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PNV Prenatal plus Multivitamin

Package insert / prescribing information
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
Drug classes: Iron products, Vitamin and mineral combinations

Medically reviewed by Drugs.com. Last updated on May 23, 2022.

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Supplement Facts
Serving Size: 1 Tablet
Servings Per Container: 100
Amount per serving % Daily Value
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 1 mg 125%
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%

OTHER INGREDIENTS: Croscarmellose Sodium, Microcrystalline Cellulose, Talc, Magnesium Stearate.

PNV Prenatal Plus Multivitamin tablets 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.‡

DIRECTIONS

One tablet daily with a meal, 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 1-888-750-5290. 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.

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.

Manufactured for:
Agile RX LLC
Boynton Beach, FL 33437
(888) 750-5290

Made in the USA

LOT/EXP
REV 05/02/19

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

44946-1045-1

PNV Prenatal Health
PNV
Prenatal Vitamins

Prenatal Plus
MULTIVITAMIN
Tablets

Dispense under a
physician's order

Provides vitamin and
mineral supplementation
throughout pregnancy and
postnatal period

Dietary Supplement

Sugar & Gluten Free

100
TABLETS

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 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
MICROCRYSTALLINE CELLULOSE
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
Dietary Supplement 04/01/2013
Labeler - Agile RX (116742427)
Agile RX