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Prenatal Vitamins Plus Low Iron

Generic Name: vitamin a acetate, beta carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine, riboflavin, niacin, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, iron, zinc and copper
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 TABLETS

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

Each Tablet Contains: Amount
Per Tablet
% Daily
Value
Vitamin A (from Acetate and Beta Carotene) 4000 IU 80%
Vitamin C (Ascorbic Acid) 120 mg 200%
Vitamin D-3 (Cholecalciferol) 400 IU 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 (as Niacinamide) 20 mg 100%
Vitamin B-6 (Pyridoxine HCI) 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) 25mg 167%
Copper (Cupric Oxide) 2 mg 100%

Other Ingredients: Ascorbyl Palmitate, Citric Acid anhydrous, DL- alpha Tocopherol, Ethylcellulose, FD&C Blue #2 lake, FD&C Red #40 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.

Indications: To provide Vitamin and Mineral supplementation throughout pregnancy and during the postnatal period for both the lactating and nonlactating mother. It is also useful for improving nutritional status prior to conception.

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

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

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

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under six. KEEP THIS PRODUCT OUT OF REACH OF CHILDREN. In case of accidental overdose, call a physician or Poison Control Center immediately.

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

Manufactured in USA for: Patrin Pharma, Inc.
Skokie, IL 60076 800-936-3088
Rev 01.0313

Prenatal Vitamins Plus Low Iron 
prenatal with ferrous fum and folic acid tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:39328-106
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 mg
THIAMINE (THIAMINE ION) THIAMINE 1.84 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 3 mg
NIACIN (NIACIN) NIACIN 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) CALCIUM CARBONATE 200 mg
IRON (IRON) IRON 27 mg
ZINC (ZINC) ZINC 25 mg
COPPER (COPPER) COPPER 2 mg
Inactive Ingredients
Ingredient Name Strength
ASCORBYL PALMITATE  
ANHYDROUS CITRIC ACID  
.ALPHA.-TOCOPHEROL, DL-  
ETHYLCELLULOSES  
FD&C BLUE NO. 2  
FD&C RED NO. 40  
FD&C YELLOW NO. 6  
DEXTROSE  
ACACIA  
HYPROMELLOSES  
MAGNESIUM STEARATE  
STARCH, CORN  
MALTODEXTRIN  
METHYLCELLULOSE (100 MPA.S)  
CELLULOSE, MICROCRYSTALLINE  
MINERAL OIL  
GLYCERYL MONOSTEARATE  
POLYETHYLENE GLYCOLS  
SILICON DIOXIDE  
SORBIC ACID  
SOY PROTEIN  
STEARIC ACID  
SUCROSE  
TITANIUM DIOXIDE  
TRICALCIUM PHOSPHATE  
Product Characteristics
Color brown (Beige) Score no score
Shape OVAL (OVAL) Size 9mm
Flavor Imprint Code P;5
Contains         
Packaging
# Item Code Package Description
1 NDC:39328-106-10 100 TABLET (TABLET) in 1 BOTTLE, PLASTIC
2 NDC:39328-106-50 500 TABLET (TABLET) in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 04/01/2013
Labeler - Patrin Pharma, Inc. (806841677)
Registrant - Patrin Pharma, Inc. (806841677)
Establishment
Name Address ID/FEI Operations
Patrin Pharma, Inc. 806841677 MANUFACTURE(39328-106)
Revised: 06/2013
 
Patrin Pharma, Inc.



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