FDA.reportPublic FDA data

Haemonetics Additive Solution Formula 3 (AS-3)

Manufacturer
Haemonetics Corporation | Haemonetics Manufacturing Inc.
Effective date
2020-09-30
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
9
Source
legacy-cache
Hydrated at
2026-08-01 23:00:37

Label at a glance#

ProductHaemonetics Additive Solution Formula 3 (AS-3)
Active ingredientCITRIC ACID MONOHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, SODIUM CHLORIDE, ADENINE, ANHYDROUS DEXTROSE, TRISODIUM CITRATE DIHYDRATE
Label structure7 sections

Storage and handling

Room temperature (25 degree C/77 degree F). Avoid excessive heat. Protect from freezing.

Label contents#

Full prescribing information#

Additive Solution Formula 3 (AS-3) 300 mL

SPL UNCLASSIFIED SECTION

Intended for use only with automated red cell apheresis devices. See 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:

WARNINGS SECTION


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,

SPL UNCLASSIFIED SECTION

nonpryogenic fluid path. Rx only.

CAUTION:

INFORMATION FOR PATIENTS SECTION

L322, Rev. E - 01  Product code 462A  Haemonatics Corporation  Braintree, MA 02184 USA   Lot No.    Exp. Date.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HAEMONETICS Additive Solution Formula 3 (AS-3) 250 mL  Haemonatics Corporation  Braintree, MA 02184 USA

Product Label - Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ADENINEACTIVE INGREDIENTJAC85A21613
ANHYDROUS DEXTROSEACTIVE INGREDIENT5SL0G7R0OK3
CITRIC ACID MONOHYDRATEACTIVE INGREDIENT2968PHW8QP3
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8X3
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEACTIVE INGREDIENT593YOG76RN3
TRISODIUM CITRATE DIHYDRATEACTIVE INGREDIENTB22547B95K3
ADENINEACTIVE MOIETYJAC85A21613
ANHYDROUS CITRIC ACIDACTIVE MOIETYXF417D3PSL3
ANHYDROUS DEXTROSEACTIVE MOIETY5SL0G7R0OK3
PHOSPHATE IONACTIVE MOIETYNK08V8K8HR3
SODIUM CATIONACTIVE MOIETYLYR4M0NH373
WATERINACTIVE INGREDIENT059QF0KO0R3

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57826-46257826-462-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRIC ACID MONOHYDRATE2968PHW8QPACTIM
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNACTIB
SODIUM CHLORIDE451W47IQ8XACTIB
ADENINEJAC85A2161ACTIB
ANHYDROUS DEXTROSE5SL0G7R0OKACTIB
TRISODIUM CITRATE DIHYDRATEB22547B95KACTIM
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
018dd6d5-a3f9-b024-e063-6394a90a6ed2e6775fa2-9f23-4d71-be07-1e9e4d6265d02023-07-28WarningsExact identifier
spl set id: e6775fa2-9f23-4d71-be07-1e9e4d6265d0

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.