Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED: Bottles of 30 softgels (75854-313-30). The listed product number is not a National Drug Code. Instead, Avion Pharmaceuticals has assigned a product code formatted according to standard industry practice to meet the formatting requirements of pharmacy and healthcare insurance computer systems.; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 75854-313-30 PRENATE ESSENTIAL ® Rx prenatal vitamin & DHA • Key vitamins, minerals, and DHA support nutrition GLUTEN FREE Rx Only Dietary Supplement 30 Softgels Essencial
- HOW SUPPLIED: Bottles of 30 softgels (75854-313-30). The listed product number is not a National Drug Code. Instead, Avion Pharmaceuticals has assigned a product code formatted according to standard industry practice to meet the formatting requirements of pharmacy and healthcare insurance computer systems.
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 75854-313-30 PRENATE ESSENTIAL ® Rx prenatal vitamin & DHA • Key vitamins, minerals, and DHA support nutrition GLUTEN FREE Rx Only Dietary Supplement 30 Softgels Essencial
Overview
PRENATE ESSENTIAL ® is a prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. Each softgel is green in color, opaque, and imprinted with "Prenate" on one side and blank on the other. PRENATE ESSENTIAL ® contains fish oil and soy. Prenate Essencial OTHER INGREDIENTS: Capsule gelatin (gelatin, sorbitol, glycerin, purified water, turmeric, and sodium copper chlorophyllin), soy lecithin, yellow beeswax and soybean oil.
Indications & Usage
INDICATIONS: PRENATE ESSENTIAL ® 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 ESSENTIAL ® can also be beneficial in improving the nutritional status of women prior to conception
Dosage & Administration
: Before, during and/or after pregnancy, one softgel daily or as directed by a physician.
Warnings & Precautions
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 known to have an inherited or acquired predisposition to bleeding.
Boxed 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.
Contraindications
: PRENATE ESSENTIAL ® is contraindicated in patients with a known hypersensitivity to any of the ingredients.
Adverse Reactions
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
Storage & Handling
STORAGE: Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature.]
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