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PNV Prenatal Vitamins plus Vitamin A

Generic Name: alpha-tocopherol acetate, dl-, ascorbic acid, cholecalciferol, cyanocobalamin, folic acid, ferrous fumarate, calcium phosphate, dibasic, anhydrous, niacinamide, pyridoxine hydrochloride, riboflavin, thiamine mononitrate and vitamin a acetate
Dosage Form: tablet

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

Each PNV tablet contains:

VITAMINS:
Vitamin A (as acetate) 2500 IU
Vitamin C (as Ascorbic Acid) 60 mg
Vitamin D3 (as Cholecalciferol) 400 IU
Vitamin E (as Tocopheryl acetate) 15 IU
Vitamin B1 (as Thiamine Mononitrate) 1.05 mg
Vitamin B2 (as Riboflavin, USP) 1.2 mg
Niacin (as Niacinamide) 13.5 mg
Vitamin B6 (as Pyridoxine HCL) 1.05 mg
Folic Acid 1 mg
Vitamin B12 (as Cyanocobalamin) 4.5 mcg
MINERAL:
Iron (as ferrous fumarate) 27 mg
Calcium (as Dibasic Calcium Phosphate) 50 mg

OTHER INGREDIENTS

Microcrystalline Cellulose, Croscarmellose Sodium, Citric Acid, Talc and Magnesium Stearate.

DIRECTIONS

One tablet daily with a meal, or as directed by a physician.

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.

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: 12/07/12

PRINCIPAL DISPLAY PANEL - 400 Tablet Bottle Label

44946-1046-4
Rx only

PNV Prenatal Health
PNV
Prenatal Vitamins

FOLIC ACID + IRON
MULTIVITAMIN

PLUS VITAMIN A
Tablets

Provides vitamin and
mineral supplementation
throughout pregnancy
and postnatal period

Sugar & Gluten Free

SCI
Sancilio & Company, Inc

Developing good science into great medicine

400
TABLETS

PNV PRENATAL VITAMIN  PLUS VITAMIN A
.alpha.-tocopherol acetate, dl-, ascorbic acid, cholecalciferol, cyanocobalamin, folic acid, ferrous fumarate, calcium phosphate, dibasic, anhydrous, niacinamide, pyridoxine hydrochloride, riboflavin, thiamine mononitrate, and vitamin a acetate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:44946-1046
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- 15 [iU]
Ascorbic Acid (Ascorbic Acid) Ascorbic Acid 60 mg
Cholecalciferol (Cholecalciferol) Cholecalciferol 400 [iU]
Cyanocobalamin (Cyanocobalamin) Cyanocobalamin 4.5 ug
Folic Acid (Folic Acid) Folic Acid 1 mg
Ferrous fumarate (Ferrous cation) Ferrous cation 27 mg
Calcium Phosphate, Dibasic, Anhydrous (CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS) Calcium Phosphate, Dibasic, Anhydrous 50 mg
Niacinamide (Niacinamide) Niacinamide 13.5 mg
Pyridoxine Hydrochloride (Pyridoxine) Pyridoxine Hydrochloride 1.05 mg
Riboflavin (Riboflavin) Riboflavin 1.2 mg
Thiamine Mononitrate (Thiamine Ion) Thiamine 1.05 mg
Vitamin A Acetate (VITAMIN A) VITAMIN A 2500 [iU]
Inactive Ingredients
Ingredient Name Strength
Cellulose, Microcrystalline  
Croscarmellose sodium  
Anhydrous Citric Acid  
Talc  
Magnesium stearate  
Product Characteristics
Color BROWN (Light brown to brown-speckled) Score no score
Shape OVAL (capsule-shaped) Size 18mm
Flavor Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:44946-1046-0 30 TABLET in 1 BOTTLE, PLASTIC
2 NDC:44946-1046-2 90 TABLET in 1 BOTTLE, PLASTIC
3 NDC:44946-1046-4 400 TABLET in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 12/07/2012
Labeler - Sancilio & Company Inc (176681257)
Revised: 12/2012
 
Sancilio & Company Inc
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