Medication Guide App

PNV Prenatal plus Multivitamin

Generic Name: vitamin a acetate, .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, ferrous fumarate, zinc oxide and cupric oxide
Dosage Form: tablet

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

PNV Prenatal plus Multivitamin Tablets

Each PNV Tablet Contains: Amount Per Serving
Vitamin A (from Acetate and Beta Carotene) 4000 I.U.
Vitamin C (Ascorbic Acid) 120 mg
Vitamin D-3 (Cholecalciferol) 400 I.U.
Vitamin E (dl-Alpha Tocopheryl Acetate) 22 mg
Vitamin B-1 (from Thiamine Mononitrate) 1.84 mg
Vitamin B-2 (Riboflavin) 3 mg
Niacin (as Niacinamide) 20 mg
Vitamin B-6 (from Pyridoxine HCl) 10 mg
Folic Acid 1 mg
Vitamin B-12 (Cyanocobalamin) 12 mcg
MINERALS:
Calcium (as Calcium Carbonate) 200 mg
Iron (from Ferrous Fumarate) 27 mg
Zinc (from Zinc Oxide) 25 mg
Copper (from Cupric Oxide) 2 mg

Other Ingredients: Croscarmellose Sodium, Microcrystalline Cellulose, Talc, Magnesium Stearate.

Indications

To provide Vitamin and Mineral supplementation throughout pregnancy and during the postnatal period for both the lactating and non-lactating mother. It is also useful for improving nutritional status prior to conception.

Dosage

As a dietary adjunct before, during and after pregnancy, take one tablet daily with a meal, or as directed by a physician.

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.

Precautions

Folic Acid may mask the symptoms of hematological damage due to Vitamin B12 deficiency of pernicious anemia while the associated neurological damage progresses.

STORE AT CONTROLLED ROOM TEMPERATURE 15°-30°C (59°-86°F). AVOID EXCESS HEAT. Dispense in a well closed light-resistant container, with a child resistant cap.

This medical food product is formulated to be administered orally, under the supervision of a physician.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Manufactured by:
Sancilio & Company, Inc.
3874 Fiscal Court
Riviera Beach, FL 33404
(800)SCI-8711

REV: 04/11/13

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

44946-1045-1
Rx only

PNV Prenatal Health
PNV
Prenatal Vitamins

Prenatal Plus
MULTIVITAMIN
Tablets

Sugar & Gluten Free

SCI
Sancilio & Company, Inc

Developing good science into great medicine

100
TABLETS

DO NOT USE IF SAFETY SEAL UNDER CAP
IS BROKEN OR MISSING

PNV Prenatal plus Multivitamin 
vitamin a acetate, .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, ferrous fumarate, zinc oxide, and cupric oxide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:44946-1045
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VITAMIN A ACETATE (VITAMIN A) VITAMIN A 2000 [iU]
.BETA.-CAROTENE (.BETA.-CAROTENE) .BETA.-CAROTENE 2000 [iU]
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 120 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU]
.ALPHA.-TOCOPHEROL ACETATE, DL- (.ALPHA.-TOCOPHEROL, DL-) .ALPHA.-TOCOPHEROL, DL- 22 mg
THIAMINE MONONITRATE (THIAMINE ION) THIAMINE 1.84 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 3 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 20 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE 10 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 12 ug
CALCIUM CARBONATE (CALCIUM CATION) CALCIUM CATION 200 mg
FERROUS FUMARATE (FERROUS CATION) FERROUS CATION 27 mg
ZINC OXIDE (ZINC CATION) ZINC CATION 25 mg
CUPRIC OXIDE (CUPRIC CATION) CUPRIC CATION 2 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM  
CELLULOSE, MICROCRYSTALLINE  
TALC  
MAGNESIUM STEARATE  
Product Characteristics
Color YELLOW (Off-white speckled) Score no score
Shape OVAL Size 19mm
Flavor Imprint Code SCI7
Contains         
Packaging
# Item Code Package Description
1 NDC:44946-1045-1 100 TABLET in 1 BOTTLE, PLASTIC
2 NDC:44946-1045-4 30 TABLET in 1 BOTTLE, PLASTIC
3 NDC:44946-1045-9 500 TABLET in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 04/01/2013
Labeler - Sancilio & Company Inc (176681257)
Revised: 08/2013
 
Sancilio & Company Inc



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