Janssen COVID-19 Vaccine: Package Insert and Label Information (Page 5 of 5)

PRINCIPAL DISPLAY PANEL — 2.5 mL Vial Label

AW_177786

For use
under
Emergency
Use
Authorization

Janssen COVID-19
Vaccine

5 doses of 0.5 mL

Intramuscular Injection

No Preservative

For EXP: www.vaxcheck.jnj

After first use, hold at
2°C to 8°C (36°F to 46°F).
Discard after 6 hours.

Record date and timeof first use:

LOT

PRINCIPAL DISPLAY PANEL — 10 Vial Carton

NDC 59676-580-15
No Preservative

10 Multi-dose Vials
Each vial contains 5 doses of 0.5 mL

Janssen COVID-19 Vaccine
SUSPENSION FOR INTRAMUSCULAR INJECTION

For use under Emergency Use Authorization

Attention: After first use, hold at 2°C to 8°C (36°F to 46°F)
for up to 6 hours or at room temperature (maximally
25°C/77°F) for up to 2 hours. Discard if not used within these times. Do not freeze.

janssen

JANSSEN COVID-19 VACCINE ad26.cov2.s injection, suspension

Product Information Product Type VACCINE Item Code (Source) NDC:59676-580 Route of Administration INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Ad26.COV2.S (Ad26.COV2.S) Ad26.COV2.S 50000000000 {VP} in 0.5 mL

Inactive Ingredients Ingredient Name Strength Citric acid monohydrate Trisodium citrate dihydrate Alcohol Hydroxypropyl betadex Polysorbate 80 Sodium chloride Sodium hydroxide Hydrochloric acid Water

Product Characteristics Color YELLOW (colorless to slightly yellow) Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:59676-580-15 10 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE (59676-580-05) 1 NDC:59676-580-05 2.5 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (59676-580-15)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date EMERGENCY USE AUTHORIZATION 01/04/2021

Labeler — Janssen Products, LP (804684207)

Establishment
Name	Address	ID/FEI	Operations
Janssen		415960780	API MANUFACTURE (59676-580)

Establishment
Name	Address	ID/FEI	Operations
Jannsen Biologics B.V.		409612918	API MANUFACTURE (59676-580)

Establishment
Name	Address	ID/FEI	Operations
Grand River Aseptic Manufacturing, Inc.		005593490	MANUFACTURE (59676-580)

Establishment
Name	Address	ID/FEI	Operations
Emergent Manufacturing Operations Baltimore LLC		968316831	MANUFACTURE (59676-580), ANALYSIS (59676-580)

Establishment
Name	Address	ID/FEI	Operations
Packaging Coordinators, LLC		078525133	PACK (59676-580), LABEL (59676-580)

Establishment
Name	Address	ID/FEI	Operations
Catalent Indiana, LLC		172209277	MANUFACTURE (59676-580), PACK (59676-580), ANALYSIS (59676-580)

Revised: 05/2022 Janssen Products, LP