PrePLUS tablet

Manufacturer
A-S Medication Solutions
Effective date
2021-03-01
Label type
DIETARY SUPPLEMENT
Version
9
Source
full-release
Hydrated at
2026-06-01 02:49:54

Label at a glance#

ProductPreplus
Active ingredientVITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM, FERROUS FUMARATE, ZINC OXIDE, CUPRIC OXIDE
Label structure10 sections

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.

Label contents#

Full prescribing information#

HEALTH CLAIM SECTION

Supplement Facts
Serving Size: 1 Tablet
Amount Per Serving%Daily Value
for Pregnant
and Lactating
Women
Vitamin A (as Acetate and Beta Carotene)4000 IU50%
Vitamin C (Ascorbic Acid)120 mg200%
Vitamin D (Vitamin D3 as cholecalciferol)400 IU100%
Vitamin E (dl-Alpha Tocopheryl Acetate)22 IU73%
Thiamine (Vitamin B1 from Thiamine Mononitrate)1.84 mg108%
Riboflavin (Vitamin B2)3 mg150%
Niacin (Niacinamide)20 mg100%
Vitamin B6 (as Pyridoxine HCl)10 mg400%
Folic Acid1 mg125%
Vitamin B12 (Cyanocobalamin)12 mcg150%
Calcium200 mg15%
Iron (Ferrous Fumarate)27 mg150%
Zinc (Zinc Oxide)25 mg167%
Copper (Cupric Oxide)2 mg100%

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

STATEMENT OF IDENTITY SECTION

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

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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

PRECAUTIONS SECTION

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 SECTION

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 SECTION

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

HEALTH CLAIM SECTION

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

HEALTH CLAIM SECTION

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

Rev. 03/15

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASCORBIC ACID Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CALCIUM Pharmacologic Class Indexing3Indexing - Pharmacologic Class20230427
CHOLECALCIFEROL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CYANOCOBALAMIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PYRIDOXINE Pharmacologic Class Indexing1Indexing - Pharmacologic Class20170310
VITAMIN A Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
cf050ccd-1144-f76a-e00d-e5698d8597d4Product name620250625
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3544-0Preplus100 in 1 BOTTLETABLET1009
50090-3544-1Preplus30 in 1 BOTTLE, PLASTICTABLET309

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3544PREPLUS (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 [A-S MEDICATION SOLUTIONS]92 package rows20210303_10f86ac6-4d53-461a-88c8-3bc99fe2346c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69543-258-10EA - Each69543-2585a150896-d2e1-45c1-9e40-37b263613cef12015-10-02
69543-258-50EA - Each69543-258bc8c819a-faba-43a2-aa5f-84aedeb8d7cf12015-10-02

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50090-354450090-3544-1, 50090-3544-0
69543-258

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.