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PNV Prenatal Vitamins

Generic Name: alpha-tocopherol acetate, dl-, cholecalciferol, cyanocobalamin, ferrous fumarate, folic acid, niacinamide, sodium ascorbate, ascorbic acid, pyridoxine hydrochloride, riboflavin and thiamine mononitrate
Dosage Form: tablet, chewable

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.

PNV Prenatal Health™ - Prenatal Vitamins

PNV Chewable Tablets are formulated to provide vitamin and mineral supplementation throughout pregnancy and during the postnatal period, for both the lactating and non-lactating mothers, and is useful for improving nutritional status prior to conception.

Each fruit-flavored PNV Chewable tablet contains:

VITAMINS:
Vitamin C (as sodium ascorbate and ascorbic acid) 120 mg
Vitamin D3 (as cholecalciferol) 400 IU
Vitamin E (as dl-alpha tocopheryl acetate) 11 IU
Vitamin B1 (as thiamin mononitrate) 2 mg
Vitamin B2 (as riboflavin) 3 mg
Vitamin B3 (as niacinamide) 20 mg
Vitamin B6 (as pyridoxine HCL) 10 mg
Vitamin Folic Acid 1 mg
Vitamin B12 (as cyanocobalamin) 12 mcg
MINERAL:
Iron (as ferrous fumarate) 29 mg

OTHER INGREDIENTS

Microcrystalline cellulose, xylitol, magnesium stearate, talc, natural fruit flavor, malic acid, sucralose, citric acid, and mixed tocopherols.

DIRECTIONS

One tablet daily with a meal, or as directed by a physician. Tablets should be chewed or crushed before swallowing.

CAUTION

Folic acid may partially correct the hematological damage due to vitamin B12 deficiency of pernicious anemia, while the associated neurological damage progresses.

Warning

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

Adverse Reactions

In some cases, allergic hypersensitivity has been reported following administration of folic acid. Mild gastrointestinal disturbances may occur with products containing ferrous fumarate (iron), but usually subside with continuation of therapy.

How is PNV Prenatal Vitamins Supplied

PNV Prenatal Health™ - Prenatal Vitamins are light brown to brown-speckled, fruit-flavored, round tablets debossed "SCI" on one side.

STORE AT CONTROLLED ROOM TEMPERATURE 15°-30°C (59°-86°F).

PROTECT FROM EXCESS HEAT AND MOISTURE. Dispense in a tight, light-resistant container with child-resistant closure.

This medical food product is formulated to be administered orally, under the supervision of a physician and is intended for the management of a dietary deficiency of folic acid and iron for which a distinctive nutritional requirement, based on recognized scientific principles, has been established by medical evaluation. The numeric identifier on this product's labeling is an assigned product code for use with pharmacy-level, health insurance and state level reimbursement programs and is not intended to denote registration or approval from the FDA.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

DO NOT USE IF INNER SAFETY SEAL IS BROKEN OR MISSING.

Manufactured by: Sancilio & Company, Inc.,
Riviera Beach, FL 33404
(800) SCI-8711

© 2011 Sancilio & Company, Inc.

REV: 12/06/11

PRINCIPAL DISPLAY PANEL - 90 Tablet Bottle Label

44946-1041-5
Rx only

PNV Prenatal Health
PNV
Prenatal Vitamins

FOLIC ACID + IRON
MULTIVITAMIN

Chewable
Tablets

Provides vitamin and
mineral supplementation
throughout pregnancy
and postnatal period

Sugar Free

SCI
Sancilio & Company, Inc

Developing good science into great medicine

90
TABLETS

PNV PRENATAL VITAMIN 
.alpha.-tocopherol acetate, dl-, cholecalciferol, cyanocobalamin, ferrous fumarate, folic acid, niacinamide, sodium ascorbate, ascorbic acid, pyridoxine hydrochloride, riboflavin, and thiamine mononitrate tablet, chewable
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:44946-1041
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
.Alpha.-Tocopherol Acetate, DL- (.Alpha.-Tocopherol, DL-) .Alpha.-Tocopherol, DL- 11 [iU]
Cholecalciferol (Cholecalciferol) Cholecalciferol 400 [iU]
Cyanocobalamin (Cyanocobalamin) Cyanocobalamin 12 ug
Ferrous fumarate (Ferrous cation) Ferrous cation 29 mg
Folic Acid (Folic Acid) Folic Acid 1 mg
Niacinamide (Niacinamide) Niacinamide 20 mg
Sodium Ascorbate (Ascorbic Acid) Sodium Ascorbate 60 mg
Ascorbic Acid (Ascorbic Acid) Ascorbic Acid 60 mg
Pyridoxine Hydrochloride (Pyridoxine) Pyridoxine 10 mg
Riboflavin (Riboflavin) Riboflavin 3 mg
Thiamine Mononitrate (Thiamine Ion) Thiamine 2 mg
Inactive Ingredients
Ingredient Name Strength
Xylitol  
Cellulose, Microcrystalline  
Malic Acid  
Talc  
Magnesium stearate  
Sucralose  
Anhydrous Citric Acid  
Product Characteristics
Color BROWN (Light brown to brown-speckled) Score no score
Shape ROUND Size 16mm
Flavor FRUIT Imprint Code SCI
Contains         
Packaging
# Item Code Package Description
1 NDC:44946-1041-5 90 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 12/20/2011
Labeler - Sancilio & Company Inc (176681257)
Revised: 12/2012
 
Sancilio & Company Inc
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