- 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.
- Stainer DW, Scholte MJ. A simple chemically defined medium for the production of phase I Bordetella pertussis. J Gen Microbiol 1970;63:211-20.
- 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.
- Mueller JH, Miller PA. Variable factors influencing the production of tetanus toxin. J Bacteriol 1954;67(3):271-7.
- 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.
- Wharton M, et al. Diphtheria Toxoid. In: Plotkin SA, Orenstein WA, editors. Vaccines. 4th ed. Philadelphia, PA: W. B. Saunders 2004 p. 211-28.
- Wassilak SGF, et al. Tetanus Toxoid. In: Plotkin SA, Orenstein WA, editors. Vaccines. 4th ed. Philadelphia, PA: W. B. Saunders 2004 p. 745-81.
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.
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.
Sanofi Pasteur Limited
Toronto Ontario Canada
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.
PRINCIPAL DISPLAY PANEL — 0.5 mL Vial Label
6 wks — 6 yrs
Diphtheria and Tetanus
Toxoids and Acellular
Single-dose (0.5 mL) IM onlySanofi Pasteur Limited
Tetanus Toxoids and
10 single-dose vials0.5 mL
For children 6 weeks through 6 years of age.
|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|
|Labeler — Sanofi Pasteur Inc. (086723285)|
|Sanofi Pasteur Limited||208206623||MANUFACTURE|
Revised: 05/2020 Sanofi Pasteur Inc.
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