Tiglutik Suspension
FDA Label NDC 11797-210

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Italfarmaco Spa for the product Tiglutik (NDC 11797-210). 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 principal display panel - 300 ml bottle carton, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Principal Display Panel - 300 Ml Bottle Carton

NDC 11797-210-01

Rx only

Tiglutik®
riluzole 
oral suspension
50 mg/10 mL (5 mg/mL)

For Oral Administration
Shake gently before use

Contents of this package:

  • Two bottles, each containing 300 mL
  • Two 10 mL oral syringes
  • Two syringe bottle adapters
  • Two syringe tip caps
  • One Prescribing Information, including
    Instructions for Use

    • This product is a liquid suspension and is
    supplied with syringes for oral administration.
    Before use, please read the enclosed
    Prescribing Information.

    600 mL (two bottles/300 mL each)
    Not To Be Dispensed Separately

    Principal Display Panel (300 mL Bottle Carton)

    Principal Display Panel (300 mL Bottle Carton)

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