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Prenatal Plus Iron

Generic Name: multivitamin, multimineral supplement
Dosage Form: tablet

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.

Each Tablet Contains:
VITAMINS:
Amount per Tablet
Vitamin A (from Acetate and Beta Carotene) 4000 IU
Vitamin C (Ascorbic Acid) 120 mg
Vitamin D-3 (Cholecalciferol) 400 IU
Vitamin E (dl-Alpha Tocopheryl Acetate) 22 IU
Thiamine (Vitamin B-1 from Thiamine Mononitrate) 1.84 mg
Riboflavin (Vitamin B-2) 3 mg
Niacin (as Niacinamide) 20 mg
Vitamin B-6 (from Pyridoxine HCl) 10 mg
Folic Acid 1 mg
Vitamin B-12 (Cyanocobalamin) 12 mcg
MINERALS:
Calcium (from Calcium Carbonate) 200 mg
Iron (from Carbonyl Iron) 29 mg
Zinc (from Zinc Oxide) 25 mg
Copper (from 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 Yellow #6 lake, Glucose, Gum Acacia, Hypromellose, Magnesium Stearate, Maize Starch, Maltodextrin, Methylcellulose, Microcrystalline Cellulose, Mineral Oil, Mono- and di-glycerides, Polyethylene Glycol, Pregelatinzed Corn Starch, Silicon Dioxide, Sorbic Acid, Soy Protein, Stearic Acid, Sucrose, Titanium Dioxide, Tricalcium Phosphate.

Indication

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 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.

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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