https://www.immunize.org/fda/

Example: 

INDICATIONS AND USAGE ——————————————
Á 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 7th birthday). (1)
————————————— DOSAGE AND ADMINISTRATION —————————————
Á The five dose immunization series consists of a 0.5 mL intramuscular injection administered
at 2, 4, 6 and 15-20 months of age, and at 4-6 years of age. (2.1, 2.2)
———————————— DOSAGE FORMS AND STRENGTHS ————————————
Á Suspension for injection, supplied in single-dose (0.5 mL) vials (3)
——————————————— CONTRAINDICATIONS ———————————————
Á Severe allergic reaction (e.g., anaphylaxis) after a previous dose of any diphtheria toxoid,
tetanus toxoid, or pertussis-containing vaccine, or any component of DAPTACEL. (4.1)
Á Encephalopathy within 7 days of a previous pertussis-containing vaccine with no other
identifiable cause. (4.2)
Á Progressive neurologic disorder until a treatment regimen has been established and the
condition has stabilized. (4.3)
————————————— WARNINGS AND PRECAUTIONS —————————————
Á 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.
(5.2)
- seizures within 3 days after a previous pertussis-containing vaccine. (5.2)
Á If Guillain-Barré syndrome occurred within 6 weeks of receipt of a prior vaccine containing
tetanus toxoid, the risk for Guillain-Barré syndrome may be increased following
DAPTACEL. (5.3)
Á For infants and children with a history of previous seizures, an antipyretic may be administered
(in the dosage recommended in its prescribing information) at the time of vaccination with
DAPTACEL and for the next 24 hours. (5.4)
Á Apnea following intramuscular vaccination has been observed in some infants born prematurely. The decision about when to administer an intramuscular vaccine, including DAPTACEL,to an infant born prematurely should be based on consideration of the individual infant’s medical status and the potential benefits and possible risks of vaccination. (5.7)
Á Syncope (fainting) has been reported following vaccination with DAPTACEL. Procedures
should be in place to prevent falling injury and manage syncopal reactions. (5.8)
——————————————— ADVERSE REACTIONS ———————————————
Á Rates of adverse reactions varied by dose number, with systemic reactions most frequent
following doses 1-3 and injection site reactions most frequent following doses 4 and 5.
Systemic reactions that occurred in >50% of subjects following any dose included fussiness/
irritability, inconsolable crying, and decreased activity/lethargy. Fever ≥38.0°C occurred in
6-16% of US subjects, depending on dose number. Injection site reactions that occurred in
>30% of subjects following any dose included tenderness, redness and increase in arm
circumference. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Sanofi Pasteur Inc., at 1-800-822-2463
(1-800-VACCINE) or VAERS at 1-800-822-7967 and http://vaers.hhs.gov.
——————————————— DRUG INTERACTIONS ———————————————
Á In cases where DAPTACEL and Menactra are to be administered to children 4 through 6 years
of age, the two vaccines should be administered concomitantly or Menactra should be
administered prior to DAPTACEL. Administration of Menactra one month after DAPTACEL has
been shown to reduce meningococcal antibody responses to Menactra. (7.1)
Á Do not mix with any other vaccine in the same syringe or vial. (7.1)
Á Immunosuppressive therapies may reduce the immune response to DAPTACEL. (7.2 )