Pnv Prenatal Vitamin
FDA Label NDC 44946-1046

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sancilio & Company Inc for the product Pnv Prenatal Vitamin (NDC 44946-1046). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, description, other ingredients, directions, caution, warning, adverse reactions, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

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.

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

Description

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 Acid1 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.

Storage And Handling

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.

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

Principal Display Panel (400 Tablet Bottle Label)

Principal Display Panel (400 Tablet Bottle Label)

* Please review the disclaimer below.