Prenatal Plus Iron

Name: Prenatal Plus Iron

Precautions

Folic acid may partially correct the hematological damage due to Vitamin B12 deficiency of pernicious anemia, while the associated neurological damage progresses.

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 Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

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

CALL YOUR DOCTOR FOR MEDICAL ADVISE ABOUT SIDE EFFECTS. YOU MAY REPORT SIDE EFFECTS TO THE FDA AT 1-800-FDA-1088 (TOLL FREE).

Keep this and all medication out of the reach of children.

Do not use if imprinted Safety Seal under cap is broken or missing.

Distributed by: Nationwide Laboratories, Iselin NJ 08830

Lot No.: Exp. Date: Rev. 7/12

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

Nationwide Laboratories LLC

NDC 42937-705-10

Prenatal Plus
Iron Tablets

Multivitamin/Multimineral
Supplement

For Use Before, During
and After Pregnancy.

Rx only

100 Tablets

PRENATAL PLUS 
vitamin a, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, iron, zinc oxide, and cupric oxide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:42937-705
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Vitamin A (Vitamin A) Vitamin A 4000 [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 1.84 mg
Riboflavin (Riboflavin) Riboflavin 3 mg
Niacinamide (Niacinamide) Niacinamide 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 and Carbonate Ion) Calcium Carbonate 200 mg
Iron (Iron) Iron 29 mg
Zinc Oxide (Zinc Oxide) Zinc Oxide 25 mg
Cupric Oxide (Cupric Cation) Cupric Cation 2 mg
Inactive Ingredients
Ingredient Name Strength
Ascorbyl Palmitate  
Anhydrous Citric Acid  
.Alpha.-Tocopherol, Dl-  
Ethylcelluloses  
FD&C Blue No. 2  
Aluminum Oxide  
FD&C Red No. 40  
FD&C Yellow No. 5  
FD&C Yellow No. 6  
Dextrose  
Acacia  
Hypromelloses  
Magnesium Stearate  
Starch, Corn  
Maltodextrin  
Cellulose, Microcrystalline  
Mineral Oil  
Polyethylene Glycols  
Silicon Dioxide  
Sorbic Acid  
Soy Protein  
Stearic Acid  
Sucrose  
Titanium Dioxide  
Tricalcium Phosphate  
Product Characteristics
Color YELLOW (Tan) Score no score
Shape OVAL Size 18mm
Flavor Imprint Code CIS;28
Contains     
Packaging
# Item Code Package Description
1 NDC:42937-705-10 100 TABLET in 1 BOTTLE
2 NDC:42937-705-16 250 TABLET in 1 BOTTLE
3 NDC:42937-705-18 500 TABLET in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 06/01/2011
Labeler - Nationwide Laboratories (078366153)
Revised: 07/2015   Nationwide Laboratories
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