PrePLUS Tablet
Product Overview
Brand: Virtus Pharmaceuticals
Barcode: 3 69543 25850 8
Net Contents: 500 Tablet(s)
Serving Size (Overview): 1 Tablet(s)
Product Type: Multi-Vitamin and Mineral (MVM) [A1315]
Form: Tablet or Pill [E0155]
Date Entered: Sep 21, 2018
Market Status: On Market
Suggested Use (Overview): 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.
Product Self-Roles:
- No specific self-roles defined.
Dietary Supplement Facts
| Ingredient | Category | Amount Per Serving | Unit | % Daily Value | Target Group | Serving Size (Fact) |
|---|---|---|---|---|---|---|
| Vitamin A | vitamin | 4000 | IU | 50 | Pregnant and Lactating | 1 Tablet(s) |
| Vitamin C | vitamin | 120 | mg | 200 | Pregnant and Lactating | 1 Tablet(s) |
| Vitamin D | vitamin | 400 | IU | 100 | Pregnant and Lactating | 1 Tablet(s) |
| Vitamin E | vitamin | 22 | IU | 73 | Pregnant and Lactating | 1 Tablet(s) |
| Thiamine | vitamin | 1.84 | mg | 108 | Pregnant and Lactating | 1 Tablet(s) |
| Riboflavin | vitamin | 3 | mg | 150 | Pregnant and Lactating | 1 Tablet(s) |
| Niacin | vitamin | 20 | mg | 100 | Pregnant and Lactating | 1 Tablet(s) |
| Vitamin B6 | vitamin | 10 | mg | 400 | Pregnant and Lactating | 1 Tablet(s) |
| Folic Acid | vitamin | 1 | mg | 125 | Pregnant and Lactating | 1 Tablet(s) |
| Vitamin B12 | vitamin | 12 | mcg | 150 | Pregnant and Lactating | 1 Tablet(s) |
| Calcium | mineral | 200 | mg | 15 | Pregnant and Lactating | 1 Tablet(s) |
| Iron | mineral | 27 | mg | 150 | Pregnant and Lactating | 1 Tablet(s) |
| Zinc | mineral | 25 | mg | 167 | Pregnant and Lactating | 1 Tablet(s) |
| Copper | mineral | 2 | mg | 100 | Pregnant and Lactating | 1 Tablet(s) |
Other Ingredients
Microcrystalline Cellulose; Stearic Acid (C18:0); Croscarmellose Sodium; Magnesium Stearate; Silicon Dioxide (SiO2); FD&C Red #40 (Lakes); FD&C Blue #2 Aluminum Lake; FD&C Yellow Lake #5
Label Statements
Other
- 69543-258-50 RxMade in USA How supplied: Supplied as beige tablet imprinted 'V258 dispensed in bottles of 500 tablets.
Formulation
- (PNV-Ca with 27 mg Fe; 1 mg FA) Prescription Folic Acid-Containing Dietary Supplement Contains FD&C Red #40 (Lakes) FD&C Blue #2 Aluminum Lake and FD&C Yellow Lake #5.
Statement of Identity
- Prescription Folic Acid-Containing Dietary Supplement
Precautions
- 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. 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. 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.
Suggested Use
- 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.
Product Specific Information
- Store at 15(0); 30 (0)C (59(0); 86(0)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.
Product/Version Code
- Rev. 03/15
Associated Company Information & Roles
Virtus Pharmaceuticals LLC
Langhorne,
PA
19047
Roles for this Product:
- Distributor