DUET DHA 400- .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, d-, thiamine mononitrate, riboflavin,

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

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download SPC (SPC)
07-09-2023

active_ingredient:

.BETA.-CAROTENE (UNII: 01YAE03M7J) (.BETA.-CAROTENE - UNII:01YAE03M7J), ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R), CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41), .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9), THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J), RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR), NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4),

MAH:

Eckson Labs, LLC

INN:

.BETA.-CAROTENE

composition:

.BETA.-CAROTENE 2800 [iU]

administration_route:

ORAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

This product is a gluten free prescription regimen of prenatal multi-vitamin, multi-mineral and omega-3 fatty acid supplements indicated for use in improving the nutritional status of women throughout pregnancy and in the post-natal period for both lactating and non-lactating mothers. This product is also useful in improving the nutritional status prior to conception. This product is contraindicated in patients with known hypersensitivity to any of the ingredients, including fish or fish oil.

leaflet_short:

A 30-day regimen supplied in a carton, NDC 44118-807-30, consisting of one bottle containing 30 maroon tablets, imprinted “800”, and one bottle containing 30 softgel capsules. These child-resistant bottles are tamper evident by foil seal under cap.

authorization_status:

unapproved drug other

SPC

                                DUET DHA 400- .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL,
.ALPHA.-
TOCOPHEROL ACETATE, D-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE,
PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM
CARBONATE, IRON,
MAGNESIUM OXIDE, ZINC OXIDE, CUPRIC OXIDE, IODINE, OMEGA-3 FATTY ACIDS
ECKSON LABS, 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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DUET DHA 400
DESCRIPTION:
This product is a gluten free prescription regimen of prenatal
multi-vitamin, multi-mineral
and omega-3 fatty acids, supplied as tablets and softgel capsules.
EACH TABLET CONTAINS:
SUPPLEMENT FACTS
SERVING SIZE: 1 TABLET
AMOUNT PER
SERVING
Vitamin A (beta carotene)
2,800 IU
Vitamin C (ascorbic acid)
120 mg
Vitamin D (cholecalciferol)
820 IU
Vitamin E (dl-alpha tocopheryl acetate)
3 mg
Vitamin B
(thiamine mononitrate)
1.8 mg
Vitamin B
(riboflavin)
4 mg
Niacinamide
20 mg
Vitamin B
(pyridoxine hydrochloride)
50 mg
Folic acid
1 mg
Vitamin B
(cyanocobalamin)
12 mcg
Calcium (calcium carbonate)
200 mg
Iron (polysaccharide iron complex and sodium iron (III)
ethylenediaminetetraacetate, Ferrazone
)
25 mg
Magnesium (magnesium oxide)
25 mg
Zinc (zinc oxide)
25 mg
Copper (cupric oxide)
2 mg
Iodine
220 mcg
OTHER INGREDIENTS: microcrystalline cellulose, starch, silica,
magnesium stearate,
polyethylene glycol, polyvinyl alcohol, titanium dioxide, talc, FD&C
red no. 40 aluminum
lake, FD&C blue no. 1 & no. 2 aluminum lake
WARNING: Accidental overdose of iron-containing products is a leading
cause of fatal
1
2
6
12
®
poisoning in children under 6. Keep this product out of reach of
children. In case of
accidental overdose, call a doctor or poison control center
immediately.
EACH SOFTGEL CAPSULE CONTAINS in a clear solution of 400 mg purified
omega-3 long-
chain fatty acids including DHA (docosahexaenoic acid) and EPA
(eicosapentaenoic acid).
SUPPLEMENT FACTS
SERVING SIZE: 1 SOFTGEL CAPSULE
AMOUNT PER SERVI
                                
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