Gabapentin

REMEDYREPACK INC.

FULL PRESCRIBING INFORMATION: CONTENTS*

• GABAPENTIN DESCRIPTION
• CLINICAL PHARMACOLOGY
• PHARMACOKINETICS
• 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

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 Preferred TermGabapentin CapsulesPlaceboPreferred TermN = 336N = 227%%Body as a WholeDigestive SystemMetabolic and Nutritional DisordersNervous SystemRespiratory SystemSkin and AppendagesSpecial Senses




WARNINGS, Neuropsychiatric Adverse Events





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







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

DRUG ABUSE AND DEPENDENCE

DRUG ABUSE AND DEPENDENCE

OVERDOSAGE

OVERDOSAGE

DOSAGE & ADMINISTRATION

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:49349-265(NDC:53746-103) Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GABAPENTIN GABAPENTIN 400 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 brown 21 mm IP103 OVAL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49349-265-02 30 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078428 2011-03-31