Prenatal Vitamins Plus Low Iron

PRENATAL VITAMINS PLUS LOW IRON- vitamin a acetate, .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine, riboflavin, niacin, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, iron, zinc and copper tablet
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.

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Each Tablet Contains: Amount
Per Tablet
% Daily
Value
Vitamin A (from Acetate and Beta Carotene) 4000 IU 80%
Vitamin C (Ascorbic Acid) 120 mg 200%
Vitamin D-3 (Cholecalciferol) 400 IU 100%
Vitamin E (dl-Alpha Tocopheryl Acetate) 22 mg 73%
Vitamin B-1(Thiamine Mononitrate) 1.84 mg 123%
Vitamin B-2 (Riboflavin) 3 mg 176%
Niacin (as Niacinamide) 20 mg 100%
Vitamin B-6 (Pyridoxine HCI) 10 mg 500%
Folic Acid 1 mg 200%
Vitamin B-12 (Cyanocobalamin) 12 mcg 200%
Calcium (from Calcium Carbonate) 200 mg 20%
Iron (Ferrous Fumarate) 27 mg 150%
Zinc (Zinc Oxide) 25mg 167%
Copper (Cupric Oxide) 2 mg 100%

Other Ingredients: Ascorbyl Palmitate, Citric Acid anhydrous, DL- alpha Tocopherol, Ethylcellulose, FD&C Blue #2 lake, FD&C Red #40 lake, FD&C Yellow #6 lake, Glucose, Gum Acacia, Hypromellose, Magnesium Stearate, Maize Starch, Maltodextrin, Methylcellulose, Microcrystalline Cellulose, Mineral Oil, Mono and di-glycerides, Polyethylene Glycol, Pregelatinzed Corn Starch, Silicon Dioxide, Sorbic Acid, Soy Protein, Stearic Acid, Sucrose, Titanium Dioxide, Tricalcium Phosphate.

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

Directions: Before, during and after pregnancy, one tablet daily or as directed by a physician.

Contraindications: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Caution: Folic Acid may partially correct the hematological damage due to Vitamin B-12 deficiency of pernicious anemia while the associated neurological damage progresses.

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under six. KEEP THIS PRODUCT OUT OF REACH OF CHILDREN. In case of accidental overdose, call a physician or Poison Control Center immediately.

Store at room temperature, USP. Dispense in a well closed light resistant container.

HOW SUPPLIED

Product: 68151-5878

NDC: 68151-5878-1 1 TABLET in a BLISTER PACK

PRENATAL VITAMINS PLUS LOW IRON (PRENATAL WITH FERROUS FUM AND FOLIC ACID) TABLET

Label ImageLabel Image
PRENATAL VITAMINS PLUS LOW IRON
prenatal with ferrous fum and folic acid tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68151-5878(NDC:39328-106)
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
NIACIN (NIACIN) NIACIN 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
IRON (IRON) IRON 27 mg
ZINC (ZINC) ZINC 25 mg
COPPER (COPPER) COPPER 2 mg
Inactive Ingredients
Ingredient Name Strength
ASCORBYL PALMITATE
ANHYDROUS CITRIC ACID
.ALPHA.-TOCOPHEROL, DL-
ETHYLCELLULOSE, UNSPECIFIED
FD&C BLUE NO. 2
FD&C RED NO. 40
FD&C YELLOW NO. 6
DEXTROSE, UNSPECIFIED FORM
ACACIA
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
STARCH, CORN
MALTODEXTRIN
METHYLCELLULOSE (100 MPA.S)
MICROCRYSTALLINE CELLULOSE
MINERAL OIL
GLYCERYL MONOSTEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
SILICON DIOXIDE
SORBIC ACID
SOY PROTEIN
STEARIC ACID
SUCROSE
TITANIUM DIOXIDE
TRICALCIUM PHOSPHATE
Product Characteristics
Color brown (Beige) Score no score
Shape OVAL (OVAL) Size 9mm
Flavor Imprint Code P;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68151-5878-1 1 TABLET in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 04/01/2013
Labeler — Carilion Materials Management (079239644)
Establishment
Name Address ID/FEI Operations
Carilion Materials Management 079239644 REPACK (68151-5878)

Revised: 12/2017 Carilion Materials Management

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