Prenatal Plus Iron

Generic Name: multivitamin, multimineral supplement

Dosage Form: tablet, film coated


Prenatal Plus Iron Tablet is an oval shaped, film coated tablet debossed G13 on one side, 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 mg


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


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


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


Other ingredients: Amorphous fumed silica,Colloidal silica, Croscarmellose sodium, Dicalcium phosphate, FD&C Blue # 6 lake, FD&C Red #40 lake, FD&C yellow # 5 lake, FD&C yellow # 6 lake, Hydroxypropyl methylcellulose, Magnesium stearate, Microcrystalline cellulose, Pregelatinized corn starch, propylene glycol, Stearic acid, Titanium dioxide, Triacetin

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

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

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.

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

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

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-1033.


Keep this and all medication out of reach of children.


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

Manufactured By: Gemini Pharmaceuticals, Commack, NY 11725

Distributed By: Major Pharmaceuticals, Livonia, MI 48150

PRENATAL PLUS  IRON TABLETS multivitamin/multimineral supplement  tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0904-5339 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 (VITAMIN A) VITAMIN A 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) THIAMINE 1.84 mg RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 3 mg NIACINAMIDE (NIACIN) NIACIN 20 mg PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE 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 (IRON) IRON 27 mg ZINC OXIDE (ZINC CATION) ZINC CATION 25 mg CUPRIC OXIDE (COPPER) COPPER 2 mg

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE   CROSCARMELLOSE SODIUM   ANHYDROUS DIBASIC CALCIUM PHOSPHATE   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   HYPROMELLOSE   MAGNESIUM STEARATE   CELLULOSE, MICROCRYSTALLINE   STARCH, CORN   PROPYLENE GLYCOL   STEARIC ACID   TITANIUM DIOXIDE   TRIACETIN

Product Characteristics Color brown (TAN) Score no score Shape OVAL Size 19mm Flavor Imprint Code G13 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0904-5339-60 100 TABLET In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved other		10/29/2009

Labeler - Major Pharmaceuticals (191427277)

Registrant - Gemini Pharmaceuticals, Inc. (055942270)

Establishment
Name	Address	ID/FEI	Operations
Gemini Pharmaceuticals, Inc.		055942270	manufacture

Revised: 10/2009Major Pharmaceuticals

More Prenatal Plus Iron resources

• Prenatal Plus Iron Dosage
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• Prenatal Plus Iron Drug Interactions
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