FDA Label for Vaqta
View Indications, Usage & Precautions
Vaqta 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.
Principal Display Panel - 0.5 Ml Vials Carton
10 Single-dose ~25U/0.5-mL Vials
(HEPATITIS A VACCINE, INACTIVATED)
VAQTA
®
PEDIATRIC/ADOLESCENT
0.5 mL vial contains approximately 25U of hepatitis A virus antigen on an Amorphous aluminum
hydroxyphosphate sulfate adjuvant. Hepatitis A virus is grown in cell culture in human MRC-5
diploid fibroblasts.
Rx only
Principal Display Panel - 0.5 Ml Syringes Carton
10 Single-Dose 0.5-mL Syringes
[HEPATITIS A VACCINE,
INACTIVATED]
VAQTA
®
PEDIATRIC/ADOLESCENT
FORMULATION
This package contains 10 single-dose syringes.
Each 0.5-mL syringe contains approximately 25U of hepatitis A virus antigen
on an amorphous aluminum hydroxyphosphate sulfate adjuvant.
Hepatitis A virus is grown in cell culture in human MRC-5 diploid fibroblasts.
Rx only
Principal Display Panel - 1 Ml Vials Carton
10 Single-dose
~50U/1-mL Vials
(HEPATITIS A VACCINE, INACTIVATED)
VAQTA
®
ADULT FORMULATION
1 mL vial contains approximately 50U of hepatitis A virus antigen on an Amorphous aluminum
hydroxyphosphate sulfate adjuvant. Hepatitis A virus is grown in cell culture in human MRC-5
diploid fibroblasts.
Rx only
Principal Display Panel - 1 Ml Syringes Carton
10 Single-Dose 1-mL Syringes
[HEPATITIS A VACCINE,
INACTIVATED]
VAQTA
®
ADULT FORMULATION
This package contains 10 single-dose syringes.
Each 1-mL syringe contains approximately 50U of hepatitis A virus antigen
on an amorphous aluminum hydroxyphosphate sulfate adjuvant.
Hepatitis A virus is grown in cell culture in human MRC-5 diploid fibroblasts.
Rx only
Principal Display Panel - 1 Ml Vial Carton
1 Single-dose
~50U/1-mL Vial
(HEPATITIS A
VACCINE,
INACTIVATED)
VAQTA
®
ADULT
FORMULATION
1 mL contains approximately 50U
of hepatitis A virus antigen on an
Amorphous aluminum hydroxyphos-
phate sulfate adjuvant.
Hepatitis A virus is grown in cell
culture in human MRC-5 diploid
fibroblasts.
Rx only
* Please review the disclaimer below.
