PNV OB DHA

PNV OB DHA — vitamin c, calcium, iron, vitamin d3, vitamin e, vitamin b1, vitamin b2, vitamin b3, vitamin b6, folic acid, iodine, zinc, copper, docusate sodium, docosahexaenoic acid (dha)
PureTek Corporation

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.

DESCRIPTION:

PharmaPure Rx PNV OB + DHA is a prescription prenatal/postnatal multivitamin/mineral caplet and a softgel of an essential fatty acid. The prenatal vitamin is a light purple, capsule-shaped multivitamin/mineral caplet. The caplet is imprinted with the code “P-116″ on one side and is blank on the other side. The essential fatty acid DHA softgel is clear and contains a pale yellow semi-solid mixture.

Each PNV OB+DHA caplet contains:
Vitamin C (Ascorbic acid) 120 mg
Calcium (Calcium citrate) 125 mg
Iron (Carbonyl iron, Ferrous gluconate)27 mg
Vitamin D3 (Cholecalciferol) 400 IU
Vitamin E (dl-alpha tocopheryl acetate)30 IU
Vitamin B1 (Thiamine HCl) 3 mg
Vitamin B2 (Riboflavin)3.4 mg
Vitamin B3 (Niacinamide)20 mg
Vitamin B6 (Pyridoxine HCl) 20 mg
Folic Acid 1 mg
Iodine (Potassium iodide) 150 mcg
Zinc (Zinc oxide)25 mg
Copper (Cupric oxide) 2 mg
Docusate Sodium 50 mg

Other ingredients in DHA caplet: Croscarmellose Sodium, Crospovidone, FD and C Blue #2 Aluminum Lake, Gelatin, Hydrogenated Soybean Oil, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polydextrose, Polyethylene Glycol, Polysorbate 80, Povidone, Red Iron Oxide, Silicon Dioxide, Starch, Stearic Acid, Sucrose, Titanium Dioxide, Triacetin.

Each PNV OB+DHA softgel contains:
250 mg Docosahexaenoic Acid (DHA)
Supplement Facts
Serving Size: 1 Softgel %Daily Value
Docosahexaenoic Acid (DHA) 250 mg*
*Daily Value not established.

DHA is contained in the oil derived from fish (tuna). Other ingredients in DHA softgel:Gelatin, Water, Glycerin, Polysorbate 80.
May contain Vanillin.
Also contains Eicosapentaenoic Acid (EPA) and other omega-3 fatty acids.
Cloudiness of the softgel is a characteristic of natural fish oil.
Contains Soy.
Docusate sodium is a gentle and effective stool softener that protects against the discomfort of constipation.
Contains NO artificial flavors or preservatives, yeast, wheat, gluten, nuts or milk-based by-products.
PNV OB+DHA supplies 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.
PNV OB+DHA caplet is manufactured in a drug registered cGMP (current good manufacturing practice) facility and meets or exceeds USP standards for potency, purity and dissolution. PNV OB+DHA softgel complies with the most stringent worldwide standards for fish oil and is manufactured in a NSF-Certified cGMP Facility.

INDICATIONS AND USAGE:

PNV OB+DHA is a multivitamin/mineral prescription drug indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and nonlactating mothers.

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 may be taken together or at different times of the day.

CONTRAINDICATIONS:

PNV OB+DHA is contraindicated in patients with a known hypersensitivity to any of the ingredients.

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.

Ingestion of more than 3 grams of omega-3 fatty acids per day has been shown to have potential antithrombotic effects, including increased bleeding time and reduced clotting ratio (INR). Administration of omega-3 fatty acids should be avoided in patients on anticoagulants and in those known to have an inherited or acquired bleeding diathesis. Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.

PRECAUTIONS:

Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

Exercise caution to ensure that the prescribed dosage of DHA doses not exceed 1 gram (1,000 mg) per day.


NOTICE: Contact with moisture can discolor or erode the caplet.

ADVERSE REACTIONS:

Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
Caution should be exercised with patients with known allergies to fish or fish by-products.

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:

PNV OB+DHA is not indicated for pediatric or geriatric use.

HOW SUPPLIED:

PNV OB+DH A (NDC 59088-115-60) is a 30-day regimen supplied as six child-resistant blister cards each containing 5 light purple PNV OB+DHA prenatal capsule-shaped caplets NDC:59088-116-54 imprinted “P-116″ and 5 pale yellow DHA softgels NDC: 59088-117-54 each.

Store at temperature 20°-25°C (68°-77°F).[See USP Controlled Room Temperature]. Keep in a cool, dry place.

Carton

image of carton
(click image for full-size original)

PNV OB DHA vitamin c, calcium, iron, vitamin d3, vitamin e, vitamin b1, vitamin b2, vitamin b3, vitamin b6, folic acid, iodine, zinc, copper, docusate sodium, docosahexaenoic acid (dha) kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59088-115
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59088-115-60 6 BLISTER PACK (BLISTER PACK) in 1 CARTON contains a BLISTER PACK
1 1 KIT (KIT) in 1 BLISTER PACK This package is contained within the CARTON (59088-115-60)
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 5
Part 2 5
Part 1 of 2
PRENATAL VITAMIN vitamin c, calcium, iron, vitamin d3, vitamin e, vitamin b1, vitamin b2, vitamin b3, vitamin b6, folic acid, iodine, zinc, copper, docusate sodium tablet
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 120 mg
CALCIUM CITRATE (CALCIUM) CALCIUM 125 mg
FERROUS GLUCONATE (IRON) IRON 0.1 mg
IRON PENTACARBONYL (IRON) IRON PENTACARBONYL 26.9 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU]
.ALPHA.-TOCOPHEROL ACETATE, DL- (ALPHA-TOCOPHEROL) ALPHA-TOCOPHEROL 30 [iU]
THIAMINE HYDROCHLORIDE (THIAMINE) THIAMINE HYDROCHLORIDE 3 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 3.4 mg
NIACINAMIDE (NIACIN) NIACIN 20 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 20 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
POTASSIUM IODIDE (POTASSIUM CATION) POTASSIUM CATION 150 ug
ZINC OXIDE (ZINC) ZINC 25 mg
CUPRIC OXIDE (COPPER) CUPRIC OXIDE 2 mg
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 50 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
CROSPOVIDONE
FD&C BLUE NO. 2
GELATIN
HYDROGENATED SOYBEAN OIL
HYPROMELLOSE 2910 (15 MPA.S)
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYDEXTROSE
POLYETHYLENE GLYCOL 8000
SILICON DIOXIDE
STARCH, CORN
STEARIC ACID
SUCROSE
TITANIUM DIOXIDE
TRIACETIN
POLYSORBATE 80
FERRIC OXIDE RED
Product Characteristics
Color purple (Light purple) Score no score
Shape CAPSULE (capsule-shaped caplets) Size 21mm
Flavor Imprint Code P116
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 06/01/2011
Part 2 of 2
DHA docosahexaenoic acid capsule, gelatin coated
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOCONEXENT (DOCONEXENT) DOCONEXENT 250 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN
WATER
GLYCERIN
POLYSORBATE 80
Product Characteristics
Color yellow (pale yellow) Score no score
Shape CAPSULE (Softgel) Size 21mm
Flavor Imprint Code NONE
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 06/01/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 06/01/2011
Labeler — PureTek Corporation (785961046)
Establishment
Name Address ID/FEI Operations
PureTek Corporation 785961046 manufacture, label, pack, outsourcing human drug compounding, relabel, repack

Revised: 07/2011 PureTek Corporation

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