HAEMONETICS ADDITIVE SOLUTION FORMULA 3 (AS-3)- citric acid monohydrate, sodium phosphate, monobasic, monohydrate, sodium chloride, adenine, anhydrous dextrose, trisodium citrate dihydrate solution

Haemonetics Additive Solution Formula 3 (AS-3) by

Drug Labeling and Warnings

Haemonetics Additive Solution Formula 3 (AS-3) by is a Prescription medication manufactured, distributed, or labeled by Haemonetics Corporation, Haemonetics Manufacturing Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Additive Solution Formula 3 (AS-3) 300 mL

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:

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,

nonpryogenic fluid path. Rx only.

RECOMMENDED STORAGE:

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

CAUTION:

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

PRINCIPAL DISPLAY PANEL

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

Product Label - Package

INGREDIENTS AND APPEARANCE

HAEMONETICS ADDITIVE SOLUTION FORMULA 3 (AS-3) 
citric acid monohydrate, sodium phosphate, monobasic, monohydrate, sodium chloride, adenine, anhydrous dextrose, trisodium citrate dihydrate solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 57826-462
Route of Administration	EXTRACORPOREAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)	ANHYDROUS CITRIC ACID	4.2 mg  in 1 mL
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN) (PHOSPHATE ION - UNII:NK08V8K8HR)	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	27.6 mg  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698, SODIUM CATION - UNII:LYR4M0NH37)	SODIUM CHLORIDE	41 mg  in 1 mL
ADENINE (UNII: JAC85A2161) (ADENINE - UNII:JAC85A2161)	ADENINE	3 mg  in 1 mL
ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)	ANHYDROUS DEXTROSE	100 mg  in 1 mL
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)	ANHYDROUS CITRIC ACID	58.8 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57826-462-03	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	BN000127	01/07/2013

Labeler - Haemonetics Corporation (057827420)

Establishment
Name	Address	ID/FEI	Business Operations
Haemonetics Corporation		942344649	manufacture(57826-462)