PRENATAL, DHA- thiamine mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, ascorbic acid, niacin, folic acid, fe

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J), RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR), PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z), CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204), ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R), NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A), FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8), FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS C

Available from:

PureTek Corporation

INN (International Name):

THIAMINE MONONITRATE

Composition:

THIAMINE 3 mg

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Prenatal + DHA™ is indicated to provide vitamin/mineral and DHA omega-3 fatty acid supplement to women throughout pregnancy, during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. Prenatal + DHA™ 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:

Prenatal + DHA™ is supplied as six child-resistant blister cards containing 5 Prenatal + DHA™ tablets and 5 Prenatal + DHA™ softgels each - NDC 59088-096-58. 

Authorization status:

unapproved drug other

Summary of Product characteristics

PRENATAL, DHA- THIAMINE MONONITRATE, RIBOFLAVIN, PYRIDOXINE
HYDROCHLORIDE,
CYANOCOBALAMIN, ASCORBIC ACID, NIACIN, FOLIC ACID, FERROUS FUMARATE,
CALCIUM CARBONATE,
CHOLECALCIFEROL, VITAMIN E ACETATE, POTASSIUM IODIDE, ZINC OXIDE,
CHOLINE BITARTRATE, AND
DOCONEXENT
PURETEK CORPORATION
_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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PRENATAL + DHA
PRENATAL MULTI-VITAMIN / MINERAL TABLETS WITH CHOLINE BITARTRATE AND
DHA SOFTGELS
DES CRIPTION:
Prenatal + DHA™ includes a light pink coated oblong-shaped tablet
with “P658” debossed on one side
of the tablet and a natural DHA softgel containing a pale orange oil.
EACH TABLET CONTAINS:
Vitamin B1 (Thiamin Mononitrate)
3 mg
Vitamin B2 (Riboflavin)
3 mg
Vitamin B6 (Pyridoxine HCl)
50 mg
Vitamin B12 (Cyanocobalamin)
8 mcg
Vitamin C (Ascorbic acid)
120 mg
Niacin (Niacinamide)
20 mg
Folic acid
1 mg
Iron (Ferrous Fumarate)
27 mg
Calcium (Calcium Carbonate)
200 mg
Vitamin D3 (Cholecalciferol)
10.3 mcg
Vitamin E (DL-Alpha Tocopheryl Acetate)
27 mg
Iodine (Potassium Iodide)
150 mcg
Zinc (Zinc Oxide)
15 mg
Choline Bitartrate
55 mg
TABLET INACTIVE INGREDIENTS:
Maltodextrin, Microcrystalline Cellulose, Croscarmellose Sodium,
Modified Starch, Polyvinyl
Alcohol, Titanium Dioxide, Polyethylene Glycol, Citric Acid, Talc,
Silica, Stearic Acid, Magnesium
Stearate, Calcium Sulfate, Bovine Gelatin Hydrolyzed, Sucrose,
Dicalcium Phosphate, Corn Starch,
Silicon Dioxide, FD&C Red #40/Allura Red AC Aluminum Lake, Partially
Hydrogenated Soybean
Oil, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, FD&C Blue
#1/Brilliant Blue FCF
Aluminum Lake.
EACH DHA SOFTGEL CONTAINS:
DHA is an OMEGA-3 FATTY ACID. The DHA in Prenatal + DHA™ is derived
from Algal Oil (C.cohnii). 625 mg of Algal Oil is equivalent to 250 mg
of
DHA.
OTHER INGREDIENTS IN THE DHA SOFTGEL: Gelatin, High Oleic Sunflower
Oil,
Docosahexaenoic Acid (DHA) from Algal Oil
250 mg
Glycerin,