The following Structured Product Label (SPL) was submitted to the FDA by Deremetrx Llc for the product Pre-tabs Dha (NDC 48948-406). 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: Pre-Tabs DHA combination tablet-capsule for oral administration is a light blue capsule-shaped film coated tablet with a pleasant sweet flavor with WC001 imprinted on one side of the tablet and a light amber soft gel capsule omega-3 fatty acid containing both DHA and EPA.
Indications and Usage: Pre-Tabs 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. Pre-Tabs 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. Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.
Warnings: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where B12 is deficient.
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: Pre-Tabs DHA - One tablet and one soft gel capsule daily or as directed by a physician.
How Supplied: Pre-Tabs DHA tablets for oral administration are supplied as six child-resistant blister cards containing 5 tablets and 5 softgel capsules each (NDC# 48648-406-30).
Pre-Tabs DHA
Prenatal Multi-vitamin/Mineral Supplement
Gluten Free
NDC 48948-406-30 (30 count)
6 blister cards
each containing 5 tablets and 5 capsules
877-774-4949
Pretabs Dha Carton (Pretabs.4web)
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