Bal-Care DHA

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:
430 mg purified omega-3 fatty acids including:
At least 295 mg DHA (docosahexaenoic acid); also contains at least 135 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  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:42546-180

Packaging # Item Code Package Description 1 NDC:42546-180-30 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  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  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 430 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.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Black, tarry, or bloody stools.
• Fever.
• Very upset stomach or throwing up.
• Very bad belly pain.
• Throwing up blood or throw up that looks like coffee grounds.
• Stomach cramps.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Hard stools (constipation).
• Upset stomach or throwing up.
• Change in color of stool to green.
• Loose stools (diarrhea).
• Belly pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Some side effects of Bal-Care DHA may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.