Prenatal Plus

Generic Name: beta.-carotene, sodium acetate, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, ferrous fumarate, zinc oxide and cupric oxide
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 Plus

Each Tablet Contains:
VITAMINS:
Amount
per Tablet
Vitamin A (as 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 (Niacinamide) 20 mg
Vitamin B-6 (as Pyridoxine HCI) 10 mg
Folic Acid 1 mg
Vitamin B-12 (Cyanocobalamin) 12 mcg
MINERALS:
Calcium (Calcium Carbonate) 200 mg
Iron (Ferrous Fumarate) 27 mg
Zinc (Zinc Oxide) 25 mg
Copper (Cupric Oxide) 2 mg

Other Ingredients: croscarmellose sodium, FD&C Blue #2, FD&C Red #40, FD&C Yellow #5, FD&C Yellow #6, macrogol, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, silicon, starch, stearic acid, talc, titanium dioxide

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 a physician.

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of 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 CONTROLLED ROOM TEMPERATURE 15° to 30°C (59° to 86°F), AVOID EXCESS HEAT. Dispense in a well-closed light-resistant container, with a child resistant cap.

KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. DO NOT USE IF INNER SAFETY SEAL IS BROKEN OR MISSING.

Manufactured by: Nexgen Pharma, Colorado Springs, CO 80905

Distributed by: Seton Pharma, Manasquan, NJ 08736

Rev. 01-2014

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 13925-509-10

Prenatal
Plus

Vitamin and Mineral
Tablet

Multi-
Vitamin

Rx Only

100 Tablets

SETON
PHARMACEUTICALS

Prenatal Plus 
.beta.-carotene, sodium acetate, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, ferrous fumarate, zinc oxide and cupric oxide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:13925-509
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
.BETA.-CAROTENE (.BETA.-CAROTENE) .BETA.-CAROTENE 2000 [iU]
SODIUM ACETATE (ACETATE ION) SODIUM ACETATE ANHYDROUS 2000 [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 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) CALCIUM CARBONATE 200 mg
FERROUS FUMARATE (FERROUS CATION) FERROUS CATION 27 mg
ZINC OXIDE (ZINC CATION) ZINC CATION 25 mg
CUPRIC OXIDE (CUPRIC CATION) CUPRIC CATION 2 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM  
FD&C BLUE NO. 2  
FD&C RED NO. 40  
FD&C YELLOW NO. 5  
FD&C YELLOW NO. 6  
POLYETHYLENE GLYCOLS  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
POLYVINYL ALCOHOL  
SILICON  
STARCH, CORN  
STEARIC ACID  
TALC  
TITANIUM DIOXIDE  
Product Characteristics
Color YELLOW Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code G12
Contains         
Packaging
# Item Code Package Description
1 NDC:13925-509-10 100 TABLET (TABLET) in 1 BOTTLE
2 NDC:13925-509-50 500 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 03/07/2014
Labeler - Seton Pharmaceuticals LLC (828898002)
Revised: 03/2014
 
Seton Pharmaceuticals LLC



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