PRE-TABS DHA PRENATAL MULTI-VITAMIN/MINERAL SUPPLEMENT WITH DHA/EPA (sodium ascorbate, cholecalciferol, di-alpha-tocopheryl acet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SODIUM ASCORBATE (UNII: S033EH8359) (ASCORBIC ACID - UNII:PQ6CK8PD0R), CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41), TOCOPHERSOLAN (UNII: O03S90U1F2) (TOCOPHERSOLAN - UNII:O03S90U1F2), THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J), RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR), NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4), PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z), FOLIC ACID (UNII:

Available from:

DEREMETRX LLC

INN (International Name):

SODIUM ASCORBATE

Composition:

SODIUM ASCORBATE 120 mg

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 .

Product summary:

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).

Authorization status:

unapproved drug other

Summary of Product characteristics

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
DEREMETRX LLC
_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._
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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
P