The following Structured Product Label (SPL) was submitted to the FDA by Womens Choice Pharmaceuticals Llc for the product Nestabs (NDC 50967-219). 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 boxed warning, description, indications & usage, contraindications, warnings, precautions, dosage & administration, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Description: Nestabs tablets for oral administration is a light pink capsule shaped film coated tablet with a pleasant sweet flavor with WC001 imprinted on one side of the tablet.
Indications and Usage: Nestabs is indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers. Nestabs 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: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.
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.
Dosage and Administration: One tablet daily or as directed by a physician.
Nestabs Bottle Label (Nestabsbottlelabel)
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