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Prenatal Plus

Package insert / prescribing information
Generic name: vitamin a acetate, beta carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, ferrous fumarate, zinc oxide and cupric oxide
Dosage form: tablet, film coated
Drug classes: Iron products, Vitamin and mineral combinations

Medically reviewed by Drugs.com. Last updated on Apr 1, 2022.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. Read further information about unapproved drugs.

Prenatal Plus Description

Prenatal Plus Vitamin and Mineral Tablet is an orally administered prenatal / postnatal prescription dietary supplement for both lactating and non-lactating mothers and should be administered under the supervision of a licensed medical practitioner.

Indications and Usage for Prenatal Plus

To provide Vitamin and Mineral supplementation throughout pregnancy and during the postnatal period for both the lactating and non-lactating mother. It is also useful for improving nutritional status prior to conception.

Warnings

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under age 6. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or Poison Control Center immediately.

Precautions

High levels of folic acid may, especially in older adults, hide signs of Vitamin B-12 deficiency (such as pernicious anemia), a condition that can cause nerve damage.

Call your licensed medical practitioner about side effects.

To report a serious adverse event or obtain product information, contact AvKARE at 1-855-361-3993; email drugsafety@avkare.com

Prenatal Plus Dosage and Administration

Before, during and/or after pregnancy, one tablet daily with a meal, or as directed by a licensed medical practitioner.

How is Prenatal Plus Supplied

Prenatal Plus Vitamin and Mineral Tablets are beige colored tablets, debossed with "677" on one side, dispensed in bottles of 100 tablets (NDC 50268-677-01)

Storage

STORE AT CONTROLLED ROOM TEMPERATURE 15º to 30ºC (59º to 86ºF).

Protect from light and moisture. Dispense in a tight, light-resistant container with child-resistant closure.

Manufactured for:

AvKARE

Pulaski, TN 38478

Rev. 11/2021

AV Rev. 11/2021

PRINCIPAL DISPLAY PANEL

Prenatal Plus
vitamin a acetate, .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, ferrous fumarate, zinc oxide, cupric oxide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:50268-677
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
.ALPHA.-TOCOPHEROL ACETATE, DL- (.ALPHA.-TOCOPHEROL, DL-) .ALPHA.-TOCOPHEROL, DL- 9.9 mg
VITAMIN A ACETATE (VITAMIN A) VITAMIN A 3080 [iU]
BETA CAROTENE (BETA CAROTENE) BETA CAROTENE 920 [iU]
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 120 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU]
THIAMINE MONONITRATE (THIAMINE ION) THIAMINE 1.84 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 3 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 20 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 10 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 12 ug
CALCIUM CARBONATE (CALCIUM CATION) CALCIUM CATION 200 mg
FERROUS FUMARATE (FERROUS CATION) FERROUS CATION 27 mg
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 25 mg
CUPRIC OXIDE (CUPRIC CATION) CUPRIC CATION 2 mg
Inactive Ingredients
Ingredient Name Strength
ASCORBYL PALMITATE
BUTYLATED HYDROXYTOLUENE
CROSCARMELLOSE SODIUM
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
.ALPHA.-TOCOPHEROL, DL-
FD&C RED NO. 40
FD&C YELLOW NO. 5
FD&C YELLOW NO. 6
GELATIN
HYPROMELLOSES
MAGNESIUM STEARATE
MALTODEXTRIN
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
PROPYLENE GLYCOL
SILICON DIOXIDE
SODIUM ASCORBATE
SODIUM BENZOATE
SORBIC ACID
STARCH, CORN
STEARIC ACID
SUCROSE
SUNFLOWER OIL
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color gray (Beige) Score no score
Shape OVAL Size 19mm
Flavor Imprint Code 677
Contains
Packaging
# Item Code Package Description
1 NDC:50268-677-01 100 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 03/16/2022
Labeler - AvPAK (832926666)
AvPAK