Vaccine Information: Vivotif (Page 3 of 3)

Vivotif® is a registered trademark of Emergent Travel Health Inc.

US-License No. 2199

Manufactured by:
Emergent Travel Health Inc., 555 Twin Dolphin Dr., Ste. 360
Redwood City, CA 94065

Distributed by:
Emergent Travel Health Inc., 555 Twin Dolphin Dr., Ste. 360Redwood City, CA 94065

© 2020 Emergent Travel Health Inc. All rights reserved.

Rx Only

Version: September 2020

1003798

PRINCIPAL DISPLAY PANEL — Carton Label

Principal Display Panel -- Carton Label
(click image for full-size original)

Carton Label

REFRIGERATE

NDC 69401-000-02

Typhoid Vaccine Live Oral Ty21a
Vivotif®

Each capsule (dose) contains 2.0-10.0×109 CFU
live attenuated Salmonella typhi strain Ty21a

emergent
biosolutions®

Distributed by:
Emergent Travel Health Inc.
555 Twin Dolphin Dr., Ste. 360
Redwood City
CA 94065

GTIN
S/N
EXP
LOT

Typhoid Vaccine Live Oral Ty21a
Vivotif®

Salmonella typhi strain Ty21a — Contains no preservative PaxVax

Typhoid Vaccine Live Oral Ty21a
Vivotif®

4 enteric-coated capsules p.o.
Live vaccine for oral, active immunization against typhoid fever
Store at 2-8 °C (36-46 °F)
in a dry place and protected from light
Administration and dosage: see package insert

US-Licence No. 2199Emergent Travel Health Inc., Redwood City, CA 94065, USA

Rx ONLY

PRINCIPAL DISPLAY PANEL — Blister Label

Principal Display Panel -- Blister Label
(click image for full-size original)

Blister Label

Typhoid Vaccine
Live Oral Ty21a
Vivotif®

Each capsule: 2.0-10.0×109 CFU/capsule
Dosage: see package insert

Emergent Travel Health Inc., USA

US-Licence No. 2199NDC 69401-000-01

Rx only

VIVOTIF salmonella typhi ty21a capsule, coated
Product Information
Product Type VACCINE Item Code (Source) NDC:69401-000
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALMONELLA TYPHI TY21A LIVE ANTIGEN (SALMONELLA TYPHI TY21A LIVE ANTIGEN) SALMONELLA TYPHI TY21A LIVE ANTIGEN 6000000000 [CFU]
Inactive Ingredients
Ingredient Name Strength
ASCORBIC ACID
LACTOSE, UNSPECIFIED FORM
SUCROSE
AMINO ACIDS
MAGNESIUM STEARATE
Product Characteristics
Color PINK (salmon/white) Score no score
Shape OVAL Size 16mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69401-000-02 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK (69401-000-01)
1 NDC:69401-000-01 4 CAPSULE, COATED in 1 BLISTER PACK This package is contained within the CARTON (69401-000-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103123 03/16/1992
Labeler — Emergent Travel Health Inc. (806518598)

Revised: 04/2021 Emergent Travel Health Inc.

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