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BOOSTRIX- tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed suspension


  1. Provide The Following Information To The Vaccine Recipient, Parent, Or Guardian:
  2. Revised: 4/2019document Id:

Provide The Following Information To The Vaccine Recipient, Parent, Or Guardian: 

Inform of the potential benefits and risks of immunization with BOOSTRIX.
Inform about the potential for adverse reactions that have been temporally associated with administration of BOOSTRIX or other vaccines containing similar components.
Instruct vaccine recipient to report any adverse events to their healthcare provider.
Advise women who receive BOOSTRIX during pregnancy to enroll in the pregnancy registry[see Use in Specific Populations (8.1)].
Give the Vaccine Information Statements, which are required by the National Childhood Vaccine Injury Act of 1986 prior to immunization. These materials are available free of charge at the Centers for Disease Control and Prevention (CDC) website (www.cdc.gov/vaccines).

BOOSTRIX, FLUARIX, INFANRIX, and TIP LOK are trademarks owned by or licensed to the GSK group of companies. The other brands listed are trademarks owned by or licensed to their respective owners and are not owned by or licensed to the GSK group of companies. The makers of these brands are not affiliated with and do not endorse the GSK group of companies or its products.

Manufactured byGlaxoSmithKline Biologicals

Rixensart, Belgium, U.S. License 1617, and

GSK Vaccines GmbH

Marburg, Germany, U.S. License 1617

Distributed byGlaxoSmithKline

Research Triangle Park, NC 27709

2019 GSK group of companies or its licensor.

BTX:31PI

PRINCIPAL DISPLAY PANEL

NDC 58160-842-11

BOOSTRIX

Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed

Tdap

Rxonly

For 10 Years of Age and Older

10 x 0.5-mLSingle-Dose Vials

Made in Belgium

2019 the GSK group of companies or its licensor.

496044 Rev. 2/19
Boostrix 10 count carton
BOOSTRIX
tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed suspension
Product Information
Product TypeVACCINEItem Code (Source)NDC:58160-842
Route of AdministrationINTRAMUSCULAR
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)(UNII: K3W1N8YP13) (CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:K3W1N8YP13)CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)5 [iU] in 0.5 mL
CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)(UNII: IRH51QN26H) (CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:IRH51QN26H)CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)2.5 [iU] in 0.5 mL
BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED)(UNII: QSN5XO8ZSU) (BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED) - UNII:QSN5XO8ZSU)BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED)8 ug in 0.5 mL
BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)(UNII: 8C367IY4EY) (BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:8C367IY4EY)BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)8 ug in 0.5 mL
BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED)(UNII: I05O535NV6) (BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:I05O535NV6)BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED)2.5 ug in 0.5 mL
Inactive Ingredients
Ingredient NameStrength
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
FORMALDEHYDE(UNII: 1HG84L3525)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58160-842-1110 in 1 CARTON
1NDC:58160-842-010.5 mL in 1 VIAL; Type 0: Not a Combination Product
2NDC:58160-842-5210 in 1 CARTON
2NDC:58160-842-430.5 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
3NDC:58160-842-341 in 1 CARTON
3NDC:58160-842-050.5 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA12510607/24/2009
Labeler -GlaxoSmithKline Biologicals SA (372748392)

Revised: 4/2019document Id: 

1374977a-0952-44dc-a1ce-2bdd727ed2eaSet id: cd98bff9-4602-4268-d68d-029a14a5513bVersion: 29Effective Time: 20190425GlaxoSmithKline Biologicals SA



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