PRENATE DHA- ascorbic acid, cholecalciferol, .alpha.-tocopherol, dl-, folic acid, pyridoxine hydrochloride, cyanocobalamin, calcium formate, ferrous asparto glycinate, magnesium oxide and doconexent capsule, gelatin coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R), CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41), .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01), FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8), PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z), CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204), CALCIUM FORMATE (UNII: NP3JD65NPY) (CALCIUM CATION - UNII:2M83C4R6ZB), FERROUS ASPARTO GLYCINATE (UNII: H7426RGB3L) (FERROUS CATION - UNII:GW89581OWR), MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838), DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC)

Available from:

Avion Pharmaceuticals, LLC

INN (International Name):

ASCORBIC ACID

Composition:

ASCORBIC ACID 90 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

INDICATIONS: PRENATE DHA ® is a multivitamin/multimineral fatty acid dietary supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers. PRENATE DHA ® can also be beneficial in improving the nutritional status of women prior to conception. CONTRAINDICATIONS: PRENATE DHA ® is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Product summary:

HOW SUPPLIED: Bottles of 30 softgels (75854-312-30). The listed product number is not a National Drug Code. Instead, Avion Pharmaceuticals has assigned a product code formatted according to standard industry practice to meet the formatting requirements of pharmacy and healthcare insurance computer systems.

Authorization status:

unapproved drug other

Summary of Product characteristics

PRENATE DHA- ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-,
FOLIC ACID,
PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, CALCIUM FORMATE, FERROUS
ASPARTO
GLYCINATE, MAGNESIUM OXIDE AND DOCONEXENT CAPSULE, GELATIN COATED
AVION PHARMACEUTICALS, 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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_PRENATE _DHA
RX ONLY DIETARY SUPPLEMENT
DESCRIPTION: PRENATE DHA
is a prescription prenatal/postnatal
multivitamin/mineral/essential fatty acid softgel. Each softgel is
blue in color, opaque, and
imprinted with “DHA” on one side and blank on the other.
PRENATE DHA
contains fish oil and soy.
OTHER INGREDIENTS: Gelatin capsule (FD&C Blue #1, FD&C Red #3,
gelatin, glycerin,
®
®
®
purified water, sorbitol and titanium dioxide), soybean oil, soy
lecithin, and white
beeswax.
INDICATIONS: PRENATE DHA
is a multivitamin/multimineral fatty acid dietary
supplement indicated for use in improving the nutritional status of
women throughout
pregnancy and in the postnatal period for both lactating and
nonlactating mothers.
PRENATE DHA
can also be beneficial in improving the nutritional status of women
prior
to conception.
CONTRAINDICATIONS: PRENATE DHA
is contraindicated in patients with a known
hypersensitivity to any of the ingredients.
WARNING: Ingestion of more than 3 grams of omega-3 fatty acids (such
as DHA) per
day has been shown to have potential antithrombotic effects, including
an increased
bleeding time and International Normalized Ratio (INR). Administration
of omega-3 fatty
acids should be avoided in patients taking anticoagulants and in those
known to have an
inherited or acquired predisposition to bleeding.
PRECAUTIONS: Folic acid alone is improper therapy in the treatment of
pernicious
anemia and other megaloblastic anemias where Vitamin B
is deficient. Folic acid in
doses above 1.0 mg daily may obscure pernicious anemia in that
hematologic remission
can occur whil