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

  • NDC Code(s): 57826-462-03
  • Packager: Haemonetics Corporation
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated April 27, 2018

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  • 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.

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  • 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.

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  • STERILE,

    nonpryogenic fluid path. Rx only.

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  • RECOMMENDED STORAGE:

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

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  • CAUTION:

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

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  • PRINCIPAL DISPLAY PANEL

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

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