Se-Natal 19

Generic Name: vitamins,minerals and folic acid
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.

Se-Natal 19 Tablets

Vitamins & Minerals with Folic Acid

Rx Only

Se-Natal 19 Description

Se-Natal 19 provides oil soluble vitamins, water-soluble vitamins and minerals.

Each tablet contains:
Vitamin A (as beta carotene) 1000 IU
Vitamin C (ascorbic acid) 100 mg
Vitamin D (as cholecalciferol) 400 IU
Vitamin E (as dl-alpha tocopheryl acetate) 30 IU
Thiamine Mononitrate (Vitamin B1) 3mg
Riboflavin (Vitamin B2) 3 mg
Niacin (as niacinamide) 15 mg
Vitamin B6 (as pyridoxine HCI) 20 mg
Folate (folic acid) 1 mg
Vitamin B12 (as cyanocobalamin) 12 mcg
Pantothenic Acid (as calcium pantothenate) 7 mg
Calcium (as calcium carbonate) 200 mg
Iron (as ferrous fumarate) 29 mg
Zinc (as zinc oxide) 20 mg
Docusate Sodium 25 mg

OTHER INGREDIENTS

Carnauba Wax, Corn Starch, Dicalcium Phosphate, Fumed Silica, Gum Arabic, Hydroxy Propyl Methyl Cellulose, Maltodextrin, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Propylene Glycol, Sodium Benzoate, Stearic Acid, Talc, and Titanium Dioxide.

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INDICATIONS

Se-Natal 19 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 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 0.1 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestation 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 tablets for oral administration are supplied as white, coated, oblong tablets debossed "TL019," packaged in bottles of 100 tablets.

NDC 13925-116-01.

STORAGE

Store at room temperature, USP. Protect from moisture and excessive heat. Avoid freezing.

PHARMACIST

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

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

All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product may be administered only under a physician's supervision. There are no implied or explicit claims on therapeutic equivalence.

Reserved for Professional Recommendation.

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

Rx Only

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

Rev.11.07.2011

SETON PHARMACEUTICALS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 13925-116-01

Se-Natal 19
Tablets

Vitamins and Minerals with Folic Acid

100 Tablets

Rx Only

SETON
PHARMACEUTICALS

Se-Natal 19 
vitamins,minerals and folic acid tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:13925-116
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETA CAROTENE (BETA CAROTENE) BETA CAROTENE 1000 [iU]
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 100 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU]
.ALPHA.-TOCOPHEROL ACETATE, DL- (ALPHA-TOCOPHEROL) ALPHA-TOCOPHEROL 30 mg
THIAMINE MONONITRATE (THIAMINE) THIAMINE 3 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 3 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 15 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE 20 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 12 ug
CALCIUM PANTOTHENATE (PANTOTHENIC ACID) PANTOTHENIC ACID 7 mg
CALCIUM CARBONATE (CALCIUM) CALCIUM 200 mg
FERROUS FUMARATE (IRON) IRON 29 mg
ZINC OXIDE (ZINC) ZINC 20 mg
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 25 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX  
STARCH, CORN  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE  
SILICON DIOXIDE  
ACACIA  
HYPROMELLOSES  
MALTODEXTRIN  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
POLYETHYLENE GLYCOL  
PROPYLENE GLYCOL  
SODIUM BENZOATE  
STEARIC ACID  
TALC  
TITANIUM DIOXIDE  
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code TL019
Contains         
Packaging
# Item Code Package Description
1 NDC:13925-116-01 100 TABLET (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)
Establishment
Name Address ID/FEI Operations
Cispharma, Inc. 833171445 MANUFACTURE
Revised: 07/2011
 
Seton Pharmaceuticals



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