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Pre-Tabs DHA Prenatal Multi-vitamin/Mineral Supplement with DHA/EPA Package Insert

Status:
Prescription (Rx) Boxed warning Facts
Strength:
120 mg, 450 IU, 30 IU, 3 mg, 3 mg, 20 mg, 50 mg, 1 mg, 10 mcg, 155 mg, 45 mg, 32 mg, 100 mcg, 10 mg, 55 mg, 230 mg, 30 mg, 2 IU

Prescribing information (package insert) - Pre-Tabs DHA Prenatal Multi-vitamin/Mineral Supplement with DHA/EPA

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).

About this document

Source: FDA drug labeling via NLM DailyMed · View the label on DailyMed

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Drug information for Pre-Tabs DHA Prenatal Multi-vitamin/Mineral Supplement with DHA/EPA

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Boxed warning Yes – this drug has a boxed warning (also called a black box warning), the strongest warning of the FDA.
Drug class Blood Coagulation Factor, Copper Absorption Inhibitor, Phosphate Binder, Vitamin B12, Vitamin B6 Analog, Vitamin C, Vitamin D
Active ingredients Sodium ascorbate 120 mg, Cholecalciferol 450 IU, Tocophersolan 30 IU, Thiamine mononitrate 3 mg, Riboflavin 3 mg, Niacinamide 20 mg, Pyridoxine hydrochloride 50 mg, Folic acid 1 mg, Cyanocobalamin 10 mcg, Calcium formate 155 mg, Calcium carbonate 45 mg, Ferrous bisglycinate 32 mg, Potassium iodide 100 mcg, Zinc oxide 10 mg, Choline bitartrate 55 mg, Doconexent 230 mg, Icosapent 30 mg, Alpha-tocopherol, D- 2 IU
Dosage form Kit
Marketing status not in the current FDA NDC Directory
Company (applicant) DEREMETRX LLC
FDA approval UNAPPROVED DRUG OTHERUnapproved drug
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
120 mg, 450 IU, 30 IU, 3 mg, 3 mg, 20 mg, 50 mg, 1 mg, 10 mcg, 155 mg, 45 mg, 32 mg, 100 mcg, 10 mg, 55 mg, 230 mg, 30 mg, 2 IU – 1 in 1 blister pack / 6 in 1 carton NDC 48948-406-30

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.