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PreNatal Vitamins Plus

Generic Name: multi-vitamins
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.

PreNatal Vitamins Plus LOW IRON

Supplemental Facts 
 Each tablet Contains:  Amount per Tablet  % Daily Value
 Vitamin A (Acetate and Beta Carotene)  4000 I.U.  80%
 Vitamin C (Ascorbic acid)  120 mg        200%
 Vitamin D-3 (Cholecalciferol)  400 I.U.  100%
 Vitamin E (dl-Alpha Tocopheryl Acetate)  22 mg  73%
 Vitamin B-1 (Thiamine Mononitrate)  1.84 mg  123%
 Vitamin B-2 (Riboflavin)  3 mg  176%
 Niacin (Niacinaminde)  20 mg  100%
 Vitamin B-6 (Pyridoxine HCL)  10 mg  500%
 Folic Acid  1 mg  200%
 Vitamin B-12 (Cyanocobalamin)  12 mcg  200%
 Calcium (from Calcium Carbonate)  200 mg  20%
 Iron (Ferrous Fumarate  27 mg  150%
 Zinc (Zinc Oxide)  25 mg  167%
 Copper (Cupric Oxide)  2 mg  100%
     

 

Other Ingredients:

Corn Starch, Dicalcium Phosphate, DL Alpha Tocopherol, FD&C: Blue #2 Lake, FD&C: Red #40 Lake, FD&C: Yellow #6 Lake, Gum Arabic, Hydroxypropyl Methylcellulose, Maltodextrin, Microcrystalline Cellulose, Modified food starch, Polyethylene Glycol (PEG), Polyvinyl Alcohol, Pregelatinized Starch, Silicon Dioxide, Sucrose, Talc, Titanium Dioxide.

Directions:

Before, during and after pregnancy, one tablet daily or as directed by physician.

Caution:

Folic Acid may partially correct the hematological damage due to Vitamin B-12 deficiency or pernicious anemia while the associated neurological damage progresses.

Warning:

Accidental overdose of iron-containing products is a leading cause of fetal poisoning in children under six.

KEEP THIS PRODUCT OUT OF REACH OF CHILDREN.

In case of acciential overdose, call a physician or Poison Control Center immediately.

Indications:

To promote 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.

Contraindications:

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Storage:

Store at room temperature, USP. Dispense in a well closed light resistant container.

Safety Information:

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

PreNatal Vitamins Plus
Low iron tablets product label

Rx Only NDC 63044-150-05

PreNatal Vitamins Plus
Low iron tablets

Vitamins and Mineral
Supplement for pregnant
& lactating women

ZIKS Nnodum Pharmaceuticals

500 Tablets

Manufactured for: Nnodum Pharmaceuticals
Cincinnati, OH 45240 (513) 861-2329
MADE IN THE USA

PreNatal Vitamins Plus 
vitamin a, vitamin c, vitamin d-3, vitamin e, vitamin b-1, vitamin b-2, niacin, vitamin b-6, calcium, iron, zinc, copper tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:63044-150
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VITAMIN A ACETATE (VITAMIN A) VITAMIN A 4000 [iU]
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 120 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU]
.ALPHA.-TOCOPHEROL ACETATE (.ALPHA.-TOCOPHEROL) .ALPHA.-TOCOPHEROL ACETATE 22 mg
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 CARBONATE 200 mg
FERROUS FUMARATE (FERROUS CATION) FERROUS CATION 27 mg
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 25 mg
COPPER (COPPER) COPPER 2 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE  
FD&C BLUE NO. 2  
FD&C RED NO. 40  
FD&C YELLOW NO. 6  
ACACIA  
HYPROMELLOSES  
MALTODEXTRIN  
CELLULOSE, MICROCRYSTALLINE  
POLYETHYLENE GLYCOLS  
POLYVINYL ALCOHOL  
STARCH, PREGELATINIZED CORN  
SILICON DIOXIDE  
SUCROSE  
TALC  
TITANIUM DIOXIDE  
Product Characteristics
Color orange (peach) Score no score
Shape OVAL Size 7mm
Flavor Imprint Code N150
Contains         
Packaging
# Item Code Package Description
1 NDC:63044-150-01 100 TABLET in 1 BOTTLE, PLASTIC
2 NDC:63044-150-05 500 TABLET in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 02/25/2016
Labeler - Nnodum Pharmaceuticals (960457273)
Registrant - Nnodum Pharmaceuticals (960457273)
Revised: 03/2016
 
Nnodum Pharmaceuticals



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