Medication Guide App

Vitaphil and DHA

Generic Name: prenatal multivitamin and minerals
Dosage Form: 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.

VITAPHIL + DHA

DESCRIPTION:

VitaPhil + DHA and VitaPhil + DHA 90 are high-potency, multivitamin, multi-mineral nutritional supplements with DHA (Omega-3 Fatty Acid).

Each VitaPhil + DHA and VitaPhil + DHA 90 caplet contains:

Amount Per Serving
% Daily Value
Vitamin A (as beta carotene)
2600 IU
52%
Vitamin C (as ascorbic acid)
120 mg
200%
Vitamin D3 (cholecalciferol)
420 IU
105%
Vitamin E (as d-alpha tocopheryl succinate)
20 IU
67%
Vitamin B1 (as thiamine HCl)
3 mg
200%
Vitamin B2 (as riboflavin)
3.5 mg
205%
Vitamin B3 (as niacinamide)
20 mg
100%
Vitamin B6 (as pyridoxine HCl)
30 mg
1500%
Folic Acid
1 mg
250%
Vitamin B12 (as cyanocobalamin)
12 mcg
200%
Biotin
30 mcg
10%
Pantothenic Acid (as calcium pantothenate)
8 mg
80%
Calcium (as calcium carbonate and tricalcium phosphate)
100 mg
10%
Iron (as ferrous bisglycinate)
26 mg
144%
Magnesium (as magnesium oxide)
50 mg
12%
Zinc (as zinc oxide)
15 mg
100%
Selenium (as sodium selenate)
50 mcg
71%
Copper (as cupric oxide)
2 mg
100%
Choline (as choline bitartrate)
60 mg
*
*Daily Value not established.


Other Ingredients (VitaPhil + DHA and VitaPhil + DHA 90 caplet): Microcrystalline Cellulose, Croscarmellose Sodium, Crospovidone, Silicon Dioxide, Magnesium Stearate, Stearic Acid, Maltodextrin, Dicalcium Phosphate, Sodium Alginate, Hydroxypropyl Methylcellulose, Polyethylene Glycol, Sucrose, Gelatin, Corn Starch, Acacia, Arabic Gum, Pea Starch, dl-Alpha Tocopherol, Hydrogenated Soybean Oil, Triacetin, Titanium Dioxide, FD&C Blue 1 Aluminum Lake, FD&C Yellow 5 Aluminum Lake, Polysorbate 80.

Contains Soy.

Each VitaPhil + DHA and VitaPhil + DHA 90 softgel capsule contains:

Amount Per Serving
% Daily Value
Docosahexaenoic Acid (DHA)
200 mg
*
*Daily Value not established.


Other Ingredients (VitaPhil + DHA and VitaPhil + DHA 90 Softgel Capsules): Gelatin, Water, Glycerin, Polysorbate 80.

May contain Vanillin.

Also contains Eicosapentaenoic Acid (EPA) and other Omega-3 Fatty Acids (from tuna oil).

Cloudiness of the softgel capsule is a characteristic of natural fish oil.

Contains Soy.


Contains NO artificial flavors or preservatives, yeast, wheat, gluten, nuts or milk-based by-products.

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

VitaPhil + DHA and VitaPhil + DHA 90 supply important prenatal vitamins, minerals and nutrients to supplement the nutritional needs of women, before, during and after pregnancy. Deficiencies of these nutrients are common during pregnancy and lactation and should be prescribed by a physician prior to conception.

VitaPhil + DHA and VitaPhil + DHA 90 caplets are manufactured in a drug-certified cGMP (current good manufacturing practices) facility and meets or exceeds USP standards for potency, purity and dissolution. VitaPhil + DHA and VitaPhil + DHA 90 softgel capsules comply with the most stringent worldwide standards for fish oil and are manufactured in a NSF Certified cGMP Facility.

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.

WARNING:

Folic acid alone is improper therapy in the treatment of pernicious anemia in that hematological remission can occur while neurological manifestations remain progressive.

Ingestion of omega-3 fatty acids (including alpha-linolenic acid [ALA], eicosapentaenoic acid [EPA] and docosahexaenoic acid [DHA] from fish oils) of more than 3 grams per day may present antithrombotic effects, including increased bleeding time. Omega-3 fatty acids including DHA and EPA should be avoided in patients with inherited or acquired bleeding diatheses. Patients taking anticoagulant drug products should consult with their physician prior to ingesting omega-3 fatty acids.

PRECAUTIONS:

Folic acid in dosages above 400 mcg daily may obscure megaloblastic (pernicious) anemia in that hematological remission can occur while neurological manifestations (Addisonian anemia) remain progressive.

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.

USE IN SPECIFIC POPULATIONS:

VitaPhil + DHA and VitaPhil + DHA 90 are not advocated for pediatric or geriatric use.

OVERDOSE:

Iron: Signs and Symptoms: Iron is toxic. Acute overdosage of iron may cause nausea and vomiting. In severe cases, iron overdose can cause cardiovascular collapse and death. Other symptoms include pallor and cyanosis, melena, shock, drowsiness and coma. The estimated overdose of orally ingested iron is 300mg/kg body weight. When overdoses are ingested by children, severe reactions, including fatalities have resulted. VitaPhil + DHA and VitaPhil + DHA 90 should be stored beyond the reach of children to prevent against accidental iron poisoning. Keep this and all other drugs out of reach of children. Treatment: For specific therapy, exchange transfusion and chelating agents should be used. For general management, perform gastric lavage with sodium bicarbonate solution or milk. Administer intravenous fluids and electrolytes and use oxygen.

HOW SUPPLIED:

VitaPhil + DHA (NDC 68032-341-60): A 30-day regimen supplied as one bottle containing 30 green VitaPhil + DHA Prenatal capsule-shaped caplets NDC: 68032-496-30 imprinted “RE 341” and one bottle containing 30 pale yellow DHA softgel capsules NDC: 68032-497-30. Dispense in tight, light-resistant containers as defined in the USP/NF with child resistant closures.

VitaPhil + DHA 90 (NDC 68032-342-18): A 90-day regimen supplied as one bottle containing 90 green VitaPhil + DHA 90 Prenatal capsule-shaped caplets NDC: 68032-498-90 imprinted “RE 341” and one bottle containing 90 pale yellow DHA softgel capsules NDC: 68032-499-90. Dispense in tight, light-resistant containers as defined in the USP/NF with child resistant closures.

Store at controlled room temperature 15°-30°C (59°-86°F). Keep in a cool, dry place.

CAUTION: Rx Only

Manufactured for:

River’s Edge Pharmaceuticals, LLC
Suwanee, GA 30024
Iss. 03/10   341/342-11

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



Hide
(web1)