Se-natal 19 Tablet
FDA Label NDC 13925-116

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Seton Pharmaceuticals for the product Se-natal 19 (NDC 13925-116). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, description, other ingredients, indications, contraindications, warnings, boxed warning, precautions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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Other

Vitamins & Minerals with Folic Acid

Rx Only

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

MADE IN CANADA

Rev. 02/14

SETON PHARMACEUTICALS

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 (Vitamin B1)3 mg
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 Sodium25 mg

Other Ingredients

Acacia, Croscarmellose Sodium, Fumed Silica, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, 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.

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.

Boxed Warning

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 manifestations remain progressive.

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.

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

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