{"adverse_reactions":["ADVERSE REACTIONS Allergic sensitization has been reported following both oral and parenteral administration of folic acid."],"boxed_warning":["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":["CONTRAINDICATIONS This product is contraindicated in patients with a known hypersensitivity to any of the ingredients."],"description":["DESCRIPTION Infanate DHA capsules are supplied as oblong, red, soft gelatin capsules with “334” imprinted in white. EACH CAPSULE CONTAINS: Docosahexaenoic Acid (DHA) 250 mg Eicosapentaenoic Acid (EPA) not more than 0.625 mg Calcium (tricalcium phosphate) 102 mg Iron (ferrous fumarate) 28 mg Vitamin C (ascorbic acid) 30 mg Vitamin B 6 (pyridoxine HCl) 25 mg Vitamin E (D-alpha tocopherol) 30 IU Folic Acid 1 mg DHA is an omega-3 fatty acid and the DHA in Infanate DHA is derived from the oils of microalgae. OTHER INGREDIENTS: yellow beeswax, soybean oil, lecithin oil, gelatin, glycerin, purified water, FD&C Red #40, caramel powder and titanium dioxide. Sugar, lactose, yeast and gluten free."],"description_table":["
EACH CAPSULE CONTAINS:
Docosahexaenoic Acid (DHA) 250 mg
Eicosapentaenoic Acid (EPA) not more than 0.625 mg
Calcium (tricalcium phosphate) 102 mg
Iron (ferrous fumarate) 28 mg
Vitamin C (ascorbic acid) 30 mg
Vitamin B6 (pyridoxine HCl) 25 mg
Vitamin E (D-alpha tocopherol) 30 IU
Folic Acid 1 mg
"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION One capsule daily, or as directed by a physician."],"effective_time":"20180515","how_supplied":["HOW SUPPLIED Infanate DHA is supplied in child-resistant bottles of 30 capsules (NDC# 42192-334-30). Store at 15° - 30°C (59° - 86°F) [See USP]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. Please note: this is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. No representation is made as to generic status or bioequivalency. Each person recommending a prescription substitution using this product shall make such recommendations based on each such person’s professional opinion and knowledge, upon evaluating the active ingredients, excipients, inactive ingredients and chemical information provided herein. MANUFACTURED FOR: Acella Pharmaceuticals, LLC Alpharetta, GA 30009 1-800-541-4802 Rev. 1010v2"],"id":"233e80c5-79ba-42ff-983b-d9167360fe68","indications_and_usage":["INDICATIONS Infanate DHA is indicated to provide vitamin/mineral and omega-3 fatty acid supplementation to women throughout pregnancy, during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. Infanate DHA may be beneficial in improving the nutritional status of women prior to conception."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 30 Capsules NDC 42192-334-30 Infanate DHA R x Prenatal Vitamin and Plant-Based DHA R x Only 30 Capsules Acella PHARMACEUTICALS, LLC Infanate DHA"],"precautions":["PRECAUTIONS Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress. Pediatric Use: Safety and effectiveness in pediatric patients have not been established. Geriatric Use: Clinical studies on this product have not been performed to determine whether elderly subjects respond differently from younger subjects."],"set_id":"dcc341a3-326d-4694-9c57-adb76a8da2fa","spl_product_data_elements":["Infanate DHA DOCONEXENT, ICOSAPENT, TRICALCIUM PHOSPHATE, FERROUS FUMARATE, ASCORBIC ACID, PYRIDOXINE HYDROCHLORIDE, .ALPHA.-TOCOPHEROL ACETATE, DL-, FOLIC ACID YELLOW WAX SOYBEAN OIL LECITHIN, SOYBEAN GELATIN, UNSPECIFIED GLYCERIN WATER FD&C RED NO. 40 CARAMEL TITANIUM DIOXIDE SUCROSE LACTOSE, UNSPECIFIED FORM YEAST, UNSPECIFIED WHEAT GLUTEN DOCONEXENT DOCONEXENT ICOSAPENT ICOSAPENT TRICALCIUM PHOSPHATE CALCIUM CATION FERROUS FUMARATE FERROUS CATION ASCORBIC ACID ASCORBIC ACID PYRIDOXINE HYDROCHLORIDE PYRIDOXINE .ALPHA.-TOCOPHEROL ACETATE, DL- .ALPHA.-TOCOPHEROL, DL- FOLIC ACID FOLIC ACID 334"],"spl_unclassified_section":["Rx Only"],"version":"1","warnings":["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."]}