PRENATAL PLUS IRON

Major Pharmaceuticals

Prenatal Plus Iron Tablets

FULL PRESCRIBING INFORMATION: CONTENTS*

• PRENATAL PLUS IRON DESCRIPTION
• INDICATIONS
• DOSAGE
• WARNING
• STORAGE
• HOW SUPPLIED
• PRINCIPAL DISPLAY PANEL

FULL PRESCRIBING INFORMATION

PRENATAL PLUS IRON DESCRIPTION

Prenatal Plus Iron Tablet is caplet shaped, film coated tablet debossed CIS 28, and provides 10 vitamins and 4 minerals to supplement the diet before, during and after pregnancy.

Each Prenatal Plus tablet Contains:

Vitamin A (Acetate and Beta Carotene)............................................4000 I.U.

Vitamin C (Ascorbic acid)..................................................................120 mg

Vitamin D-3 (Cholecalciferol)...............................................................400 I.U.

Vitamin E (dl- Alpha Tocopheryl Acetate)...........................................22 I.U.

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

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

Niacin(Niacinamide).............................................................................20 mg

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

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

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

Calcium (Calcium Carbonate)...............................................................200 mg

Iron (Carbonyl Iron)..............................................................................29 mg

Zinc (Zinc Oxide).................................................................................25 mg

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

Other ingredients: Ascorbyl Palmitate, Citric Acid anhydrous, DL-alpha Tocopherol, Ethylcellulose, FD&C Blue #2 lake, FD&C Red #40 lake, FD&C Yellow # 5 lake, FD&C Yello # 6 lake, Glucose, Gum Acacia, Hypromellose, Magnesium Stearate, Maize Starch, Maltodextrin, Methylcellulose, Microcrystalline Cellulose, Mineral Oil, Mono-and di-glycerides, Polyethyelene Glycol, Pregelatinized 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 non lactating mother. It is also useful for improving nutritional status prior to conception

DOSAGE

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

STORAGE

Store at room temperature. Dispense in a well closed light resistant container with a child resistant cap.

HOW SUPPLIED

NDC 0904-5339-60 plastic bottle containing 100 Tablets.

PRINCIPAL DISPLAY PANEL

NDC 0904-5339-60

Prenatal Plus
Iron Tablets
Multivitamin/Multimineral
Supplement

For Use Before, During and
After Pregnancy.

Rx only

100 Tablets

Major®
Pharmaceuticals

CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS. YOU MAY
REPORT SIDE EFFECTS TO THE FDA AT 1-800-FDA-1088.

Keep this and all medication out of reach of children.

Do not use if imprinted seal under cap is broken or missing

Manufactured By: Cispharma, Inc, Cranbury, NJ 08512
Distributed By: Major Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI 48150 USA

PRENATAL PLUS IRON MULTIVITAMIN/MULTIMINERAL SUPPLEMENT TABLET, FILM COATED Product Information Product Type Human prescription drug label Item Code (Source) NDC:0904-5339 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VITAMIN A ACETATE 3080 [iU] .BETA.-CAROTENE .BETA.-CAROTENE 920 [iU] ASCORBIC ACID ASCORBIC ACID 120 mg CHOLECALCIFEROL CHOLECALCIFEROL 400 [iU] .ALPHA.-TOCOPHEROL ACETATE, DL- .ALPHA.-TOCOPHEROL, DL- 22 [iU] THIAMINE MONONITRATE THIAMINE ION 1.84 mg RIBOFLAVIN RIBOFLAVIN 3 mg NIACINAMIDE 20 mg PYRIDOXINE HYDROCHLORIDE PYRIDOXINE 10 mg FOLIC ACID FOLIC ACID 1 mg Cyanocobalamin CYANOCOBALAMIN 12 ug CALCIUM CARBONATE 200 mg IRON PENTACARBONYL FERROUS CATION 29 mg Zinc Oxide Zinc oxide 25 mg CUPRIC OXIDE CUPRIC CATION 2 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE CROSCARMELLOSE SODIUM CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS FD&C BLUE NO. 2 ALUMINUM OXIDE FD&C RED NO. 40 FD&C YELLOW NO. 5 ALUMINUM OXIDE FD&C YELLOW NO. 6 ALUMINUM OXIDE HYPROMELLOSES MAGNESIUM STEARATE cellulose, microcrystalline STARCH, CORN propylene glycol STEARIC ACID titanium dioxide ASCORBYL PALMITATE ANHYDROUS CITRIC ACID .ALPHA.-TOCOPHEROL ACETATE, DL- ETHYLCELLULOSE (100 MPA.S) ANHYDROUS DEXTROSE ACACIA maltodextrin METHYLCELLULOSE (1500 MPA.S) LIGHT MINERAL OIL CAPRYLIC/CAPRIC MONO/DIGLYCERIDES TRICALCIUM PHOSPHATE METHYL SORBATE SOY PROTEIN Product Characteristics Color Size Imprint Code Shape YELLOW (TAN) 18 mm CIS28 CAPSULE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0904-5339-60 100 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date 2011-06-07