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Name:Vitaphil
Manufacturer:River's Edge Pharmaceuticals, Llc
Category:Prescription Marketed Drugs


VitaPhil + DHA 90

VITAPHIL   - vitaphil dha 90   
River's Edge Pharmaceuticals, LLC

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.

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VitaPhil + DHA 90

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:

facts1

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

Contains Soy.

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

200 mg Docosahexaenoic Acid (DHA)

facts2

Other Ingredients (VitaPhil + DHA and VitaPhil + DHA 90): Gelatin, Water, Glycerin, Polysorbate 80.
Also contains Eicosapentaenoic Acid (EPA) and other Omega-3 Fatty Acids (from tuna 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 softgels 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 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.

WARNINGS:

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

VitaPhil + DHA 90: A 90-day regimen supplied as one bottle containing 90 green VitaPhil + DHA 90 Prenatal capsule-shaped caplets imprinted “RE 341” and one bottle containing 90 pale yellow DHA softgels. NDC: 68032-342-18. 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
Iss. 10/08
341/342-11

PACKAGING:

Carton:

carton


VITAPHIL  
vitaphil dha 90 kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68032-342
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68032-342-18 1 KIT ( KIT) in 1 CARTON None
QUANTITY OF PARTS
Part # Package Quantity Total Product Quantity
Part 1 1 BOTTLE   90 
Part 2 1 BOTTLE   90 
Part 1 of 2
VITALPHIL 
vitaphil tablet
Product Information
Item Code (Source) NDC:68032-342
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 CATION) CALCIUM PANTOTHENATE 8 mg
CALCIUM CARBONATE (CALCIUM CATION) CALCIUM CARBONATE 100 mg
IRON (IRON) IRON 26 mg
MAGNESIUM OXIDE (MAGNESIUM) MAGNESIUM OXIDE 50 mg
ZINC OXIDE (ZINC) ZINC OXIDE 15 mg
SELENIUM (SELENIUM) SELENIUM 50 ug
CUPRIC OXIDE (CUPRIC CATION) CUPRIC OXIDE 2 mg
Product Characteristics
Color green Score no score
Shape CAPSULE Size 20mm
Flavor Imprint Code RE;341
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 68032-342-90 90 TABLET ( TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 10/01/2008

Part 2 of 2
VITAPHIL  
vitaphil dha capsule
Product Information
Item Code (Source) NDC:68032-342
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOCONEXENT (DOCONEXENT) DOCONEXENT 200 mg
Product Characteristics
Color yellow Score no score
Shape CAPSULE Size 20mm
Flavor Imprint Code RE;342
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 68032-342-90 90 CAPSULE ( TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 10/01/2008


Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 10/01/2008

Labeler - River's Edge Pharmaceuticals, LLC (133879135)

Revised: 12/2009 River's Edge Pharmaceuticals, LLC



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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