DAPTACEL: Package Insert and Label Information (Page 3 of 3)

PRINCIPAL DISPLAY PANEL — 0.5 mL Vial Carton

NDC 49281-286-10

Diphtheria and
Tetanus Toxoids and
Acellular Pertussis
Vaccine Adsorbed

DTaP

10 single-dose vials0.5 mL

Rx only

DAPTACEL®

For children 6 weeks through 6 years of age.

SANOFI PASTEUR

PRINCIPAL DISPLAY PANEL -- 0.5 mL Vial Carton
(click image for full-size original)
DAPTACEL corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated), clostridium tetani toxoid antigen (formaldehyde inactivated), bordetella pertussis toxoid antigen (glutaraldehyde inactivated), bordetella pertussis filamentous hemagglutinin antigen (formaldehyde inactivated), bordetella pertussis pertactin antigen, and bordetella pertussis fimbriae 2/3 antigen injection, suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:49281-286
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) (CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)) CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 15 [Lf] in 0.5 mL
CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) (CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)) CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 5 [Lf] in 0.5 mL
BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED) (BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED)) BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED) 10 ug in 0.5 mL
BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) (BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)) BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) 5 ug in 0.5 mL
BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (BORDETELLA PERTUSSIS PERTACTIN ANTIGEN) BORDETELLA PERTUSSIS PERTACTIN ANTIGEN 3 ug in 0.5 mL
BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN (BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN) BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN 5 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
ALUMINUM PHOSPHATE 1.5 mg in 0.5 mL
FORMALDEHYDE 5 ug in 0.5 mL
GLUTARAL 50 ng in 0.5 mL
PHENOXYETHANOL 3.3 mg in 0.5 mL
WATER
Product Characteristics
Color WHITE (WHITE TO OFF-WHITE) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49281-286-01 1 VIAL in 1 PACKAGE contains a VIAL (49281-286-58)
1 NDC:49281-286-58 0.5 mL in 1 VIAL This package is contained within the PACKAGE (49281-286-01)
2 NDC:49281-286-05 5 VIAL in 1 PACKAGE contains a VIAL (49281-286-58)
2 NDC:49281-286-58 0.5 mL in 1 VIAL This package is contained within the PACKAGE (49281-286-05)
3 NDC:49281-286-10 10 VIAL in 1 PACKAGE contains a VIAL (49281-286-58)
3 NDC:49281-286-58 0.5 mL in 1 VIAL This package is contained within the PACKAGE (49281-286-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103666 05/14/2002
Labeler — Sanofi Pasteur Inc. (086723285)
Establishment
Name Address ID/FEI Operations
Sanofi Pasteur Limited 208206623 MANUFACTURE

Revised: 05/2020 Sanofi Pasteur Inc.

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