Recombivax Hb Injection, Suspension
FDA Label NDC 83703-086

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 Recombivax Hb (NDC 83703-086). 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 carton, principal display panel - 1.0 ml syringe carton, 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 Carton

10 Single-Dose 0.5-mL Syringes

HEPATITIS B VACCINE
[RECOMBINANT]
RECOMBIVAX HB ®

PEDIATRIC/ADOLESCENT FORMULATION

No Preservative

This package contains 10 single-dose syringes. Each 0.5-mL syringe contains
5 mcg of hepatitis B surface antigen adjuvanted with amorphous aluminum
hydroxyphosphate sulfate.

Vaccine is prepared from fermentation cultures of a recombinant strain of the yeast
Saccharomyces cerevisiaecontaining the gene for the adwsubtype of HBsAg.

This Product Contains No Thimerosal.
Rx only

Principal Display Panel (0.5 mL Syringe Carton)

Principal Display Panel (0.5 mL Syringe Carton)

Principal Display Panel - 1.0 Ml Syringe Carton

10 Single-Dose 1.0-mL Syringes

HEPATITIS B VACCINE
[RECOMBINANT]
RECOMBIVAX HB ®

ADULT FORMULATION

No Preservative

This package contains 10 single-dose syringes. Each 1.0-mL syringe contains
10 mcg of hepatitis B surface antigen adjuvanted with amorphous aluminum
hydroxyphosphate sulfate.

Vaccine is prepared from fermentation cultures of a recombinant strain of the yeast
Saccharomyces cerevisiaecontaining the gene for the adwsubtype of HBsAg.

This Product Contains No Thimerosal.
Rx only

Principal Display Panel (1.0 mL Syringe Carton)

Principal Display Panel (1.0 mL Syringe Carton)

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