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As03 Injection, Solution
FDA Label NDC 58160-855
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Glaxosmithkline Biologicals Sa for the product As03 (NDC 58160-855). 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 other, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Principal Display Panel
NDC 58160-855-19
AS03 Adjuvant Component
NOTICE: NOT TO BE USED ALONE
One vial of AS03 Adjuvant Component and one vial of Antigen Component MUST BE COMBINED BEFORE USE.
10 Vials of AS03 Adjuvant Component
One vial of AS03 Adjuvant Component must be added to one vial of Antigen Component to form ten 0.5-mL doses of vaccine.
Rx only
Rev. 11/20
504407
As03 Adjuvant 10 Count Carton (Image 01)
* Please review the disclaimer below.
