Bal-Care DHA Essential

Generic Name: vitamin and mineral supplement
Dosage Form: tablet / softgel capsule

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.

Bal-Care DHA Essential Rev 1.0

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




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.


 

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.

Store at room temperature

Keep out of reach of children


Manufactured for:

PruGen inc. Pharmaceuticals

8714 E Vista Bonita Dr

Scottsdale, AZ 85255

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 LABEL Item Code (Source) NDC:42546-185
Packaging
# Item Code Package Description
1 NDC:42546-185-30 6 BLISTER PACK (BLISTER PACK) in 1 CARTON
1 1 KIT (KIT) 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 DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETA CAROTENE (VITAMIN A) BETA CAROTENE 2850 [iU]
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 120 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 840 [iU]
.ALPHA.-TOCOPHEROL ACETATE, DL- (.ALPHA.-TOCOPHEROL ACETATE, DL-) .ALPHA.-TOCOPHEROL ACETATE, DL- 3 mg
THIAMINE MONONITRATE (THIAMINE) THIAMINE MONONITRATE 1.8 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 4 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 20 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 50 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN .012 mg
CALCIUM CARBONATE (CALCIUM) CALCIUM CARBONATE 219 mg
SODIUM FEREDETATE (IRON) SODIUM FEREDETATE 25.65 mg
MAGNESIUM OXIDE (MAGNESIUM) MAGNESIUM OXIDE 25 mg
ZINC OXIDE (ZINC) ZINC OXIDE 25 mg
CUPRIC OXIDE (COPPER) CUPRIC OXIDE 2 mg
IRON SUCROSE (IRON) IRON SUCROSE 1.35 mg
IODINE (IODINE) 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 DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OMEGA-3 FATTY ACIDS (OMEGA-3 FATTY ACIDS) 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)
Revised: 05/2012
 
PruGen, Inc.



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