FDA Label for Pnv Prenatal Vitamin Plus Vitamin A
View Indications, Usage & Precautions
Pnv Prenatal Vitamin Plus Vitamin A Product Label
The following document was submitted to the FDA by the labeler of this product Sancilio & Company Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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 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.
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
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