Prenate Elite
Product Overview
Brand: Avion Pharmaceuticals
Net Contents: 30 Tablet(s)
Serving Size (Overview): 1 Tablet(s)
Product Type: Multi-Vitamin and Mineral (MVM) [A1315]
Form: Tablet or Pill [E0155]
Date Entered: Jun 16, 2022
Market Status: On Market
Suggested Use (Overview): Dosage and administration: Before; during and/or after pregnancy; one tablet daily or as directed by a physician.
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 | 780 | IU | 90 | Adults and children 4 or more years of age | 1 Tablet(s) |
| Vitamin A | vitamin | 780 | IU | 90 | Pregnant and Lactating | 1 Tablet(s) |
| Vitamin C | vitamin | 75 | mg | 125 | Adults and children 4 or more years of age | 1 Tablet(s) |
| Vitamin C | vitamin | 75 | mg | 125 | Pregnant and Lactating | 1 Tablet(s) |
| Vitamin D3 | vitamin | 15 | mcg | 75 | Adults and children 4 or more years of age | 1 Tablet(s) |
| Vitamin D3 | vitamin | 15 | mcg | 75 | Pregnant and Lactating | 1 Tablet(s) |
| Vitamin E | vitamin | 18 | mg | 120 | Adults and children 4 or more years of age | 1 Tablet(s) |
| Vitamin E | vitamin | 18 | mg | 120 | Pregnant and Lactating | 1 Tablet(s) |
| Thiamine | vitamin | 3 | mg | 200 | Adults and children 4 or more years of age | 1 Tablet(s) |
| Thiamine | vitamin | 3 | mg | 180 | Pregnant and Lactating | 1 Tablet(s) |
| Riboflavin | vitamin | 3.5 | mg | 210 | Adults and children 4 or more years of age | 1 Tablet(s) |
| Riboflavin | vitamin | 3.5 | mg | 175 | Pregnant and Lactating | 1 Tablet(s) |
| Niacinamide | vitamin | 21 | mg | 105 | Adults and children 4 or more years of age | 1 Tablet(s) |
| Niacinamide | vitamin | 21 | mg | 105 | Pregnant and Lactating | 1 Tablet(s) |
| Vitamin B6 | vitamin | 21 | mg | 1050 | Adults and children 4 or more years of age | 1 Tablet(s) |
| Vitamin B6 | vitamin | 21 | mg | 840 | Pregnant and Lactating | 1 Tablet(s) |
| Folate | vitamin | 1700 | mcg | 430 | Adults and children 4 or more years of age | 1 Tablet(s) |
| Folate | vitamin | 1700 | mcg | 280 | Pregnant and Lactating | 1 Tablet(s) |
| (6S)-N5-Methyltetrahydrofolic Acid Calcium Salt | vitamin | 1.1 | mg | N/A | N/A | 1 Tablet(s) |
| Folic Acid | vitamin | 400 | mcg | N/A | N/A | 1 Tablet(s) |
| Calcium | mineral | 155 | mg | 20 | Adults and children 4 or more years of age | 1 Tablet(s) |
| Calcium | mineral | 155 | mg | 10 | Pregnant and Lactating | 1 Tablet(s) |
| Iron | mineral | 20 | mg | 110 | Adults and children 4 or more years of age | 1 Tablet(s) |
| Iron | mineral | 20 | mg | 110 | Pregnant and Lactating | 1 Tablet(s) |
| Vitamin B12 | vitamin | 13 | mcg | 220 | Adults and children 4 or more years of age | 1 Tablet(s) |
| Vitamin B12 | vitamin | 13 | mcg | 160 | Pregnant and Lactating | 1 Tablet(s) |
| Biotin | vitamin | 330 | mcg | 110 | Adults and children 4 or more years of age | 1 Tablet(s) |
| Biotin | vitamin | 330 | mcg | 110 | Pregnant and Lactating | 1 Tablet(s) |
| Iodine | mineral | 150 | mcg | 100 | Adults and children 4 or more years of age | 1 Tablet(s) |
| Iodine | mineral | 150 | mcg | 100 | Pregnant and Lactating | 1 Tablet(s) |
| Magnesium | mineral | 25 | mg | 10 | Adults and children 4 or more years of age | 1 Tablet(s) |
| Magnesium | mineral | 25 | mg | 10 | Pregnant and Lactating | 1 Tablet(s) |
| Zinc | mineral | 15 | mg | 100 | Adults and children 4 or more years of age | 1 Tablet(s) |
| Zinc | mineral | 15 | mg | 100 | Pregnant and Lactating | 1 Tablet(s) |
| Copper | mineral | 1.5 | mg | 75 | Adults and children 4 or more years of age | 1 Tablet(s) |
| Copper | mineral | 1.5 | mg | 75 | Pregnant and Lactating | 1 Tablet(s) |
Other Ingredients
Croscarmellose Sodium; Magnesium Stearate; Microcrystalline Cellulose; Silicon Dioxide (SiO2); Stearic Acid (C18:0); Film Coating (Hydropropyl Methylcellulose; Titanium Dioxide; Triacetin)
Label Statements
Formulation
- Rx onlyDescription: Prenate Elite is a white oval oiland water-soluble multivitamin/multimineral film-coated tablet debossed with 'PN' on one side and blank on the other. Contains no ingredient made from gluten-containing grain (wheat barley or rye). Indications: Prenate Elite is a multivitamin/multimineral dietary supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers.
Precautions
- Contraindications: Prenate Elite is contraindicated in patients with a known hypersensitivity to any of the ingredients. Precautions: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress. 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. Adverse reactions: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
Suggested Use
- Dosage and administration: Before during and/or after pregnancy one tablet daily or as directed by a physician.
Other
- How supplied: Bottles of 30 tablets (75854-314-30).The listed product number is not a National Drug Code but has instead merely been formatted to comply with standard industry practice for pharmacy and insurance computer systems.
Product Specific Information
- Store at 20 degrees; 25 degrees C (68 degrees; 77 degrees F); excursions permitted to 15 degrees; 30 degrees C (59 degrees; 86 degrees F) [See USP Controlled Room Temperature.]
Statement of Identity
- 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.
Branding Statement(s)
- Formical is a registered trademark of Nephro-Tech 1 LLC covered by one or more claims of U.S. patent no. 6528542.Sumalate is a registered trademark of Albion Laboratories Inc. covered by one or more claims of U.S. patent nos. 5516925 6716814 8007846 and 8425956.
Associated Company Information & Roles
Avion Pharmaceuticals LLC
No address details available for this company.
Roles for this Product:
- Distributor