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 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.

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.

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

PNV Prenatal Vitamin

.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- 15 [iU]
ASCORBIC ACID ASCORBIC ACID 60 mg
CHOLECALCIFEROL CHOLECALCIFEROL 400 [iU]
Cyanocobalamin CYANOCOBALAMIN 4.5 ug
FOLIC ACID FOLIC ACID 1 mg
FERROUS FUMARATE FERROUS CATION 27 mg
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS 50 mg
NIACINAMIDE 13.5 mg
PYRIDOXINE HYDROCHLORIDE PYRIDOXINE 1.05 mg
RIBOFLAVIN RIBOFLAVIN 1.2 mg
THIAMINE MONONITRATE THIAMINE ION 1.05 mg
VITAMIN A ACETATE 2500 [iU]

Inactive Ingredients

Ingredient Name Strength
cellulose, microcrystalline
CROSCARMELLOSE SODIUM
ANHYDROUS CITRIC ACID
talc
MAGNESIUM STEARATE

Product Characteristics

Color Size Shape
BROWN (Light brown to brown-speckled) 18 mm OVAL

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
2012-12-07


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