PRENATAL PLUS IRON TABLETS – 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 
Major Pharmaceuticals

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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