DAPTACEL (DTaP Vaccine) — 0.5 mL dose, Suspension for injection, package of 10 × 0.5 mL single-dose vials

DAPTACEL (DTaP Vaccine) — 0.5 mL dose, Suspension for injection, package of 10 × 0.5 mL single-dose vials

DAPTACEL (DTaP Vaccine) (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) is a suspension for injection for intramuscular use. DAPTACEL® is a vaccine indicated for active immunization against diphtheria, tetanus and pertussis as a five-dose series in infants and children 6 weeks through 6 years of age (prior to seventh birthday). Supplied as package of 10 × 0.5 mL single-dose vials; NDC 49281-286-10; manufacturer Sanofi Vaccines US Inc. Rx only. DAPTACEL should be stored at 2° to 8°C (35° to 46°F). DO NOT FREEZE. Do not use after expiration date shown on the label.

• Active ingredient or product type: 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; BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN
• Strength/concentration: 0.5 mL dose
• Dosage form and route: Suspension for injection, Intramuscular
• Exact package presentation: package of 10 × 0.5 mL single-dose vials
• NDC/item number: 49281-286-10
• Manufacturer/labeler: Sanofi Vaccines US Inc.
• Storage/handling: DAPTACEL should be stored at 2° to 8°C (35° to 46°F). DO NOT FREEZE. Do not use after expiration date shown on the label.
• Status: Rx only

Important safety information: Carefully consider benefits and risks before administering DAPTACEL to persons with a history of: - fever ≥40.5°C (105°F), hypotonic-hyporesponsive episode (HHE) or persistent, inconsolable crying lasting ≥3 hours within 48 hours after a previous pertussis-containing vaccine.

Refer to the current product labeling for complete indications, preparation or administration instructions, contraindications, warnings, precautions, and storage requirements.