FDA Label for Heplisav-b
View Indications, Usage & Precautions
Heplisav-b Product Label
The following document was submitted to the FDA by the labeler of this product Bamboo Us Bidco Llc. 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.
Package Label.Principal Display Panel
Principal Panel - Carton - Vials
Rx only
Hepatitis B Vaccine
(Recombinant),
Adjuvanted
HEPLISAV-B ™
5 x 0.5 mL
single-dose vials
For intramuscular
administration only
DYNAVAX
Principal Panel - Carton - Prefilled Syringes
Rx only
Hepatitis B Vaccine
(Recombinant),
Adjuvanted
HEPLISAV-B ®
5 x 0.5 mL single-dose syringes
For intramuscular
administration only
For Adult Use Only
NEEDLES NOT INCLUDED
DYNAVAX
Principal Panel - Label - Prefilled Syringes
HEPLISAV-B ®
1 dose (0.5 mL)
Hepatitis B Vaccine
(Recombinant), Adjuvanted
For IM use only DO NOT FREEZE
Store at 2-8°C (36-46°F)
Mfd. by Dynavax Tech. Corp.
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