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

PNV Prenatal Vitamin by

Drug Labeling and Warnings

PNV Prenatal Vitamin by is a Prescription medication manufactured, distributed, or labeled by Sancilio & Company Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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.

DESCRIPTION

Each PNV tablet contains:

• 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
• 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.

BOXED WARNING

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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 SUPPLIED

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.

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

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	Item Code (Source)	NDC: 44946-1046
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
.Alpha.-Tocopherol Acetate, DL- (UNII: WR1WPI7EW8) (.Alpha.-Tocopherol, DL- - UNII:7QWA1RIO01)	.Alpha.-Tocopherol, DL-	15 [iU]
Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R)	Ascorbic Acid	60 mg
Cholecalciferol (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41)	Cholecalciferol	400 [iU]
Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204)	Cyanocobalamin	4.5 ug
Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8)	Folic Acid	1 mg
Ferrous fumarate (UNII: R5L488RY0Q) (Ferrous cation - UNII:GW89581OWR)	Ferrous cation	27 mg
Calcium Phosphate, Dibasic, Anhydrous (UNII: L11K75P92J) (CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS - UNII:L11K75P92J)	Calcium Phosphate, Dibasic, Anhydrous	50 mg
Niacinamide (UNII: 25X51I8RD4) (Niacinamide - UNII:25X51I8RD4)	Niacinamide	13.5 mg
Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z)	Pyridoxine Hydrochloride	1.05 mg
Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR)	Riboflavin	1.2 mg
Thiamine Mononitrate (UNII: 8K0I04919X) (Thiamine Ion - UNII:4ABT0J945J)	Thiamine	1.05 mg
Vitamin A Acetate (UNII: 3LE3D9D6OY) (VITAMIN A - UNII:81G40H8B0T)	VITAMIN A	2500 [iU]

Inactive Ingredients
Ingredient Name	Strength
Cellulose, Microcrystalline (UNII: OP1R32D61U)
Croscarmellose sodium (UNII: M28OL1HH48)
Anhydrous Citric Acid (UNII: XF417D3PSL)
Talc (UNII: 7SEV7J4R1U)
Magnesium stearate (UNII: 70097M6I30)

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	Marketing Start Date	Marketing End Date
1	NDC: 44946-1046-0	30 in 1 BOTTLE, PLASTIC
2	NDC: 44946-1046-2	90 in 1 BOTTLE, PLASTIC
3	NDC: 44946-1046-4	400 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)