PNV Prenatal Vitamin description, usages, side effects, indications, overdosage, supplying and lots more!

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PNV Prenatal Vitamin

Sancilio & Company Inc

PNV Prenatal Health™ - Prenatal Vitamins


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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.

PNV PRENATAL VITAMIN 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.

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

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- 11 [iU]
CHOLECALCIFEROL CHOLECALCIFEROL 400 [iU]
Cyanocobalamin CYANOCOBALAMIN 12 ug
FERROUS FUMARATE FERROUS CATION 29 mg
FOLIC ACID FOLIC ACID 1 mg
NIACINAMIDE 20 mg
sodium ascorbate ASCORBIC ACID 60 mg
ASCORBIC ACID ASCORBIC ACID 60 mg
PYRIDOXINE HYDROCHLORIDE PYRIDOXINE 10 mg
RIBOFLAVIN RIBOFLAVIN 3 mg
THIAMINE MONONITRATE THIAMINE ION 2 mg

Inactive Ingredients

Ingredient Name Strength
Xylitol
cellulose, microcrystalline
Malic Acid
talc
MAGNESIUM STEARATE
Sucralose
ANHYDROUS CITRIC ACID

Product Characteristics

Color Size Imprint Code Shape
BROWN (Light brown to brown-speckled) 16 mm SCI ROUND

Packaging

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

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2011-12-20


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