Supplement Label Index / Avion Pharmaceuticals

Prenate DHA

Avion Pharmaceuticals · Softgel Capsule · On market

Matched compounds

How these doses compare

• Calcium: 145 elemental mg per serving — higher than 58% of 18,473 on-market products declaring it (market median 112 elemental mg).
• Folate (Vitamin B9): 2,500 mcg DFE per serving — higher than 96% of 5,690 on-market products declaring it (market median 666 mcg DFE).
• Iron: 28 elemental mg per serving — higher than 92% of 7,061 on-market products declaring it (market median 5 elemental mg).
• Magnesium: 50 elemental mg per serving — higher than 33% of 14,120 on-market products declaring it (market median 80 elemental mg).
• Omega-3 Fatty Acids (EPA + DHA): 300 mg per serving — higher than 30% of 4,268 on-market products declaring it (market median 501 mg).
• Vitamin B12 (Cobalamin): 13 mcg per serving — higher than 36% of 14,041 on-market products declaring it (market median 35 mcg).
• Vitamin B6 (Pyridoxine): 26 mg per serving — higher than 81% of 15,068 on-market products declaring it (market median 6 mg).
• Vitamin C: 90 mg per serving — higher than 37% of 18,522 on-market products declaring it (market median 120 mg).
• Vitamin D: 5.5 mcg per serving — higher than 17% of 13,822 on-market products declaring it (market median 17.5 mcg).

Per serving as declared; serving sizes and daily directions differ between products.

Excipients

• FD&C Blue #1
• FD&C Red #3
• Gelatin
• Glycerin
• Soy Lecithin
• Titanium Dioxide — Food Additive Index
• Water

Label statements

• other: Rx prenatal vitamin & DHA
• other: With Quatrefolic(R)
• claim: Rx Only
• other: 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.
• other: 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.
• warning: CONTRAINDICATIONS: PRENATE DHA(R) is contraindicated in patients with a known hypersensitivity to any of the ingredients.
• warning: 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.
• warning: 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: 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.
• warning: ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
• other: DOSAGE AND ADMINISTRATION: Before, during and/or after pregnancy, one softgel daily or as directed by a physician.
• claim: 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.
• other: Quatrefolic(R) is a registered trademark of Gnosis, SpA. Covered by one or more claims of U.S. Patent # 7,947,662 CAS# 1181972-37-1
• other: PRENATE ELITE(R) is a registered trademark of Acella Pharmaceuticals, LLC. Under license from Acella Pharmaceuticals, LLC. All rights reserved.
• other: Rev. 021412
• warning: 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.
• other: 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.]
• other: PRENATE DHA(R) contains fish oil and soy.
• warning: PRENATE DHA(R) contains fish oil and soy.

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