AS-3 by GVS TM INC AS-3 solution

AS-3 by

Drug Labeling and Warnings

AS-3 by is a Prescription medication manufactured, distributed, or labeled by GVS TM INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Intended use of the device

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

Storage and handling

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

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

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.
.

STATEMENT OF IDENTITY

ADDITIVE SOLUTION FORMULA 3 (AS-3), 300 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

INTENDED USE OF THE DEVICE

I Intended for use only with automated red cell apheresis devices.

Storage and handling

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

Statement of idenity

ADDITIVE SOLUTION FORMULA 3 (AS-3), 250 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

Package label

Manufacturer: GVS TM Inc.
1630 W Industrial Park St
Covina, CA 91722, USA

ADDITIVE SOLUTION FORMULA 3 (AS-3), 250 mL
Intended for use only with 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: 0460A-00

LOT symbol

expiry date symbol

template revision number 126617-00 REV.0

INGREDIENTS AND APPEARANCE

AS-3 
as-3 solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 87069-462
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ADENINE (UNII: JAC85A2161) (ADENINE - UNII:JAC85A2161)	ADENINE	0.03 g  in 100 mL
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)	DEXTROSE, UNSPECIFIED FORM	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87069-462-33	25 in 1 CARTON
1		300 mL in 1 BAG; Type 0: Not a Combination Product
2	NDC: 87069-462-03	300 mL in 1 BAG; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	BN820915	09/15/2025

AS-3 
as-3 solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 87069-460
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ADENINE (UNII: JAC85A2161) (ADENINE - UNII:JAC85A2161)	ADENINE	0.03 g  in 100 mL
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)	DEXTROSE, UNSPECIFIED FORM	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87069-460-42	24 in 1 CARTON
1		250 mL in 1 BAG; Type 0: Not a Combination Product
2	NDC: 87069-460-02	250 mL in 1 BAG; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	BN820915	09/15/2025

Labeler - GVS TM INC (119067149)

Registrant - GVS TM INC (119067149)

Establishment
Name	Address	ID/FEI	Business Operations
GVS TM INC		119067149	manufacture(87069-462)