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Bal-Care DHA Essential (PruGen, Inc.)

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KIT 6 BLISTER PACK in 1 CARTON (42546-185-30) > 1 KIT in 1 BLISTER PACK Label Information

Complete Bal-Care DHA Essential Information

  • DESCRIPTION

    SUPPLEMENT FACTS
    Serving Size 1 Tablet:
    VITAMINS
    A (beta carotene)  . . . . . . . . . . . . . . . . . . . . . . . . . . 2,850 IU    36% Daily Value
    C (ascorbic acid)    . . . . . . . . . . . . . . . . . . . . . . . . . . 120 mg    200% Daily Value
    D (cholecalciferol)    . . . . . . . . . . . . . . . . . . . . . . . . .840 IU    210% Daily Value
    E (dl-alpha tocopheryl acetate)  . . . . . . . . . . . . . .3 mg    10% Daily Value
    B1 (thiamine mononitrate)  . . . . . . . . . . . . . . . . . . .1.8 mg    106% Daily Value
    B2 (riboflavin)   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4 mg    200% Daily Value
    Niacinamide   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 mg    100% Daily Value
    B6 (pyridoxine hydrochloride)  . . . . . . . . . . . . . . .50 mg    2000% Daily Value
    Folic acid    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1 mg    125% Daily Value
    B12 (cyanocobalamin)   . . . . . . . . . . . . . . . . . . . . . . 12 mcg    150% Daily Value
     
    MINERALS
    Calcium (calcium carbonate)  . . . . . . . . . . . . . . . . 219 mg    17% Daily Value
    Iron (as sodium iron EDTA and polysaccharide iron complex) . . .27 mg    150% Daily Value
    Magnesium (magnesium oxide)  . . . . . . . . . . . . . 25 mg    6% Daily Value
    Zinc (zinc oxide)  . . . . . . . . . . . . . . . . . . . . . . . . .  . . . 25 mg    167% Daily Value
    Copper (cupric oxide)  . . . . . . . . . . . . . . . . . . . . . . . .2 mg    100% Daily Value

    Service Size 1 Softgel:
    374 mg purified omega-3 fatty acids including:
    At least 262 mg DHA (docosahexaenoic acid); also contains at least 112 mg of other omega-3 fatty acids.

    OTHER TABLET INGREDIENTS:
    Microcrystalline Cellulose, Hydroxypropyl Methylcellulose, Crospovidone, Maltodextrin, Acacia Gum, Silicon Dioxide, Triacetin, Magnesium Stearate, Titanium Dioxide, Polydextrose, Yellow #6 Lake, Blue #2 Lake, Red #40 Lake.

    OTHER SOFTGEL INGREDIENTS:
    Ammonium Hydroxide, Ethylcellulose, Gelatin, Glycerin, Medium Chain Triglycerides, Oleic Acid, Sodium Alginate, Stearic Acid, Vanillin.
    Softgel contains fish and soybeans





  • INSTRUCTIONS FOR USE

    Directions:  
    Before, during and after pregnancy, one tablet and one enteric-coated softgel capsule taken by mouth daily, or as directed by a physician.

    Use:  To provide vitamin and mineral supplementation throughout pregnancy and during the postnatal period for both the lactating and non lactating mother. It is also useful for improving nutritional status prior to conception.


     


  • WARNINGS AND PRECAUTIONS

    WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

    Warnings:  Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient.

    Precautions:  Folic acid especially in doses above 1.0 mg daily may obscure pernicious anemia (hematologic remission may occur while neurological manifestations remain progressive). Caution should be exercised to ensure that the prescribed dose of DHA does not exceed 1 gram (1,000 mg) per day. Since daily ingestion of more than 3 grams (3,000 mg) per day of omega-3 fatty acids (including alphalinolenic acid (ALA), eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)) from fish oils may have potential antithrombotic activities and may increase bleeding times, administration of DHA should be avoided in patients with inherited or acquired bleeding diatheses, including those taking anticoagulants.


  • STORAGE AND HANDLING

    Store at room temperature

    Keep out of reach of children


    Manufactured for:

    PruGen inc. Pharmaceuticals

    8714 E Vista Bonita Dr

    Scottsdale, AZ 85255


  • INGREDIENTS AND APPEARANCE
    BAL-CARE DHA ESSENTIAL 
    beta carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, sodium feredetate, magnesium oxide, zinc oxide, cupric oxide, iron sucrose, iodine, omega 3 fatty acids kit
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42546-185
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42546-185-30 6 in 1 CARTON
    1 1 in 1 BLISTER PACK
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 30 
    Part 2 30 
    Part 1 of 2
    BAL-CARE DHA ESSENTIAL 
    beta carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, sodium feredetate, magnesium oxide, zinc oxide, cupric oxide, iron sucrose, iodine, tablet
    Product Information
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BETA CAROTENE (UNII: 01YAE03M7J) (VITAMIN A - UNII:81G40H8B0T) BETA CAROTENE 2850 [iU]
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 120 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 840 [iU]
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL ACETATE, DL- - UNII:WR1WPI7EW8) .ALPHA.-TOCOPHEROL ACETATE, DL- 3 mg
    THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE - UNII:X66NSO3N35) THIAMINE MONONITRATE 1.8 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 4 mg
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 20 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE 50 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN .012 mg
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM - UNII:SY7Q814VUP) CALCIUM CARBONATE 219 mg
    SODIUM FEREDETATE (UNII: 403J23EMFA) (IRON - UNII:E1UOL152H7) SODIUM FEREDETATE 25.65 mg
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM - UNII:I38ZP9992A) MAGNESIUM OXIDE 25 mg
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC - UNII:J41CSQ7QDS) ZINC OXIDE 25 mg
    CUPRIC OXIDE (UNII: V1XJQ704R4) (COPPER - UNII:789U1901C5) CUPRIC OXIDE 2 mg
    IRON SUCROSE (UNII: FZ7NYF5N8L) (IRON - UNII:E1UOL152H7) IRON SUCROSE 1.35 mg
    IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE .223 mg
    Product Characteristics
    Color pink Score no score
    Shape OVAL Size 19mm
    Flavor Imprint Code 102
    Contains     
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 05/01/2012
    Part 2 of 2
    BAL-CARE DHA ESSENTIAL 
    omega 3 fatty acids capsule, liquid filled
    Product Information
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OMEGA-3 FATTY ACIDS (UNII: 71M78END5S) (OMEGA-3 FATTY ACIDS - UNII:71M78END5S) OMEGA-3 FATTY ACIDS 374 mg
    Product Characteristics
    Color brown Score no score
    Shape OVAL Size 24mm
    Flavor Imprint Code none
    Contains     
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    dietary supplement 05/01/2012
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 05/01/2012
    Labeler - PruGen, Inc. (929922750)