As 3 Listing

Drug Facts

Composition & Product

Active Ingredients

Adenine (0.03 g) Anhydrous Dextrose (1 g)

Inactive Ingredients

Sodium Citrate, Unspecified Form Sodium Chloride Citric Acid Monohydrate Sodium Phosphate, Monobasic, Monohydrate

Identifiers & Packaging

Marketing Status

NDA Active Since 2025-09-15

Medication Information

Storage and Handling

Store at room temperature (25 °C/77 °F). Avoid excessive heat.

Protect from freezing

Description

ADDITIVE SOLUTION FORMULA 3 (AS-3), 300 mL

Each 100 mL contains:

Citric Acid (Monohydrate), USP 0.042 g

Monobasic Sodium Phosphate (Monohydrate), USP 0.276 g

Sodium Chloride, USP 0.410 g

Adenine, USP 0.030 g

Dextrose (Anhydrous), USP 1.000 g

Sodium Citrate (Dihydrate), USP 0.588 g

containing 15 mEq of Sodium.

.

Section 60560-0

I

Intended for use only with automated red cell apheresis devices.

Section 69718-5

ADDITIVE SOLUTION FORMULA 3 (AS-3), 300 ml

Package Label

Manufacturer: GVS TM Inc.

1630 W Industrial Park St

Covina, CA 91722, USA

ADDITIVE SOLUTION FORMULA 3 (AS-3), 300 mL

Intended for use only with automated red cell washing devices

and automated red cell apheresis devices. See appropriate

Operator’s Manual for additional information and complete usage

instructions.

Each 100 mL contains:

Citric Acid (Monohydrate), USP 0.042 g

Monobasic Sodium Phosphate (Monohydrate), USP 0.276 g

Sodium Chloride, USP 0.410 g

Adenine, USP 0.030 g

Dextrose (Anhydrous), USP 1.000 g

Sodium Citrate (Dihydrate), USP 0.588 g

containing 15 mEq of Sodium.

CAUTION: Refer to package insert. Not for direct intravenous

infusion. The pouch is a moisture barrier. Do not use unless

solution is clear and no leaks detected. Single use container.

Discard unused portion. Sterile, nonpyrogenic fluid path.

Sterilized by steam. Rx Only.

Store at room temperature (25 °C/77 °F). Avoid excessive heat.

Protect from freezing.

REF symbol: 0462A-00

LOT symbol

expiry date symbol

template revision number: 126618-00 REV.0

Statement of Idenity

ADDITIVE SOLUTION FORMULA 3 (AS-3), 250 mL

Warnings and Precoutions

Not for direct intravenous infusion

Do not use unless solution is clear and no leaks detected

Single use container. Discard unused portion

Intended for use only with automated red cell washing and apheresis devices

See Operator’s Manual for additional information and complete usage instructions

Store at room temperature. Avoid excessive heat. Protect from freezing

Description of the Product

ADDITIVE SOLUTION FORMULA 3 (AS-3), 250 mL

Each 100 mL contains:

Citric Acid (Monohydrate), USP 0.042 g

Monobasic Sodium Phosphate (Monohydrate), USP 0.042 g

Sodium Chloride, USP 0.410 g

Adenine, USP 0.030 g

Dextrose (Anhydrous), USP 1.000 g

Sodium Citrate (Dihydrate), USP 0.588 g

containing 15 mEq of Sodium.

Intended Use of the Device

Intended for use only with automated red cell washing devices

and automated red cell apheresis devices.

Warnings and Precoutions Section

See appropriate Operator’s Manual for additional information and complete usage instructions.

Not for direct intravenous infusion

Do not use unless solution is clear and no leaks detected

Single use container. Discard unused portion

Intended for use only with automated red cell washing and apheresis devices

Store at room temperature. Avoid excessive heat. Protect from freezing

Structured Label Content

Description (34089-3)

ADDITIVE SOLUTION FORMULA 3 (AS-3), 300 mL

Each 100 mL contains:

Citric Acid (Monohydrate), USP 0.042 g

Monobasic Sodium Phosphate (Monohydrate), USP 0.276 g

Sodium Chloride, USP 0.410 g

Adenine, USP 0.030 g

Dextrose (Anhydrous), USP 1.000 g

Sodium Citrate (Dihydrate), USP 0.588 g

containing 15 mEq of Sodium.

.

Section 60560-0 (60560-0)

I

Intended for use only with automated red cell apheresis devices.

Section 69718-5 (69718-5)

ADDITIVE SOLUTION FORMULA 3 (AS-3), 300 ml

Package Label (Package label)

Manufacturer: GVS TM Inc.

1630 W Industrial Park St

Covina, CA 91722, USA

ADDITIVE SOLUTION FORMULA 3 (AS-3), 300 mL

Intended for use only with automated red cell washing devices

and automated red cell apheresis devices. See appropriate

Operator’s Manual for additional information and complete usage

instructions.

Each 100 mL contains:

Citric Acid (Monohydrate), USP 0.042 g

Monobasic Sodium Phosphate (Monohydrate), USP 0.276 g

Sodium Chloride, USP 0.410 g

Adenine, USP 0.030 g

Dextrose (Anhydrous), USP 1.000 g

Sodium Citrate (Dihydrate), USP 0.588 g

containing 15 mEq of Sodium.

CAUTION: Refer to package insert. Not for direct intravenous

infusion. The pouch is a moisture barrier. Do not use unless

solution is clear and no leaks detected. Single use container.

Discard unused portion. Sterile, nonpyrogenic fluid path.

Sterilized by steam. Rx Only.

Store at room temperature (25 °C/77 °F). Avoid excessive heat.

Protect from freezing.

REF symbol: 0462A-00

LOT symbol

expiry date symbol

template revision number: 126618-00 REV.0

Statement of Idenity (Statement of idenity)

ADDITIVE SOLUTION FORMULA 3 (AS-3), 250 mL

Storage and Handling (Storage and handling)

Store at room temperature (25 °C/77 °F). Avoid excessive heat.

Protect from freezing

Warnings and Precoutions (Warnings and precoutions)

Not for direct intravenous infusion

Do not use unless solution is clear and no leaks detected

Single use container. Discard unused portion

Intended for use only with automated red cell washing and apheresis devices

See Operator’s Manual for additional information and complete usage instructions

Store at room temperature. Avoid excessive heat. Protect from freezing

Description of the Product (Description of the product)

ADDITIVE SOLUTION FORMULA 3 (AS-3), 250 mL

Each 100 mL contains:

Citric Acid (Monohydrate), USP 0.042 g

Monobasic Sodium Phosphate (Monohydrate), USP 0.042 g

Sodium Chloride, USP 0.410 g

Adenine, USP 0.030 g

Dextrose (Anhydrous), USP 1.000 g

Sodium Citrate (Dihydrate), USP 0.588 g

containing 15 mEq of Sodium.

Intended Use of the Device (Intended use of the device)

Intended for use only with automated red cell washing devices

and automated red cell apheresis devices.

Warnings and Precoutions Section (Warnings and precoutions section)

See appropriate Operator’s Manual for additional information and complete usage instructions.

Not for direct intravenous infusion

Do not use unless solution is clear and no leaks detected

Single use container. Discard unused portion

Intended for use only with automated red cell washing and apheresis devices

Store at room temperature. Avoid excessive heat. Protect from freezing

Advanced Ingredient Data

[{"name": "SODIUM CITRATE, UNSPECIFIED FORM", "unii": "1Q73Q2JULR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CHLORIDE", "unii": "451W47IQ8X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE", "unii": "593YOG76RN", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ADENINE", "unii": "JAC85A2161", "classCode": "ACTIB", "strengthNumerator": "0.03", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "ANHYDROUS DEXTROSE", "unii": "5SL0G7R0OK", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "SODIUM CITRATE, UNSPECIFIED FORM", "unii": "1Q73Q2JULR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ADENINE", "unii": "JAC85A2161", "classCode": "ACTIB", "strengthNumerator": "0.03", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE", "unii": "593YOG76RN", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CHLORIDE", "unii": "451W47IQ8X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS DEXTROSE", "unii": "5SL0G7R0OK", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34089-3": "ADDITIVE SOLUTION FORMULA 3 (AS-3), 300 mL Each 100 mL contains: Citric Acid (Monohydrate), USP 0.042 g Monobasic Sodium Phosphate (Monohydrate), USP 0.276 g Sodium Chloride, USP 0.410 g Adenine, USP 0.030 g Dextrose (Anhydrous), USP 1.000 g Sodium Citrate (Dihydrate), USP 0.588 g containing 15 mEq of Sodium. .", "60560-0": "I Intended for use only with automated red cell apheresis devices.", "69718-5": "ADDITIVE SOLUTION FORMULA 3 (AS-3), 300 ml", "Package label": "Manufacturer: GVS TM Inc. 1630 W Industrial Park St Covina, CA 91722, USA ADDITIVE SOLUTION FORMULA 3 (AS-3), 300 mL Intended for use only with automated red cell washing devices and automated red cell apheresis devices. See appropriate Operator’s Manual for additional information and complete usage instructions. Each 100 mL contains: Citric Acid (Monohydrate), USP 0.042 g Monobasic Sodium Phosphate (Monohydrate), USP 0.276 g Sodium Chloride, USP 0.410 g Adenine, USP 0.030 g Dextrose (Anhydrous), USP 1.000 g Sodium Citrate (Dihydrate), USP 0.588 g containing 15 mEq of Sodium. CAUTION: Refer to package insert. Not for direct intravenous infusion. The pouch is a moisture barrier. Do not use unless solution is clear and no leaks detected. Single use container. Discard unused portion. Sterile, nonpyrogenic fluid path. Sterilized by steam. Rx Only. Store at room temperature (25 °C/77 °F). Avoid excessive heat. Protect from freezing. REF symbol: 0462A-00 LOT symbol expiry date symbol template revision number: 126618-00 REV.0", "Statement of idenity": "ADDITIVE SOLUTION FORMULA 3 (AS-3), 250 mL", "Storage and handling": "Store at room temperature (25 °C/77 °F). Avoid excessive heat. Protect from freezing", "Warnings and precoutions": "Not for direct intravenous infusion Do not use unless solution is clear and no leaks detected Single use container. Discard unused portion Intended for use only with automated red cell washing and apheresis devices See Operator’s Manual for additional information and complete usage instructions Store at room temperature. Avoid excessive heat. Protect from freezing", "Description of the product": "ADDITIVE SOLUTION FORMULA 3 (AS-3), 250 mL Each 100 mL contains: Citric Acid (Monohydrate), USP 0.042 g Monobasic Sodium Phosphate (Monohydrate), USP 0.042 g Sodium Chloride, USP 0.410 g Adenine, USP 0.030 g Dextrose (Anhydrous), USP 1.000 g Sodium Citrate (Dihydrate), USP 0.588 g containing 15 mEq of Sodium.", "Intended use of the device": "Intended for use only with automated red cell washing devices and automated red cell apheresis devices.", "Warnings and precoutions section": "See appropriate Operator’s Manual for additional information and complete usage instructions. Not for direct intravenous infusion Do not use unless solution is clear and no leaks detected Single use container. Discard unused portion Intended for use only with automated red cell washing and apheresis devices Store at room temperature. Avoid excessive heat. Protect from freezing"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information