Se-Natal 19: Package Insert and Label Information

SE-NATAL 19- beta carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium pantothenate, calcium carbonate, ferrous fumarate, zinc oxide and docusate sodium tablet
Royal Pharmaceuticals

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.

Vitamins & Minerals with Folic Acid

Rx Only

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.

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.

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 68791-116-01.

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:
Royal Pharmaceuticals
Manasquan, NJ 08736
1-800-510-3401

Rev.03.01.2011

ROYAL PHARMACEUTICALS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68791-116 -01

Se-Natal 19 Tablets

Vitamins and Minerals with Folic Acid

100 Tablets

Rx Only

ROYAL PHARMACEUTICALS

PRINCIPAL DISPLAY PANEL -- 100 tablets
(click image for full-size original)
SE-NATAL 19
vitamins,minerals and folic acid tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68791-116
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 Multilevel Packaging
1 NDC:68791-116-01 100 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 07/01/2009
Labeler — Royal Pharmaceuticals (078374385)
Establishment
Name Address ID/FEI Operations
Viva, Inc. 253288898 MANUFACTURE
Establishment
Name Address ID/FEI Operations
Rainbow Gold 800695152 REPACK

Revised: 03/2012 Royal Pharmaceuticals

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