Prenate DHA
Product Overview
Brand: Avion Pharmaceuticals
Net Contents: N/A
Serving Size (Overview): 1 Softgel(s)
Product Type: Other Combinations [A1325]
Form: Softgel Capsule [E0161]
Date Entered: Nov 25, 2013
Market Status: On Market
Suggested Use (Overview): DOSAGE AND ADMINISTRATION: Before; during and/or after pregnancy; one softgel daily or as directed by a physician.
Product Self-Roles:
- Acts in Other Role
Dietary Supplement Facts
| Ingredient | Category | Amount Per Serving | Unit | % Daily Value | Target Group | Serving Size (Fact) |
|---|---|---|---|---|---|---|
| Vitamin C | vitamin | 90 | mg | 150 | Adults and children 4 or more years of age | 1 Softgel(s) |
| Vitamin C | vitamin | 90 | mg | 150 | Pregnant and Lactating | 1 Softgel(s) |
| Vitamin D3 | vitamin | 220 | IU | 55 | Adults and children 4 or more years of age | 1 Softgel(s) |
| Vitamin D3 | vitamin | 220 | IU | 55 | Pregnant and Lactating | 1 Softgel(s) |
| Vitamin E | vitamin | 10 | IU | 33 | Adults and children 4 or more years of age | 1 Softgel(s) |
| Vitamin E | vitamin | 10 | IU | 33 | Pregnant and Lactating | 1 Softgel(s) |
| Vitamin B6 | vitamin | 26 | mg | 1300 | Adults and children 4 or more years of age | 1 Softgel(s) |
| Vitamin B6 | vitamin | 26 | mg | 1040 | Pregnant and Lactating | 1 Softgel(s) |
| Folate | vitamin | 1 | mg | 250 | Adults and children 4 or more years of age | 1 Softgel(s) |
| Folate | vitamin | 1 | mg | 125 | Pregnant and Lactating | 1 Softgel(s) |
| Quatrefolic | non-nutrient/non-botanical | 1.1 | mg | N/A | N/A | 1 Softgel(s) |
| Folic Acid | vitamin | 400 | mcg | N/A | N/A | 1 Softgel(s) |
| Vitamin B12 | vitamin | 13 | mcg | 217 | Adults and children 4 or more years of age | 1 Softgel(s) |
| Vitamin B12 | vitamin | 13 | mcg | 163 | Pregnant and Lactating | 1 Softgel(s) |
| Calcium | mineral | 145 | mg | 15 | Adults and children 4 or more years of age | 1 Softgel(s) |
| Calcium | mineral | 145 | mg | 11 | Pregnant and Lactating | 1 Softgel(s) |
| Iron | mineral | 28 | mg | 156 | Adults and children 4 or more years of age | 1 Softgel(s) |
| Iron | mineral | 28 | mg | 156 | Pregnant and Lactating | 1 Softgel(s) |
| Magnesium | mineral | 50 | mg | 13 | Adults and children 4 or more years of age | 1 Softgel(s) |
| Magnesium | mineral | 50 | mg | 11 | Pregnant and Lactating | 1 Softgel(s) |
| Docosahexaenoic Acid | fatty acid | 300 | mg | N/A | Adults and children 4 or more years of age | 1 Softgel(s) |
| Docosahexaenoic Acid | fatty acid | 300 | mg | N/A | Pregnant and Lactating | 1 Softgel(s) |
Other Ingredients
Bee's Wax; hydrogenated Vegetable Oil; Soy Lecithin; Gelatin; Glycerin; purified Water; Titanium Dioxide; FD&C Blue #1; FD&C Red #3
Label Statements
Formulation
- Rx prenatal vitamin & DHA With Quatrefolic(R) INDICATIONS: PRENATE DHA(R) is a multivitamin/multimineral fatty acid 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 DHA(R) can also be beneficial in improving the nutritional status of women prior to conception. PRENATE DHA(R) contains fish oil and soy.
Other
- Rx Only HOW SUPPLIED: Unit-dose packs of 30 softgels. (75854-302-30).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.
Branding Statement(s)
- DESCRIPTION: PRENATE DHA(R) is a prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. Each softgel is blue in color opaque and imprinted with 'DHA' 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 # 7947662CAS# 1181972-37-1 PRENATE ELITE(R) is a registered trademark of Acella Pharmaceuticals LLC.Under license from Acella Pharmaceuticals LLC.All rights reserved.
Precautions
- CONTRAINDICATIONS: PRENATE DHA(R) is contraindicated in patients with a known hypersensitivity to any of the ingredients. WARNING: Ingestion of more than 3 grams of omega-3 fatty acids (such as DHA) per day has been shown to have potential antithrombotic effects including an increased bleeding time and International Normalized Ratio (INR). Administration of omega-3 fatty acids should be avoided in patients taking anticoagulants and in those know to have an inherited or acquired predisposition to bleeding. PRECAUTIONS: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloglastic 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. 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. ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid. Administration of omega-3 fatty acids should be avoided in patients taking anticoagulants and in those know to have an inherited or acquired predisposition to bleeding. PRENATE DHA(R) contains fish oil and soy.
Suggested Use
- DOSAGE AND ADMINISTRATION: Before during and/or after pregnancy one softgel daily or as directed by a physician.
Product/Version Code
- Rev. 021412
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.]
Associated Company Information & Roles
Avion Pharmaceuticals LLC
No address details available for this company.
Roles for this Product:
- Distributor