PRENATAL PLUS

PRENATAL PLUS- vitamin a acetate, .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, ferrous fumarate, zinc oxide and cupric oxide tablet, film coated
Carilion Materials Management

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.

HOW SUPPLIED

NDC:68151-2640-1 in a PACKAGE of 1 TABLET, FILM COATEDS

Storage

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

Dispense in a well closed light-resistant container, with a child resistant cap.
KEEP THIS AND ALL MEDICATION OUR OF THE REACH OF CHILDREN.
DO NOT USE IF INNER SAFETY SEAL IS BROKEN OR MISSING.

Manufactured by: Colorado Springs, CO 80905
Nexgen Pharma

Distributed by: Glasgow, KY 42141
Amneal Pharmaceuticals

Rev. 09-2012

Prenatal Plus Vitamins tabs

Label ImageLabel 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:68151-2640(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 (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 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:68151-2640-1 1 TABLET, FILM COATED (1 TABLET) in 1 PACKAGE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 12/02/2009
Labeler — Carilion Materials Management (079239644)
Registrant — Carilion Materials Management (079239644)
Establishment
Name Address ID/FEI Operations
Carilion Materials Management 079239644 REPACK (68151-2640)

Revised: 04/2013 Carilion Materials Management

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