FDA Label for As03

View Indications, Usage & Precautions

As03 Product Label

The following document was submitted to the FDA by the labeler of this product Glaxosmithkline Biologicals Sa. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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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


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