Gabapentin
FDA Label NDC 61919-417
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Direct Rx for the product Gabapentin (NDC 61919-417). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding 1 indications and usage, 2 dosage and administration, 3 dosage forms and strengths, 5 warnings and precautions, 6 adverse reactions, 6 adverse reactions part two, 7 drug interactions, 8 use in specific populations, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
2 Dosage And Administration
3 Dosage Forms And Strengths
5 Warnings And Precautions
6 Adverse Reactions
6 Adverse Reactions Part Two
7 Drug Interactions
8 Use In Specific Populations
9 Drug Abuse And Dependence
10 Overdosage
11 Description
12 Clinical Pharmacology
13 Nonclinical Toxicology
14 Clinical Studies
16 How Supplied/Storage And Handlling
17 Patient Counseling Information
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