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PreNatal Vitamins Plus DHA

Generic Name: multivitamins, DHA
Dosage Form: tablets, capsules

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.

PRENATAL VITAMINS
Supplement Facts
Serving Size: 1 Tablet
Servings Per Container: 30
Amount per serving % Daily Value
OTHER INGREDIENTS: Croscarmellose Sodium, Microcrystalline Cellulose, Talc and Magnesium Stearate.
Vitamin A (from Acetate and Beta Carotene) 4000 IU 50%
Vitamin C (Ascorbic Acid) 120 mg 200%
Vitamin D-3 (Cholecalciferol) 400 IU 100%
Vitamin E (dl-Alpha Tocopheryl Acetate) 22 mg 50%
Vitamin B-1 (from Thiamine Mononitrate) 1.84 mg 108%
Vitamin B-2 (Riboflavin) 3 mg 150%
Niacin (as Niacinamide) 20 mg 100%
Vitamin B-6 (from Pyridoxine HCl) 10 mg 400%
Folic Acid
Folate
1 mg
1700 mcg DFE
212%
Vitamin B-12 (Cyanocobalamin) 12 mcg 150%
Calcium (as Calcium Carbonate) 200 mg 15%
Iron (from Ferrous Fumarate) 27 mg 150%
Zinc (from Zinc Oxide) 25 mg 167%
Copper (from Cupric Oxide) 2 mg 100%
DHA* MINICAPS®
Supplement Facts
Serving Size: 1 MiniCap®
Servings Per Container: 30
Amount per serving % Daily Value
*Refers to Percent daily Value (%DV) based on a 2000 calorie diet.
*DHA as Ethyl Esters
†Daily Value not established.
OTHER INGREDIENTS: Fish Oil, Gelatin, Water, Glycerin, Orange Oil and Mixed Tocopherols.
Calories 5
  Calories from Fat 5
Total Fat 0.4 g 3%
  Saturated Fat 0 g 0%
  Polyunsaturated Fat <2 mg
  Monounsaturated Fat 3 IU
Cholesterol <2 mg 0%
Vitamin E 3 IU 10%
Total Omega-3 Fatty Acids 312 mg
DHA*(Docosahexaenoic Acid) 250 mg

PNV Prenatal Plus Multivitamin tablets and DHA* MiniCaps® are formulated to provide vitamin and mineral supplementation throughout pregnancy and during the postnatal period, for both lactating and non-lactating mothers, and are useful for improving nutritional status prior to conception.‡

In addition, the vital fatty acids in DHA* support brain, eye and nervous system development of your unborn child.‡

Safe easy-to-swallow MiniCaps® have no fishy odor or aftertaste.

PreNatal Vitamins Plus DHA Dosage and Administration

Before, during and after pregnancy, swallow 1 PNV Plus tablet and 1 DHA* MiniCap® SoftGel daily, or as directed by a physician.

TAMPER EVIDENT FEATURE

Do not use if inner-seal beneath cap is missing or broken.

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.

CAUTION

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

Other Information

To report a serious adverse event or obtain product information call 1-800-SCI-8711. 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 a child-resistant closure.

IF OVERDOSAGE IS SUSPECTED, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY 1-800-222-1222.

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 with the FDA.

†The manufacturer of this product requires that it be dispensed only under the order of a physician or licensed medical practitioner.

THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE.

LOT/EXP

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

REV 10/10/16
Manufactured in the USA

PRINCIPAL DISPLAY PANEL - Kit Carton

44946-2001-6

PNV Prenatal Health
PNV
Prenatal Vitamins

Prenatal Plus
MULTIVITAMIN
Tablets
+
DHA*
MINICAPS®

Dispense under a
physician's order

Provides vitamin and
mineral supplementation
throughout pregnancy and
postnatal period

Dietary Supplement

Mercury Free
Sugar & Gluten Free

UNIT DOSE PACK
30 TABLETS AND 30 MINICAPS®

PRENATAL PLUS MULTIVITAMIN PLUS DHA MINICAPS 
vitamin a, ascorbic acid, cholecalciferol, tocopherol, thiamine mononitrate, riboflavin, pyridoxine, folic acid, cyanocobalamin, calcium carbonate, ferrous fumarate, zinc oxide, cupric oxide, niacinamide, and fish oil kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:44946-2001
Packaging
# Item Code Package Description
1 NDC:44946-2001-6 1 KIT in 1 CARTON
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 BLISTER PACK 30 
Part 2 1 BLISTER PACK 30 
Part 1 of 2
PRENATAL PLUS MULTIVITAMIN 
vitamin a, ascorbic acid, cholecalciferol, tocopherol, thiamine mononitrate, riboflavin, pyridoxine, folic acid, cyanocobalamin, calcium carbonate, ferrous fumarate, zinc oxide, cupric oxide, and niacinamide tablet
Product Information
     
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VITAMIN A (VITAMIN A) VITAMIN A 4000 [iU]
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 120 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU]
TOCOPHEROL (TOCOPHEROL) TOCOPHEROL 22 mg
THIAMINE MONONITRATE (THIAMINE ION) THIAMINE 1.84 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 3 mg
PYRIDOXINE (PYRIDOXINE) PYRIDOXINE 10 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 12 ug
CALCIUM CARBONATE (CALCIUM CATION) CALCIUM CARBONATE 200 mg
FERROUS FUMARATE (FERROUS CATION) FERROUS CATION 27 mg
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 25 mg
CUPRIC OXIDE (CUPRIC CATION) CUPRIC CATION 2 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 20 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE  
MICROCRYSTALLINE CELLULOSE  
TALC  
MAGNESIUM STEARATE  
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 18mm
Flavor Imprint Code SCI7
Contains         
Packaging
# Item Code Package Description
1 30 TABLET in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 11/15/2016
Part 2 of 2
DHA MINICAPS 
fish oil capsule
Product Information
     
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FISH OIL (FISH OIL) FISH OIL 312 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN, UNSPECIFIED  
WATER  
GLYCERIN  
ORANGE OIL  
TOCOPHEROL  
Product Characteristics
Color YELLOW (Clear) Score no score
Shape OVAL Size 13mm
Flavor ORANGE Imprint Code
Contains         
Packaging
# Item Code Package Description
1 30 CAPSULE in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 11/15/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 11/15/2016
Labeler - Sancilio & Company, Inc. (176681257)
Revised: 11/2016
 
Sancilio & Company, Inc.



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