Vaccine Information: Moderna COVID-19 Vaccine
MODERNA COVID-19 VACCINE- cx-024414 injection, suspension
Moderna US, Inc.
CLINICAL PHARMACOLOGY
INDICATIONS AND USAGE
CONTRAINDICATIONS
WARNINGS
PRECAUTIONS
General
Information for Patients
Laboratory Tests
Interactions
Drug Interactions
Drug/Laboratory Test Interactions
Carcinogenesis, Mutagenesis, Impairment of Fertility
Pregnancy
Labor and Delivery
Nursing Mothers
Pediatric Use
Geriatric Use
ADVERSE REACTIONS
DRUG ABUSE AND DEPENDENCE
Controlled Substance
Abuse
Dependence
OVERDOSAGE
DOSAGE AND ADMINISTRATION
HOW SUPPLIED
Package/Label Display Panel
NDC 80777-279-05
Moderna COVID-19 Vaccine
Suspension for Intramuscular Injection
For use under Emergency Use Authorization
Age 6mo through 5y
Vial contains 10 doses of 0.25 mL
Package/Label Display Panel
NDC 80777-279-99
Moderna COVID-19 Vaccine
Suspension for Intramuscular Injection
For use under Emergency Use Authorization
For age 6 months through 5 years
STORE FROZEN between -50° to -15°C (-58° to 5°F).
Protect from light
Ten multi-dose vials
Each vial contains 10 doses of 0.25 mL
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Labeler — Moderna US, Inc. (117626450) |
Establishment | |||
Name | Address | ID/FEI | Operations |
ModernaTX, Inc. | 116912313 | ANALYSIS (80777-279), API MANUFACTURE (80777-279) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Catalent Indiana, LLC | 172209277 | MANUFACTURE (80777-279), ANALYSIS (80777-279), LABEL (80777-279), PACK (80777-279) |
Revised: 04/2022 Moderna US, Inc.
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