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

PNV Prenatal Vitamin by

Drug Labeling and Warnings

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

Drug Details [pdf]

STATEMENT OF IDENTITY

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.

STATEMENT OF IDENTITY

Each fruit-flavored PNV Chewable tablet contains:

• 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
• 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 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.

HEALTH CLAIM

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 Tablets Bottle Label

44946-1041-5

PNV Prenatal Health
PNV
Prenatal Vitamins

FOLIC ACID + IRON
MULTIVITAMIN
Chewable
Tablets

Dispense under a
physician's order†

Dietary Supplement

Sugar Free

SCI
Sancilio & Company, Inc
Developing Good Science into Great Medicine

90
TABLETS

INGREDIENTS AND APPEARANCE

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	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:44946-1041
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-	11 [iU]
Cholecalciferol (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41)	Cholecalciferol	400 [iU]
Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204)	Cyanocobalamin	12 ug
Ferrous fumarate (UNII: R5L488RY0Q) (Ferrous cation - UNII:GW89581OWR)	Ferrous cation	29 mg
Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8)	Folic Acid	1 mg
Niacinamide (UNII: 25X51I8RD4) (Niacinamide - UNII:25X51I8RD4)	Niacinamide	20 mg
Sodium Ascorbate (UNII: S033EH8359) (Ascorbic Acid - UNII:PQ6CK8PD0R)	Ascorbic Acid	60 mg
Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R)	Ascorbic Acid	60 mg
Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z)	Pyridoxine	10 mg
Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR)	Riboflavin	3 mg
Thiamine Mononitrate (UNII: 8K0I04919X) (Thiamine Ion - UNII:4ABT0J945J)	Thiamine	2 mg

Inactive Ingredients
Ingredient Name	Strength
Xylitol (UNII: VCQ006KQ1E)
Microcrystalline Cellulose (UNII: OP1R32D61U)
Malic Acid (UNII: 817L1N4CKP)
Talc (UNII: 7SEV7J4R1U)
Magnesium stearate (UNII: 70097M6I30)
Sucralose (UNII: 96K6UQ3ZD4)
Anhydrous Citric Acid (UNII: XF417D3PSL)
Tocopherol (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:44946-1041-5	90 in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
DIETARY SUPPLEMENT		12/20/2011

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
scoring	1
shape
size (solid drugs)	16 mm
imprint
flavor

Labeler - Sancilio & Company Inc (176681257)