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How Supplied


VARIVAX® is a vaccine indicated for active immunization for the prevention of varicella in individuals 12 months of age and older.


Subcutaneous administration only

Recommended Dose And Schedule

VARIVAX is administered as an approximately 0.5-mL dose by subcutaneous injection into the outer aspect of the upper arm (deltoid region) or the anterolateral thigh.

Do not administer this product intravascularly or intramuscularly.

Children (12 months to 12 years of age)

If a second dose is administered, there should be a minimum interval of 3 months between doses [see Clinical Studies].

Adolescents ( ≥ 13 years of age) and Adults

Two doses of vaccine, to be administered with a minimum interval of 4 weeks between doses [see Clinical Studies].

Reconstitution Instructions

When reconstituting the vaccine, use only the sterile diluent supplied with VARIVAX. The sterile diluent does not contain preservatives or other anti-viral substances which might inactivate the vaccine virus.

Use a sterile syringe free of preservatives, antiseptics, and detergents for each reconstitution and injection of VARIVAX because these substances may inactivate the vaccine virus.

To reconstitute the vaccine, first withdraw the total volume of provided sterile diluent into a syringe. Inject all of the withdrawn diluent into the vial of lyophilized vaccine and gently agitate to mix thoroughly. Withdraw the entire contents into the syringe and inject the total volume (approximately 0.5 mL) of reconstituted vaccine subcutaneously. VARIVAX, when reconstituted, is a clear, colorless to pale yellow liquid.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use the product if particulates are present or if it appears discolored.

To minimize loss of potency, administer VARIVAX immediately after reconstitution. Discard if reconstituted vaccine is not used within 30 minutes.

Do not freeze reconstituted vaccine.

Do not combine VARIVAX with any other vaccine through reconstitution or mixing.


Dosage Forms And Strengths

VARIVAX is a suspension for injection supplied as a single-dose vial of lyophilized vaccine to be reconstituted using the accompanying sterile diluent [see DOSAGE AND ADMINISTRATION and HOW SUPPLIED/Storage and Handling]. A single dose after reconstitution is approximately 0.5 mL.

Storage And Handling

No. 4826/4309 —VARIVAX is supplied as follows:

(1) a single-dose vial of lyophilized vaccine (package A), NDC 0006-4826-00
(2) a box of 10 vials of diluent (package B).

No. 4827/4309 —VARIVAX is supplied as follows:

(1) a box of 10 single-dose vials of lyophilized vaccine (package A), NDC 0006-4827-00
(2) a box of 10 vials of diluent (package B).


Vaccine Vial

During shipment, maintain the vaccine at a temperature between -58°F and +5°F (-50°C and -15°C). Use of dry ice may subject VARIVAX to temperatures colder than -58°F (-50°C).

Before reconstitution, store the lyophilized vaccine in a freezer at a temperature between -58°F and +5°F (-50°C and -15°C). Any freezer (e.g., chest, frost-free) that reliably maintains a temperature between -58°F and +5°F (-50°C and -15°C) and has a separate sealed freezer door is acceptable for storing VARIVAX.VARIVAX may be stored at refrigerator temperature (36°F to 46°F, 2°C to 8°C) for up to 72 continuous hours prior to reconstitution. Vaccine stored at 2°C to 8°C which is not used within 72 hours of removal from +5°F (-15°C) storage should be discarded.

Before reconstitution, protect from light.


Diluent Vial

The vial of diluent should be stored separately at room temperature (68°F to 77°F, 20°C to 25°C), or in the refrigerator.

For further product information, call 1-800-9-VARIVAX (1-800-982-7482).

Dist. by: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC., Whitehouse Station, NJ 08889, USA. Revised: July 2014

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 10/21/2015

How Supplied

Report Problems to the Food and Drug Administration


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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