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

Drug Labeling and Warnings

Drug Details [pdf]

DESCRIPTION

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 & USAGE

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

Contraindications:This product is contraindicated in patients with a known hypersensitivity to any of the ingredients .

WARNINGS

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

Warnings: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where B12 is deficient.

BOXED WARNING

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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

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

Adverse Reactions:  Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

DOSAGE & ADMINISTRATION

Dosage and Administration: Pre-Tabs DHA - One tablet and one soft gel capsule daily or as directed by a physician.

HOW SUPPLIED

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).

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

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	Item Code (Source)	NDC: 48948-406

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 48948-406-30	6 in 1 CARTON
1		1 in 1 BLISTER PACK

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	5 PACKAGE	5
Part 2	5 PACKAGE	5

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM ASCORBATE (UNII: S033EH8359) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	SODIUM ASCORBATE	120 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	450 [iU]
TOCOPHERSOLAN (UNII: O03S90U1F2) (TOCOPHERSOLAN - UNII:O03S90U1F2)	TOCOPHERSOLAN	30 [iU]
THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J)	THIAMINE	3 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR)	RIBOFLAVIN	3 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	20 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE	50 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	10 ug
CALCIUM FORMATE (UNII: NP3JD65NPY) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	155 mg
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	45 mg
FERROUS BISGLYCINATE (UNII: SFW1D987QV) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	32 mg
POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q)	IODIDE ION	100 ug
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	10 mg
CHOLINE BITARTRATE (UNII: 6K2W7T9V6Y) (CHOLINE - UNII:N91BDP6H0X)	CHOLINE	55 mg

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYVINYL ALCOHOL (UNII: 532B59J990)
POVIDONE (UNII: FZ989GH94E)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
TALC (UNII: 7SEV7J4R1U)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Characteristics
Color	blue (LIGHT BLUE)	Score	2 pieces
Shape	OVAL	Size	18mm
Flavor		Imprint Code	WC;001
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		1 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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC)	DOCONEXENT	230 mg
ICOSAPENT (UNII: AAN7QOV9EA) (ICOSAPENT - UNII:AAN7QOV9EA)	ICOSAPENT	30 mg
ALPHA-TOCOPHEROL, D- (UNII: N9PR3490H9) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9)	ALPHA-TOCOPHEROL, D-	2 [iU]

Inactive Ingredients
Ingredient Name	Strength
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	yellow	Score	no score
Shape	capsule	Size	6mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		1 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)