Vaccine Information: DAPTACEL (Page 3 of 3)

15 REFERENCES

1
Stratton KR, et al. editors. Adverse events associated with childhood vaccines; evidence bearing on causality. Washington D.C.: National Academy Press. 1994. p. 67-117.
2
Stainer DW, Scholte MJ. A simple chemically defined medium for the production of phase I Bordetella pertussis. J Gen Microbiol 1970;63:211-20.
3
Stainer DW. Production of diphtheria toxin. In: Manclark CR, editor. Proceedings of an informal consultation on the World Health Organization requirements for diphtheria, tetanus, pertussis and combined vaccines. United States Public Health Service, Bethesda, MD. DHHS 91-1174. 1991. p. 7-11.
4
Mueller JH, Miller PA. Variable factors influencing the production of tetanus toxin. J Bacteriol 1954;67(3):271-7.
5
Department of Health and Human Services, Food and Drug Administration. Biological products; bacterial vaccines and toxoids; implementation of efficacy review; proposed rule. Federal Register 1985;50(240):51002-117.
6
Wharton M, et al. Diphtheria Toxoid. In: Plotkin SA, Orenstein WA, editors. Vaccines. 4th ed. Philadelphia, PA: W. B. Saunders 2004 p. 211-28.
7
Wassilak SGF, et al. Tetanus Toxoid. In: Plotkin SA, Orenstein WA, editors. Vaccines. 4th ed. Philadelphia, PA: W. B. Saunders 2004 p. 745-81.

16 HOW SUPPLIED/STORAGE AND HANDLING

The vial stopper for this product is not made with natural rubber latex.

DAPTACEL is supplied in a single-dose vial (NDC No. 49281-286-58):

in packages of 1 vial: NDC No. 49281-286-01;

in packages of 5 vials: NDC No. 49281-286-05;

in packages of 10 vials: NDC No. 49281-286-10.

DAPTACEL should be stored at 2° to 8°C (35° to 46°F). DO NOT FREEZE. Product which has been exposed to freezing should not be used. Do not use after expiration date shown on the label.

17 PATIENT COUNSELING INFORMATION

Inform the parent or guardian of the following:

  • The potential benefits and risks of immunization with DAPTACEL.
  • The common adverse reactions that have occurred following administration of DAPTACEL or other vaccines containing similar components.
  • Other adverse reactions can occur. Call healthcare provider with any adverse reactions of concern.

Provide the Vaccine Information Statements (VIS), which are required by the National Childhood Vaccine Injury Act of 1986.

Manufactured by:
Sanofi Pasteur Limited
Toronto Ontario Canada

Distributed by:
Sanofi Pasteur Inc.
Swiftwater PA 18370 USA

US Patents: 4500639, 4687738, 4784589, 4997915, 5444159, 5667787, 5877298.

DAPTACEL® is a registered trademark of Sanofi Pasteur Limited.

R11-0220 USA

PRINCIPAL DISPLAY PANEL — 0.5 mL Vial Label

6 wks — 6 yrs
DTaP

NDC 49281-286-58

Diphtheria and Tetanus
Toxoids and Acellular
Pertussis Vaccine
Adsorbed

DAPTACEL®

Rx only

Single-dose (0.5 mL) IM onlySanofi Pasteur Limited

PRINCIPAL DISPLAY PANEL -- 0.5 mL Vial Label
(click image for full-size original)

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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