UNASYN® How Supplied/Storage and Handling

(ampicillin sodium, sulbactam sodium PHARMACY BULK PACKAGE)

HOW SUPPLIED

UNASYN (ampicillin sodium/sulbactam sodium), a sterile off-white dry powder, is available in Pharmacy Bulk Package containing ampicillin sodium and sulbactam sodium equivalent to 10 g ampicillin and 5 g sulbactam × 1 (NDC 0049-0024-28).

UNASYN sterile powder is to be stored at or below 30°C (86°F) prior to reconstitution.

OTHER SIZE PACKAGES AVAILABLE

UNASYN is also supplied in glass vial and piggyback bottles in the following package sizes:

Vials containing 1.5 g (NDC 0049-0013-83) equivalent of UNASYN (1 g ampicillin as the sodium salt plus 0.5 g sulbactam as the sodium salt)

Vials containing 3 g (NDC 0049-0014-83) equivalent of UNASYN (2 g ampicillin as the sodium salt plus 1 g sulbactam as the sodium salt)

ADD-Vantage® package of 5 vials (NDC 0049-0031-02). Each vial containing 1.5 g (NDC 0049-0031-01) equivalent of UNASYN (1 g ampicillin as the sodium salt plus 0.5 g sulbactam as the sodium salt) are distributed by Pfizer Inc.

ADD-Vantage package of 5 vials (NDC 0049-0032-02). Each vial containing 3 g (NDC 0049-0032-01) equivalent of UNASYN (2 g ampicillin as the sodium salt plus 1 g sulbactam as the sodium salt) are distributed by Pfizer Inc.

The 1.5 g UNASYN ADD-Vantage vials are only to be used with the ADD-Vantage Flexible Diluent Container containing 0.9% Sodium Chloride Injection, USP, 50 mL, 100 mL, or 250 mL sizes.

The 3 g UNASYN ADD-Vantage vials are only to be used with the ADD-Vantage Flexible Diluent Container containing 0.9% Sodium Chloride Injection, USP, 100 mL or 250 mL sizes.

ADD-Vantage is a registered trademark of Hospira Inc., a Pfizer company.

To report SUSPECTED ADVERSE EVENTS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.

This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.

Rx only

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LAB-0018-20.0
Revised October 2020

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How Supplied/Storage and Handling

HOW SUPPLIED

UNASYN (ampicillin sodium/sulbactam sodium), a sterile off-white dry powder, is available in Pharmacy Bulk Package containing ampicillin sodium and sulbactam sodium equivalent to 10 g ampicillin and 5 g sulbactam × 1 (NDC 0049-0024-28).

UNASYN sterile powder is to be stored at or below 30°C (86°F) prior to reconstitution.

OTHER SIZE PACKAGES AVAILABLE

UNASYN is also supplied in glass vial and piggyback bottles in the following package sizes:

Vials containing 1.5 g (NDC 0049-0013-83) equivalent of UNASYN (1 g ampicillin as the sodium salt plus 0.5 g sulbactam as the sodium salt)

Vials containing 3 g (NDC 0049-0014-83) equivalent of UNASYN (2 g ampicillin as the sodium salt plus 1 g sulbactam as the sodium salt)

ADD-Vantage® package of 5 vials (NDC 0049-0031-02). Each vial containing 1.5 g (NDC 0049-0031-01) equivalent of UNASYN (1 g ampicillin as the sodium salt plus 0.5 g sulbactam as the sodium salt) are distributed by Pfizer Inc.

ADD-Vantage package of 5 vials (NDC 0049-0032-02). Each vial containing 3 g (NDC 0049-0032-01) equivalent of UNASYN (2 g ampicillin as the sodium salt plus 1 g sulbactam as the sodium salt) are distributed by Pfizer Inc.

The 1.5 g UNASYN ADD-Vantage vials are only to be used with the ADD-Vantage Flexible Diluent Container containing 0.9% Sodium Chloride Injection, USP, 50 mL, 100 mL, or 250 mL sizes.

The 3 g UNASYN ADD-Vantage vials are only to be used with the ADD-Vantage Flexible Diluent Container containing 0.9% Sodium Chloride Injection, USP, 100 mL or 250 mL sizes.

ADD-Vantage is a registered trademark of Hospira Inc., a Pfizer company.

To report SUSPECTED ADVERSE EVENTS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.

This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.

Rx only

Logo

LAB-0018-20.0
Revised October 2020

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Report Adverse Event

Pfizer Safety

To report an adverse event related to the Pfizer-BioNTech COVID-19 Vaccine, and you are not part of a clinical trial* for this product, click the link below to submit your information:

Pfizer Safety Reporting Site

*If you are involved in a clinical trial for this product, adverse events should be reported to your coordinating study site.

If you cannot use the above website, or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at (800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatch or call (800) 822-7967.