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Pre-Tabs DHA

Generic Name: prenatal multi-vitamin/mineral
Dosage Form: tablet

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Pre-Tabs DHA Prenatal Multi-vitamin/Mineral Tablet

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

www.dermetrx.com

Pre-Tabs DHA  PRENATAL MULTI-VITAMIN/MINERAL SUPPLEMENT WITH DHA/EPA
sodium ascorbate, cholecalciferol, di-alpha-tocopheryl acetate, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hcl, folic acid, cyanocobalamin, calcium formate, calcium carbonate, ferrous (ii) bis-glycinate chelate, potassium iodide, zinc oxide, choline bitartrate, with doconexent and icosapent kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:48948-406
Packaging
# Item Code Package Description
1 NDC:48948-406-30 6 BLISTER PACK in 1 CARTON
1 1 KIT (KIT) in 1 BLISTER PACK
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 5 PACKAGE
Part 2 5 PACKAGE
Part 1 of 2
Pre-Tabs DHA  MULTI-VITAMIN/MINERAL SUPPLEMENT
sodium ascorbate, cholecalciferol, di-alpha-tocopheryl acetate, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hcl, folic acid, cyanocobalamin, calcium formate, calcium carbonate, polysaccharide iron complex, potassium iodide, zinc oxide, choline bitartrate tablet
Product Information
     
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM ASCORBATE (ASCORBIC ACID) SODIUM ASCORBATE 120 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 450 [iU]
TOCOPHERSOLAN (TOCOPHERSOLAN) TOCOPHERSOLAN 30 [iU]
THIAMINE MONONITRATE (THIAMINE ION) THIAMINE 3 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 3 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 20 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE 50 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 10 ug
CALCIUM FORMATE (CALCIUM CATION) CALCIUM CATION 155 mg
CALCIUM CARBONATE (CALCIUM CATION) CALCIUM CATION 45 mg
FERROUS BISGLYCINATE (FERROUS CATION) FERROUS CATION 32 mg
POTASSIUM IODIDE (IODIDE ION) IODIDE ION 100 ug
ZINC OXIDE (ZINC CATION) ZINC CATION 10 mg
CHOLINE BITARTRATE (CHOLINE) CHOLINE 55 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE  
POLYVINYL ALCOHOL  
POVIDONE  
TITANIUM DIOXIDE  
POLYETHYLENE GLYCOL 3350  
TALC  
MALTODEXTRIN  
FD&C BLUE NO. 1  
POLYSORBATE 80  
CARNAUBA WAX  
SACCHARIN SODIUM  
Product Characteristics
Color blue (LIGHT BLUE) Score 2 pieces
Shape OVAL Size 18mm
Flavor Imprint Code WC;001
Contains         
Packaging
# Item Code Package Description
1 1 TABLET in 1 PACKAGE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 06/15/2014
Part 2 of 2
NESTABS ABC OMEGA 3-DHA 
doconexent and icosapent supplement capsule, gelatin coated
Product Information
     
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOCONEXENT (DOCONEXENT) DOCONEXENT 230 mg
ICOSAPENT (ICOSAPENT) ICOSAPENT 30 mg
ALPHA-TOCOPHEROL, D- (.ALPHA.-TOCOPHEROL, D-) ALPHA-TOCOPHEROL, D- 2 [iU]
Inactive Ingredients
Ingredient Name Strength
GELATIN  
GLYCERIN  
WATER  
Product Characteristics
Color yellow Score no score
Shape capsule Size 6mm
Flavor Imprint Code
Contains         
Packaging
# Item Code Package Description
1 1 CAPSULE, GELATIN COATED in 1 PACKAGE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 06/15/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 06/15/2014
Labeler - DEREMETRX LLC (079203275)
Registrant - DERMETRX LLC (079203275)
Revised: 09/2013
 
DEREMETRX LLC



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