Label: GABAPENTIN capsule

  • NDC Code(s): 16571-867-01, 16571-867-03, 16571-867-10, 16571-867-50, view more
  • Packager: Rising Pharma Holdings, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 3, 2025

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    Gabapentin Capsules are indicated for: Management of postherpetic neuralgia in adults - Adjunctive therapy in the treatment of partial onset seizures, with and without secondary ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Dosage for Postherpetic Neuralgia - In adults with postherpetic neuralgia, gabapentin capsules may be initiated on Day 1 as a single 300 mg dose, on Day 2 as 600 mg/day (300 mg two times a ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Capsules - Gabapentin Capsules, USP 100 mg are size '3' Hard gelatin capsules with white opaque cap and white opaque body, imprinted "100 mg" in blue ink on cap and "236" in blue ...
  • 4 CONTRAINDICATIONS
    Gabapentin capsules are contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients.
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity - Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multiorgan ...
  • 6 ADVERSE REACTIONS
    The following serious adverse reactions are discussed in greater detail in other sections: Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity ...
  • 7 DRUG INTERACTIONS
    7.1 Opioids - Respiratory depression and sedation, sometimes resulting in death, have been reported following coadministration of gabapentin with opioids (e.g., morphine, hydrocodone, oxycodone ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - The totality of available data from published prospective and retrospective cohort studies pertaining to gabapentin use during pregnancy has not indicated an ...
  • 9 DRUG ABUSE AND DEPENDENCE
    9.1 Controlled Substance - Gabapentin capsule contains gabapentin, which is not a controlled substance. 9.2 Abuse - Abuse is the intentional, non-therapeutic use of a drug, even once, for its ...
  • 10 OVERDOSAGE
    Signs of acute toxicity in animals included ataxia, labored breathing, ptosis, sedation, hypoactivity, or excitation. Acute oral overdoses of gabapentin have been reported. Symptoms have ...
  • 11 DESCRIPTION
    The active ingredient in Gabapentin Capsules, USP is gabapentin, which has the chemical name 1-(aminomethyl) cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - The precise mechanisms by which gabapentin produces its analgesic and antiepileptic actions are unknown. Gabapentin is structurally related to the neurotransmitter ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenesis - Gabapentin was administered orally to mice and rats in 2-year carcinogenicity studies. No evidence of drug-related ...
  • 14 CLINICAL STUDIES
    14.1 Postherpetic Neuralgia - Gabapentin was evaluated for the management of postherpetic neuralgia (PHN) in two randomized, double-blind, placebo-controlled, multicenter studies. The ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Gabapentin Capsules, USP are available containing 100 mg, 300 mg or 400 mg of gabapentin, USP, supplied as follows: 100 mg capsules: Size '3' Hard gelatin capsules with white opaque cap and white ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Medication Guide). Administration Information - Inform patients that gabapentin is taken orally with or without food. Drug ...
  • MEDICATION GUIDE
    Gabapentin (GA ba PEN tin) Capsules - What is the most important information I should know about gabapentin capsules? Do not stop taking gabapentin capsules without first talking to your ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    NDC 16571-867-03 - Gabapentin Capsules USP - 100 mg - PHARMACIST: Please dispense the accompanying Medication Guide to each patient. Rx Only - 30 Capsules - NDC 16571-868-03 - Gabapentin Capsules USP - 300 ...
  • INGREDIENTS AND APPEARANCE
    Product Information