The following Structured Product Label (SPL) was submitted to the FDA by Womens Choice Pharmaceuticals Llc for the product Nestabs Dha (NDC 50967-317). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding description, indications & usage, contraindications, warnings, boxed warning, precautions, adverse reactions, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Descripton: Nestabs DHA combination tablet-capsule for oral administration is a light pink capsule-shaped film coated tablet with a pleasant sweet flavor with WCOO1 imprinted on one side of the tablet and a enteric coated light amber soft gel capsule omega-3 fatty acid containing both DHA and EPA.
Indications and Usage: Nestabs DHA is indicated to provide vitamin/mineral and omega-3 fatty acid supplementation to women throughout pregnancy, during the postnatal for both lactating and nonlactating mothers. Nestabs DHA is also beneficial in improving the nutritional status of women prior to conception.
Contraindications: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients .
Warnings: Ingestion of more than 3 grams of omega-fatty acids per day has been shown to have potential antithrombotic effects, including increased bleeding time and INR. Administration of omega-3 fatty acids should be avoided in patients on anticoagulants and in those known to have an inherited or acquired bleeding diathesis.
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.
Precautions: Folic acid in doses above 0.1mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. This product contains formate, which if consumed above the recommended level, could cause visual impairment and other health effects. Do not take more than the recommended amount. If you are pregnant, nursing, or taking any medications consult your doctor before use. Discontinue use and consult your doctor if any adverse reactions occur. Not intended for use by persons under the age of 18.
Adverse Reactions: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
Dosage and Administration: Nestabs DHA - One tablet and one soft gel capsule daily or as directed by a physician.
How Supplied: Nestabs DHA tablets for oral administration are supplied as six child-resistant blister cards containing 5 tablets and 5 softgel capsules each (NDC# 50967-317-30).
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