Principal Display Panel - 0.5 Ml Syringe Label
Influenza Vaccine
Fluzone
®
Rx only
2025-2026 Formula
No Preservative
For IM Use
0.5 mL Single-Dose
Mfd by: Sanofi Pasteur Inc.
Principal Display Panel (0.5 mL Syringe Label)
Fluzone Trivalent Northern Hemisphere Injection, Suspension
FDA Label NDC 83703-083
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bamboo Us Bidco Llc for the product Fluzone Trivalent Northern Hemisphere (NDC 83703-083). 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 - 0.5 ml syringe label, principal display panel - 0.5 ml syringe package, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Principal Display Panel - 0.5 Ml Syringe Package
2025-2026
Formula
Influenza Vaccine
Fluzone
®
Rx only
For Intramuscular Use
For 6 months of age and older
10 single-dose prefilled syringes 0.5 mL each
sanofi
Principal Display Panel (0.5 mL Syringe Package)
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