERS

PEDIATRIC USE

GERIATRIC USE

DILTIAZEM HYDROCHLORIDE ADVERSE REACTIONS

Adverse Events (COSTART Term)n=50 # pts (%)Up to 360 mg n=158 # pts (%)540 mg n=49 # pts (%)*


hepatic warnings

OVERDOSAGE

DOSAGE & ADMINISTRATION

Concomitant use with Other Cardiovascular Agents.


WARNINGSPRECAUTIONS



Sprinkling the Capsule Contents on Food

HOW SUPPLIED

StrengthDescriptionQuantityNDC#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE Product Information Product Type Human prescription drug label Item Code (Source) NDC:49349-484(NDC:0258-3688) Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DILTIAZEM HYDROCHLORIDE DILTIAZEM 180 mg Inactive Ingredients Ingredient Name Strength cellulose, microcrystalline SUCROSE povidone talc MAGNESIUM STEARATE HYPROMELLOSES titanium dioxide GELATIN FD&C BLUE NO. 1 FD&C RED NO. 40 D&C RED NO. 28 FD&C GREEN NO. 3 FERROSOFERRIC OXIDE Product Characteristics Color Size Imprint Code Shape blue 18 mm 180 CAPSULE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49349-484-02 30 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020939 2011-08-17