The following Structured Product Label (SPL) was submitted to the FDA by Bamboo Us Bidco Llc for the product Flucelvax (NDC 83703-084). 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 package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Principal Display Panel – 0.5 mL Carton Label
For use in persons 6 months of age and older
For Intramuscular Use
Ten 0.5 mL, single-dose, pre-filled syringes
Rx Only
Influenza Vaccine
FLUCELVAX
®
2025 - 2026 FORMULA
Seqirus™
L (Flu2t 0007 01)
Principal Display Panel – 0.5 mL Syringe Label
Influenza Vaccine
FLUCELVAX
®
2025 - 2026 Formula
0.5 mL dose
Rx Only
FOR IM USE
For 6 months of age and older
Ty (Flu2t 0007 02)
* Please review the disclaimer below.
