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Se-Natal 19

Seton Pharmaceuticals

Se-Natal 19 Tablets


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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.

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.

SE-NATAL 19 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 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

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 1000 [iU]
ASCORBIC ACID ASCORBIC ACID 100 mg
CHOLECALCIFEROL CHOLECALCIFEROL 400 [iU]
.ALPHA.-TOCOPHEROL ACETATE, DL- .ALPHA.-TOCOPHEROL, DL- 30 mg
THIAMINE MONONITRATE THIAMINE ION 3 mg
RIBOFLAVIN RIBOFLAVIN 3 mg
NIACINAMIDE 15 mg
PYRIDOXINE HYDROCHLORIDE PYRIDOXINE 20 mg
FOLIC ACID FOLIC ACID 1 mg
Cyanocobalamin CYANOCOBALAMIN 12 ug
CALCIUM PANTOTHENATE PANTOTHENIC ACID 7 mg
CALCIUM CARBONATE 200 mg
FERROUS FUMARATE FERROUS CATION 29 mg
Zinc Oxide Zinc oxide 20 mg
DOCUSATE SODIUM DOCUSATE 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 Size Imprint Code Shape
WHITE 19 mm TL019 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13925-116-01 100 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2009-07-01


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