Gabapentin

REMEDYREPACK INC.

FULL PRESCRIBING INFORMATION: CONTENTS*

• GABAPENTIN DESCRIPTION
• CLINICAL PHARMACOLOGY
• PHARMACOKINETICS
• CLINICAL STUDIES
• INDICATIONS & USAGE
• GABAPENTIN CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
• LABORATORY TESTS
• DRUG INTERACTIONS
• DRUG & OR LABORATORY TEST INTERACTIONS
• CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
• PREGNANCY
• NURSING MOTHERS
• PEDIATRIC USE
• GERIATRIC USE
• GABAPENTIN ADVERSE REACTIONS
• DRUG ABUSE AND DEPENDENCE
• OVERDOSAGE
• DOSAGE & ADMINISTRATION
• HOW SUPPLIED
• STORAGE AND HANDLING
• PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

FULL PRESCRIBING INFORMATION

GABAPENTIN DESCRIPTION

CLINICAL PHARMACOLOGY

PHARMACOKINETICS

CLINICAL STUDIES

INDICATIONS & USAGE

GABAPENTIN CONTRAINDICATIONS

WARNINGS

PRECAUTIONS

LABORATORY TESTS

DRUG INTERACTIONS

DRUG & OR LABORATORY TEST INTERACTIONS

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

PREGNANCY

NURSING MOTHERS

PEDIATRIC USE

GERIATRIC USE

GABAPENTIN ADVERSE REACTIONS

Body System /Gabapentin CapsulesaPlaceboaAdverse EventN=543N=378%%Body as a WholeCardiovascularDigestive SystemHematologic and Lymphatic SystemsMusculoskeletal SystemNervous SystemRespiratory SystemSkin and AppendagesSpecial SensesLaboratory Deviations







Body System/Gabapentin CapsulesaPlaceboaAdverse EventN=119N=128%%Body as a WholeDigestive SystemNervous SystemRespiratory System

DRUG ABUSE AND DEPENDENCE

OVERDOSAGE

DOSAGE & ADMINISTRATION

CLINICAL PHARMACOLOGY, Pediatrics

HOW SUPPLIED

STORAGE AND HANDLING

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

Gabapentin Gabapentin CAPSULE Product Information Product Type Human prescription drug label Item Code (Source) NDC:49349-220(NDC:53746-101) Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GABAPENTIN GABAPENTIN 100 mg Inactive Ingredients Ingredient Name Strength FERROSOFERRIC OXIDE STARCH, CORN D&C YELLOW NO. 10 FD&C BLUE NO. 2 FD&C RED NO. 40 GELATIN mannitol SHELLAC propylene glycol ferric oxide red SILICON DIOXIDE SODIUM LAURYL SULFATE talc titanium dioxide FERRIC OXIDE YELLOW Product Characteristics Color Size Imprint Code Shape white 16 mm IP101 OVAL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49349-220-02 30 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078428 2011-03-01