Se-Natal 19

Generic Name: vitamins and minerals
Dosage Form: tablet, chewable

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.

Se-Natal 19 Chewable Tablets

A Prescription Prenatal Vitamin with other Vitamins and Minerals for Nutritional Supplementation

Rx Only

Se-Natal 19 Description

Se·Natal 19 Chewable tablets are round, debossed "TL015." These tablets provide oil-soluble vitamins, water-soluble vitamins and minerals.

Each tablet has the following active ingredient:
Folate
(folic acid) 1 mg
Each tablet also contains the following ingredients for nutritional supplement:
Vitamin A
(as beta carotene)
1000 IU
Vitamin C
(calcium ascorbate)
100 mg
Vitamin D3
(as cholecalciferol)
400 IU
Vitamin E
(as dl-alpha tocopheryl acetate)
30 IU
Thiamine
(Vitamin B1) (thiamine mononitrate)
3mg
Riboflavin
(Vitamin B2)
3 mg
Niacinamide
(Vitamin B3)
15 mg
Vitamin B6
(as pyridoxine HCI)
20 mg
Vitamin B12
(as cyanocobalamin)
12 mcg
Pantothenic Acid
(as D Calcium Pantothenate)
7 mg
Calcium
(as calcium carbonate)
200 mg
Iron
(as ferrous fumarate)
29 mg
Zinc
(as zinc oxide)
20 mg

INACTIVE INGREDIENTS

Acacia, Fumed Silica, Magnesium Stearate, Natural Orange Flavour, Orange Juice Powder, Stearic Acid, Stevia, Sucrose.

INDICATIONS

Se-Natal 19 Chewable Tablets are indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and non-lactating mothers. Se-Natal 19 Chewable Tablets are also useful in improving the nutritional status of women prior to conception.

Contraindications

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

Warnings

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.

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 in doses above 0.8 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive.

Se-Natal 19 Dosage and Administration

One tablet daily, or as directed by a physician.

How is Se-Natal 19 Supplied

Se-Natal 19 Chewable Tablets for oral administration are supplied as multi-color-speckled, round tablets debossed "TL015," packaged in bottles of 100 tablets.

NDC 13925-117-01

STORAGE

Store at 20°-25°C (68°-77°F [see USP controlled room temperature]. Protect from moisture and excessive heat. Avoid freezing.

PHARMACIST

Dispense in a tight, light-resistant container as defined in the USP/INF with child-resistant closure.

Call your doctor about side effects. You may report side effects to FDA at 1-800-FDA-1088.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

Rx Only

Manufactured For:
Seton Pharmaceuticals
Manasquan, NJ 08736
1-800-510-3401
MADE IN CANADA

08/13

SETON PHARMACEUTICALS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 13925-117-01

Se-Natal 19 Chewable
Tablets

A Prescription Prenatal Vitamin with other Vitamins and Minerals for Nutritional Supplementation

Rx Only

100 Tablets

SETON
PHARMACEUTICALS

Se-Natal 19 CHEWABLE 
vitamins and minerals tablet, chewable
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:13925-117
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
BETA CAROTENE (BETA CAROTENE) BETA CAROTENE 1000 [iU]
CALCIUM ASCORBATE (ASCORBIC ACID) ASCORBIC ACID 100 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU]
.ALPHA.-TOCOPHEROL ACETATE, DL- (.ALPHA.-TOCOPHEROL, DL-) .ALPHA.-TOCOPHEROL, DL- 30 [iU]
THIAMINE MONONITRATE (THIAMINE ION) THIAMINE 3 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 3 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 15 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE 20 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 12 ug
CALCIUM PANTOTHENATE (PANTOTHENIC ACID) PANTOTHENIC ACID 7 mg
CALCIUM CARBONATE (CALCIUM CATION) CALCIUM CATION 200 mg
FERROUS FUMARATE (FERROUS CATION) FERROUS CATION 29 mg
ZINC OXIDE (ZINC CATION) ZINC CATION 20 mg
Inactive Ingredients
Ingredient Name Strength
ACACIA  
SILICON DIOXIDE  
MAGNESIUM STEARATE  
ORANGE JUICE  
STEARIC ACID  
STEVIA REBAUDIUNA LEAF  
SUCROSE  
Product Characteristics
Color BROWN Score no score
Shape ROUND Size 12mm
Flavor ORANGE Imprint Code TL015
Contains         
Packaging
# Item Code Package Description
1 NDC:13925-117-01 100 TABLET, CHEWABLE (TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 07/01/2009
Labeler - Seton Pharmaceuticals (828898002)
Revised: 08/2013
 
Seton Pharmaceuticals



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