Label: 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

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated May 1, 2012

If you are a consumer or patient please visit this version.

  • 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

  • PRINCIPAL DISPLAY PANEL

    image of box
  • 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 TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:42546-185
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42546-185-306 in 1 CARTON
    11 in 1 BLISTER PACK
    Quantity of Parts
    Part #Package QuantityTotal 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 AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BETA CAROTENE (UNII: 01YAE03M7J) (VITAMIN A - UNII:81G40H8B0T) BETA CAROTENE2850 [iU]
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID120 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL840 [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 MONONITRATE1.8 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN4 mg
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE20 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE50 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN.012 mg
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM - UNII:SY7Q814VUP) CALCIUM CARBONATE219 mg
    SODIUM FEREDETATE (UNII: 403J23EMFA) (IRON - UNII:E1UOL152H7) SODIUM FEREDETATE25.65 mg
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM - UNII:I38ZP9992A) MAGNESIUM OXIDE25 mg
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC - UNII:J41CSQ7QDS) ZINC OXIDE25 mg
    CUPRIC OXIDE (UNII: V1XJQ704R4) (COPPER - UNII:789U1901C5) CUPRIC OXIDE2 mg
    IRON SUCROSE (UNII: FZ7NYF5N8L) (IRON - UNII:E1UOL152H7) IRON SUCROSE1.35 mg
    IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE.223 mg
    Product Characteristics
    ColorpinkScoreno score
    ShapeOVALSize19mm
    FlavorImprint Code 102
    Contains    
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/01/2012
    Part 2 of 2
    BAL-CARE DHA ESSENTIAL 
    omega 3 fatty acids capsule, liquid filled
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OMEGA-3 FATTY ACIDS (UNII: 71M78END5S) (OMEGA-3 FATTY ACIDS - UNII:71M78END5S) OMEGA-3 FATTY ACIDS374 mg
    Product Characteristics
    ColorbrownScoreno score
    ShapeOVALSize24mm
    FlavorImprint Code none
    Contains    
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    dietary supplement05/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/01/2012
    Labeler - PruGen, Inc. (929922750)