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Prenatal Plus Iron

Generic Name: multivitamin, multimineral supplement
Dosage Form: tablet, film coated

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.

Prenatal Plus Iron Tablets

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.

Slideshow: OTC Medication Use In Pregnancy: Wise or Worrisome?

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.

Warning

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.

This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yello No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

STORAGE

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

How is Prenatal Plus Iron 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 (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 [iU]
THIAMINE MONONITRATE (Thiamine ION) Thiamine ION 1.84 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 3 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 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
IRON PENTACARBONYL (IRON PENTACARBONYL) IRON PENTACARBONYL 29 mg
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 25 mg
CUPRIC OXIDE (CUPRIC OXIDE) CUPRIC OXIDE 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 YELLOW (TAN) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code CIS28
Contains         
Packaging
# Item Code Package Description
1 NDC:0904-5339-60 100 TABLET, FILM COATED (100 TABLET) in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 06/07/2011
Labeler - Major Pharmaceuticals (191427277)
Revised: 12/2012
 
Major Pharmaceuticals



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