Prenate Elite
Product Overview
Brand: Avion Pharmaceuticals
Net Contents: N/A
Serving Size (Overview): 1 Tablet(s)
Product Type: Other Combinations [A1325]
Form: Tablet or Pill [E0155]
Date Entered: Sep 25, 2013
Market Status: On Market
Suggested Use (Overview): DOSAGE AND ADMINISTRATION: 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 | 2600 | IU | 50 | Adults and children 4 or more years of age | 1 Tablet(s) |
| Vitamin A | vitamin | 2600 | IU | 33 | 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 | 450 | IU | 113 | Adults and children 4 or more years of age | 1 Tablet(s) |
| Vitamin D3 | vitamin | 450 | IU | 113 | Pregnant and Lactating | 1 Tablet(s) |
| Vitamin E | vitamin | 10 | IU | 33 | Adults and children 4 or more years of age | 1 Tablet(s) |
| Vitamin E | vitamin | 10 | IU | 33 | 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 | 176 | Pregnant and Lactating | 1 Tablet(s) |
| Riboflavin | vitamin | 3.5 | mg | 206 | Adults and children 4 or more years of age | 1 Tablet(s) |
| Riboflavin | vitamin | 3.5 | mg | 175 | Pregnant and Lactating | 1 Tablet(s) |
| Niacin | vitamin | 21 | mg | 105 | Adults and children 4 or more years of age | 1 Tablet(s) |
| Niacin | 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 | 1 | mg | 250 | Adults and children 4 or more years of age | 1 Tablet(s) |
| Folate | vitamin | 1 | mg | 125 | Pregnant and Lactating | 1 Tablet(s) |
| Quatrefolic | non-nutrient/non-botanical | 1.1 | mg | N/A | N/A | 1 Tablet(s) |
| Folic Acid | vitamin | 400 | mcg | N/A | N/A | 1 Tablet(s) |
| Vitamin B12 | vitamin | 13 | mcg | 217 | Adults and children 4 or more years of age | 1 Tablet(s) |
| Vitamin B12 | vitamin | 13 | mcg | 163 | 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) |
| Pantothenic Acid | vitamin | 6 | mg | 60 | Adults and children 4 or more years of age | 1 Tablet(s) |
| Pantothenic Acid | vitamin | 6 | mg | 60 | Pregnant and Lactating | 1 Tablet(s) |
| Calcium | mineral | 100 | mg | 10 | Adults and children 4 or more years of age | 1 Tablet(s) |
| Calcium | mineral | 100 | mg | 8 | Pregnant and Lactating | 1 Tablet(s) |
| Iron | mineral | 26 | mg | 144 | Adults and children 4 or more years of age | 1 Tablet(s) |
| Iron | mineral | 26 | mg | 144 | 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 | 6 | Adults and children 4 or more years of age | 1 Tablet(s) |
| Magnesium | mineral | 25 | mg | 6 | 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
Dicalcium Phosphate; Microcrystalline Cellulose; Stearic Acid (C18:0); aqueous coating; Croscarmellose Sodium; Silica; Magnesium Stearate; Titanium Dioxide
Label Statements
Formulation
- INDICATIONS: PRENATE ELITE(R) 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.PRENATE ELITE(R) can also be beneficial in improving the nutritional status of women prior to conception. PRENATAL VITAMINS-FILM COATED TABLETS With Quatrefolic(R)
Precautions
- CONTRAINDICATIONS: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. 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.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. 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 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress. ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
Suggested Use
- DOSAGE AND ADMINISTRATION: One tablet daily or as directed by a physician.
Branding Statement(s)
- PRENATE ELITE(R) is a registered trademark of Acella Pharmaceuticals LLC.Under license from Acella Pharmaceuticals LLC.All rights reserved. DESCRIPTION: PRENATE ELITE(R) is a white oval oiland water-soluble multivitamin/multimineral film-coated tablet debossed with 'PN' on one side and blank on the other. Quatrefolic(R) is a registered trademark of Gnosis SpA.Covered by one or more claims of U.S. Patent # 7947662
Other
- Rx Only HOW SUPPLIED: PRENATE ELITE(R) is supplied in child-resistant bottles of 90 tablets (75854-301-90).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(0); 25(0)C (68(0); 77(0)F); excursions permitted to 15(0) -30(0)C (59(0); 86(0)F) [See USP Controlled Room Temperature.]
Product/Version Code
- Rev. 022012
Associated Company Information & Roles
Avion Pharmaceuticals LLC
No address details available for this company.
Roles for this Product:
- Distributor