PREPLUS- vitamin a acetate, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium, ferrous fumarate, zinc oxide, and cupric oxide tablet

Preplus by

Drug Labeling and Warnings

Preplus by is a Other medication manufactured, distributed, or labeled by Virtus Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HEALTH CLAIM

Supplement Facts
Serving Size: 1 Tablet
	Amount Per Serving	%Daily Value for Pregnant and Lactating Women
Vitamin A (as Acetate and Beta Carotene)	4000 IU	50%
Vitamin C (Ascorbic Acid)	120 mg	200%
Vitamin D (Vitamin D3 as cholecalciferol)	400 IU	100%
Vitamin E (dl-Alpha Tocopheryl Acetate)	22 IU	73%
Thiamine (Vitamin B1 from Thiamine Mononitrate)	1.84 mg	108%
Riboflavin (Vitamin B2)	3 mg	150%
Niacin (Niacinamide)	20 mg	100%
Vitamin B6 (as Pyridoxine HCl)	10 mg	400%
Folic Acid	1 mg	125%
Vitamin B12 (Cyanocobalamin)	12 mcg	150%
Calcium	200 mg	15%
Iron (Ferrous Fumarate)	27 mg	150%
Zinc (Zinc Oxide)	25 mg	167%
Copper (Cupric Oxide)	2 mg	100%

Other Ingredients: Microcrystalline Cellulose Kosher, Stearic Acid Kosher, Croscarmellose Sodium Kosher, Magnesium Stearate Kosher, Silicon Dioxide Kosher, FD&C Red #40 (Lakes), FD&C Blue #2 Aluminum Lake, and FD&C Yellow Lake #5.

Contains FD&C Red #40 (Lakes), FD&C Blue #2 Aluminum Lake, and FD&C Yellow Lake #5.

DESCRIPTION

PrePLUS (PNV-Ca with 27 mg Fe; 1 mg FA) Tablet is an orally administered prenatal/postnatal prescription folic acid-containing dietary supplement and should be administered under the supervision of a licensed medical practitioner.

DOSAGE AND ADMINISTRATION

Before, during and/or after pregnancy, one tablet daily, with a meal, or as directed by a licensed healthcare practitioner regardless of lactation status.

WARNINGS

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

CAUTION

High levels of folic acid may, especially in older adults, hide signs of Vitamin B-12 deficiency (such as pernicious anemia), a condition that can cause nerve damage.

SAFE HANDLING WARNING

Store at 15° – 30°C (59° – 86°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight, light-resistant container. Notice: Contact with moisture may produce surface discoloration or erosion.

HEALTH CLAIM

Call your licensed medical practitioner about side effects. You may report side effects by calling Virtus at 1-888-848-3593 or 1-800-FDA-1088.

HOW SUPPLIED

Supplied as beige tablet, imprinted "V258" dispensed in bottles of 500 tablets.

HEALTH CLAIM

Manufactured for:
Virtus Pharmaceuticals, LLC
Tampa, Florida 33619
1-888-848-3593

Rev. 03/15

PRINCIPAL DISPLAY PANEL - 500 Tablet Bottle Label

VIRTUS
PHARMACEUTICALS

69543-258-50

PrePLUS tablet
(PNV-Ca with 27 mg Fe;
1 mg FA)

PRENATAL / POSTNATAL

Prescription Folic Acid-Containing
Dietary Supplement

RX
500 Tablets

Made in USA

INGREDIENTS AND APPEARANCE

PREPLUS 
vitamin a acetate, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium, ferrous fumarate, zinc oxide, and cupric oxide tablet

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:69543-258
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
VITAMIN A ACETATE (UNII: 3LE3D9D6OY) (VITAMIN A - UNII:81G40H8B0T)	VITAMIN A	4000 [iU]
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	120 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	400 [iU]
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01)	.ALPHA.-TOCOPHEROL, DL-	22 [iU]
THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J)	THIAMINE	1.84 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR)	RIBOFLAVIN	3 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	20 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE HYDROCHLORIDE	10 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	12 ug
CALCIUM (UNII: SY7Q814VUP) (CALCIUM - UNII:SY7Q814VUP)	CALCIUM	200 mg
FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	27 mg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	25 mg
CUPRIC OXIDE (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L)	CUPRIC CATION	2 mg

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STEARIC ACID (UNII: 4ELV7Z65AP)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FD&C RED NO. 40 (UNII: WZB9127XOA)
ALUMINUM OXIDE (UNII: LMI26O6933)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:69543-258-10	100 in 1 BOTTLE
2	NHRIC:69543-258-50	500 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
DIETARY SUPPLEMENT		07/17/2015

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
scoring	1
shape
size (solid drugs)	19 mm
imprint

Labeler - Virtus Pharmaceuticals (079659493)