NATELLE ONE- doconexent, icosapent, calcium, iron, ascorbic acid, pyridoxine, .alpha.-tocopherol, folic acid capsule, gelatin co

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC), ICOSAPENT (UNII: AAN7QOV9EA) (ICOSAPENT - UNII:AAN7QOV9EA), CALCIUM (UNII: SY7Q814VUP) (CALCIUM - UNII:SY7Q814VUP), IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7), ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R), PYRIDOXINE (UNII: KV2JZ1BI6Z) (PYRIDOXINE - UNII:KV2JZ1BI6Z), .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1), FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)

Available from:

MEDA Pharmaceuticals

INN (International Name):

DOCONEXENT

Composition:

DOCONEXENT 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Natelle® One is indicated to provide vitamin/mineral and DHA omega–3 fatty acid supplementation to women throughout pregnancy, during the postnatal period for both lactating and non–lactating mothers, and throughout the childbearing years. Natelle® One may be beneficial in improving the nutritional status of women prior to conception. This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Product summary:

Supplied in child resistant bottles of 30 capsules (NDC 0037-6072-30). Store at controlled room temperature 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). KEEP THIS AND ALL DRUGS/MEDICATIONS OUT OF THE REACH OF CHILDREN.

Authorization status:

unapproved drug other

Summary of Product characteristics

NATELLE ONE- DOCONEXENT, ICOSAPENT, CALCIUM, IRON, ASCORBIC ACID,
PYRIDOXINE, .ALPHA.-
TOCOPHEROL, FOLIC ACID CAPSULE, GELATIN COATED
MEDA PHARMACEUTICALS
_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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NATELLE
ONE
Rx Prenatal Vitamin & Plant-Based DHA.
Now with 28 mg iron
BOXED WARNING
WARNING: ACCIDENTAL OVERDOSE OF IRON-CONTAINING PRODUCTS IS A LEADING
CAUSE OF FATAL
POISONING IN CHILDREN UNDER 6 YEARS OF AGE. KEEP THIS PRODUCT OUT OF
THE REACH OF CHILDREN. IN
CASE OF ACCIDENTAL OVERDOSE, CALL A DOCTOR OR POISON CONTROL CENTER
IMMEDIATELY.
DESCRIPTION
Natelle® One capsules for oral administration are supplied as oblong
red soft gelatin capsules,
imprinted with "Natelle1" in white ink.
EACH CAPSULE CONTAINS:
Docosahexaenoic Acid (DHA) from Algal
Oil..................................250 mg
Eicosapentaenoic Acid (EPA).................................Not more
than 0.625mg
Calcium (Tricalcium
Phosphate).......................................................102
mg
Iron (Ferrous Fumarate)
...................................................................28
mg
Vitamin C (Ascorbic Acid)
...............................................................30 mg
Vitamin B-6 (Pyridoxine HCl)
...........................................................25 mg
Vitamin E (D-Alpha Tocopherol)
......................................................30 IU
Folic Acid
..........................................................................................1
mg
DHA is an omega-3 fatty acid. 250 mg of DHA from 625 mg of algal oil
is derived from
Crypthecodinium cohnii. DHA is derived from the oils of microalgae,
which is grown outside of the
ocean, in a controlled environment, eliminating the risk of oceanic
contamination.
INACTIVE INGREDIENTS: Gelatin (Bovine), Beeswax, Glycerine, Soybean
Oil, Lecithin, Titanium Dioxide,
Ethyl Vanillin.
INDICATIONS AND USAGE
Natelle® One is indicated to prov