Vitaphil and DHA

Name: Vitaphil and DHA

Indications and usage

VitaPhil + DHA and VitaPhil + DHA 90 are indicated to provide vitamin/mineral and omega-3 fatty acid supplementation to women throughout pregnancy, during the postnatal period for both lactating and non-lactating mothers and throughout the child bearing years. VitaPhil + DHA and VitaPhil + DHA 90 are also useful in improving the nutritional status prior to conception.

Dosage and administration

Before, during and after pregnancy, one caplet and one softgel capsule taken by mouth daily, or as prescribed by a physician. The caplet and softgel capsule may be taken together or at different times of the day. Caution should be exercised to ensure that the prescribed dose of DHA does not exceed 1 gram (1,000 mg) per day.

Contraindications

VitaPhil + DHA and VitaPhil + DHA 90 are contraindicated in patients with a known hypersensitivity to any of the ingredients, including fish oil and soy. Iron is contraindicated in patients with hemosiderosis, hemochromatosis, or hemolytic anemias. These products are contraindicated for persons with pernicious anemia, as folic acid may obscure its signs and symptoms.

Adverse reactions

Iron: Gastrointestinal disturbances (anorexia, nausea, diarrhea, constipation) can occur but are usually mild and can subside with continuation of therapy. Although the absorption of iron is best when taken between meals, VitaPhil + DHA and VitaPhil + DHA 90 when taken after meals, may control occasional G.I. disturbances. VitaPhil + DHA and VitaPhil + DHA 90 are best absorbed when taken at bedtime.
Folic Acid: Allergic sensitizations have been reported following both oral and parenteral administration of folic acid.

Call your doctor for medical advice about side effects. You may report suspected side effects to the FDA at 1-800-FDA-1088.

Packaging

VITAPHIL DHA 
beta carotene, ascorbic acid, cholecalciferol, alpha-tocopherol, thiamine hydrochloride, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium pantothenate, calcium carbonate, iron, magnesium oxide, zinc oxide, selenium, cupric oxide, choline bitartrate, doconexent kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68032-341
Packaging
# Item Code Package Description
1 NDC:68032-341-60 1 KIT (KIT) in 1 CARTON
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 BOTTLE 30 
Part 2 1 BOTTLE 30 
Part 1 of 2
VITAPHIL 
beta carotene, ascorbic acid, cholecalciferol, alpha-tocopherol, thiamine hydrochloride, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium pantothenate, calcium carbonate, iron, magnesium oxide, zinc oxide, selenium, cupric oxide, choline bitartrate tablet
Product Information
Item Code (Source) NDC:68032-496
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETA CAROTENE (BETA CAROTENE) BETA CAROTENE 2600 [iU]
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 120 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 420 [iU]
ALPHA-TOCOPHEROL (ALPHA-TOCOPHEROL) ALPHA-TOCOPHEROL 20 [iU]
THIAMINE HYDROCHLORIDE (THIAMINE) THIAMINE HYDROCHLORIDE 3 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 3.5 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 20 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 30 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 12 ug
BIOTIN (BIOTIN) BIOTIN 30 ug
CALCIUM PANTOTHENATE (CALCIUM) CALCIUM PANTOTHENATE 8 mg
CALCIUM CARBONATE (CALCIUM) CALCIUM CARBONATE 100 mg
IRON (IRON) IRON 26 mg
MAGNESIUM OXIDE (MAGNESIUM OXIDE) MAGNESIUM OXIDE 50 mg
ZINC OXIDE (ZINC) ZINC OXIDE 15 mg
SELENIUM (SELENIUM) SELENIUM 50 ug
CUPRIC OXIDE (COPPER) CUPRIC OXIDE 2 mg
CHOLINE BITARTRATE (CHOLINE) CHOLINE BITARTRATE 60 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE  
CROSCARMELLOSE SODIUM  
CROSPOVIDONE  
SILICON DIOXIDE  
MAGNESIUM STEARATE  
STEARIC ACID  
MALTODEXTRIN  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE  
SODIUM ALGINATE  
HYPROMELLOSE 2208 (100 MPA.S)  
POLYETHYLENE GLYCOL  
SUCROSE  
GELATIN  
STARCH, CORN  
ACACIA  
ALPHA-TOCOPHEROL, DL-  
SOYBEAN OIL  
TRIACETIN  
TITANIUM DIOXIDE  
FD&C BLUE NO. 1  
FD&C YELLOW NO. 5  
POLYSORBATE 80  
Product Characteristics
Color green Score no score
Shape CAPSULE Size 20mm
Flavor Imprint Code RE;341
Contains     
Packaging
# Item Code Package Description
1 NDC:68032-496-30 30 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 11/14/2008 12/31/2011
Part 2 of 2
VITAPHIL DHA 
doconexent capsule, liquid filled
Product Information
Item Code (Source) NDC:68032-497
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOCONEXENT (DOCONEXENT) DOCONEXENT 200 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN  
WATER  
GLYCERIN  
POLYSORBATE 80  
Product Characteristics
Color yellow (Pale Yellow) Score no score
Shape CAPSULE Size 20mm
Flavor Imprint Code RE;499
Contains     
Packaging
# Item Code Package Description
1 NDC:68032-497-30 30 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 11/14/2008 12/31/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 11/14/2008 12/31/2011
Labeler - River's Edge Pharmaceuticals, LLC (133879135)
Revised: 12/2010   River's Edge Pharmaceuticals, LLC
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