PRENATAL PLUS: Package Insert and Label Information

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 and cupric oxide tablet, film coated
Atlantic Biologicals Corps

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.

DESCRIPTION

Each Tablet Contains:

VITAMINS: Amount per Tablet

Vitamin A (from Acetate and Beta Carotene) ……………………….. 4000 IU

Vitamin C (Ascorbic Acid) ………………………………………………….. 120 mg

Vitamin D-3 (Cholecalciferol) ………………………………………………. 400 IU

Vitamin E (dl- Alpha Tocopheryl Acetate) ……………………………….. 22 IU

Thiamine (Vitamin B-1) (from Thiamine Mononitrate) …………….. 1.84 mg

Riboflavin (Vitamin B-2) ………………………………………………………… 3 mg

Niacin (as Niacinamide) ………………………………………………………. 20 mg

Vitamin B-6 (Pyridoxine HCl) ………………………………………………… 10 mg

Folic Acid …………………………………………………………………………….. 1 mg

Vitamin B-12 (Cyanocobalamin) …………………………………………… 12 mcg

MINERALS: Amount per Tablet

Calcium (as Calcium Carbonate) …………………………………………. 200 mg

Iron (from Ferrous Fumarate) ……………………………………………….. 27 mg

Zinc (from Zinc Oxide) …………………………………………………………. 25 mg

Copper (from Cupric Oxide) ………………………………………………….. 2 mg

croscarmellose sodium, FD&C Blue #2, FD&C Red #40, FD&C Yellow # 5, FD&C Yellow # 6, macrogol, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, silicon, starch, stearic acid, talc, titanium dioxide Other ingredients:

INDICATIONS AND USAGE

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

Folic acid may partially correct the hematological damage due to Vitamin B12 deficiency of pernicious anemia, while the associated neurological damage progesses.

DOSAGE AND ADMINISTRATION

As a dietary adjunct before, during and after pregnancy, take one tablet daily with a meal, or as directed by a physician.

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

Label Image

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 Item Code (Source) NDC:17856-0668(NDC:65162-668) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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] .ALPHA.-TOCOPHEROL ACETATE, DL- (.ALPHA.-TOCOPHEROL, DL-) .ALPHA.-TOCOPHEROL, DL- 22 mg 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 (CARBONATE ION) CALCIUM CARBONATE 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 GLYCOLS PROPYLENE GLYCOL SILICON DIOXIDE SODIUM ASCORBATE SODIUM BENZOATE SORBIC ACID STARCH, CORN STEARIC ACID SUCROSE SUNFLOWER OIL TITANIUM DIOXIDE TRIACETIN

Product Characteristics Color YELLOW Score no score Shape OVAL Size 19mm Flavor Imprint Code G12 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:17856-0668-1 1 TABLET, FILM COATED (1 TABLET) in 1 POUCH None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 12/02/2009

Labeler — Atlantic Biologicals Corps (047437707)

Registrant — Atlantic Biologicals Corps (047437707)

Establishment
Name	Address	ID/FEI	Operations
Atlantic Biologicals Corps		047437707	RELABEL (17856-0668), REPACK (17856-0668)

Revised: 04/2013 Atlantic Biologicals Corps