PRENATAL 19- folic acid, .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate,

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8), 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, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01), THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J), RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR), NIA

Available from:

Nationwide Laboratories, LLC

INN (International Name):

FOLIC ACID

Composition:

FOLIC ACID 1 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

PreNatal 19 chewable tablets are indicated for use in improving the nutritional status of women throughout pregnancy and in postnatal period for both lactating and non-lactating mothers. PreNatal 19 chewable tablets are also useful 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 19 chewable tablets for oral administration are supplied as multi-color-speckled,round tablets debossed "C43", packaged in bottles of 100 tablets. Dispense in a tight, light–resistant container as defined in the USP/NF with child-resistant closure. Store at 20°-25°C (68°-77°F) [see USP controlled room temperature]. Protect from moisture and excessive heat. Avoid freezing.

Authorization status:

unapproved drug other

Summary of Product characteristics

PRENATAL 19- FOLIC ACID, .BETA.-CAROTENE, ASCORBIC ACID,
CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL
ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE,
PYRIDOXINE HYDROCHLORIDE,
CYANOCOBALAMIN, CALCIUM PANTOTHENATE, CALCIUM CARBONATE, FERROUS
FUMARATE, AND ZINC
OXIDE TABLET, CHEWABLE
NATIONWIDE LABORATORIES, 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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PRENATAL 19
DESCRIPTION
PreNatal 19 chewable tablets are round, debossed "C43". These tablets
provide oil-soluble vitamins
and minerals.
EACH TABLET HAS THE FOLLOWING ACTIVE INGREDIENT:
Folate (folic acid)
1 mg
EACH TABLET ALSO CONTAINS THE FOLLOWING
INGREDIENTS FOR NUTRITIONAL SUPPLEMENT:
VITAMIN A (as beta carotene)
1000 IU
VITAMIN C (as ascorbic acid)
100 mg
VITAMIN D (as cholecalciferol)
400 IU
VITAMIN E (as dl-alpha-tocopheryl
acetate)
30 IU
THIAMINE (Vitamin B )
(thiamine mononitrate)
3 mg
RIBOFLAVIN (Vitamin B )
3 mg
NIACIN (as niacinamide)
15 mg
VITAMIN B (as pyridoxine HCl)
20 mg
VITAMIN B
(as cyanocobalamine)
12 mcg
PANTOTHENIC ACID (as calcium
pantothenate)
7 mg
CALCIUM (as calcium carbonate)
200 mg
IRON (as ferrous fumarate)
29 mg
ZINC (as zinc oxide)
20 mg
OTHER INGREDIENTS:
Flavors, magnesium stearate, maltodextrin, mannitol, silicon dioxide,
stearic acid, sucralose and
sucrose.
INDICATIONS
PreNatal 19 chewable tablets are indicated for use in improving the
nutritional status of women
throughout pregnancy and in postnatal period for both lactating and
non-lactating mothers. PreNatal 19
chewable tablets are also useful in improving the nutritional status
of women prior to conception.
CONTRAINDICATIONS
1
2
6
12
This product is contraindicated in patients with a known
hypersensitivity to any of the ingredients.
WARNINGS
Folic acid alone is improper therapy in the treatment of pernicious
anemia and other megaloblastic
anemias where Vitamin B
is deficient.
WARNING
ACCIDENTAL OVERDOSE OF IRON-CONTAININ