PreNatal 19
PreNatal 19
FULL PRESCRIBING INFORMATION: CONTENTS*
- PRENATAL 19 DESCRIPTION
- INDICATIONS
- PRENATAL 19 CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- PRENATAL 19 DOSAGE AND ADMINISTRATION
- HOW SUPPLIED
- PHARMACIST
- PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label
FULL PRESCRIBING INFORMATION
PRENATAL 19 DESCRIPTION
PreNatal 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) | 3 mg |
| Riboflavin (Vitamin B2) | 3 mg |
| Niacin (as niacinamide) | 15 mg |
| Vitamin B6 (as pyridoxine HCl) | 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, Fumed Silica, Gum Arabic, Hydroxy Propyl Methyl Cellulose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Stearic Acid, Talc, and Titanium Dioxide.
INDICATIONS
PreNatal 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. PreNatal 19 tablets are also useful in improving the nutritional status of women prior to conception.
PRENATAL 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.
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.
PRENATAL 19 DOSAGE AND ADMINISTRATION
One tablet daily, or as directed by a physician.
HOW SUPPLIED
PreNatal 19 tablets for oral administration are supplied as white, coated, oblong tablets debossed "C41," packaged in bottles of 100 tablets.
NDC 42937-706-10.
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.
Distributed by:
Nationwide Laboratories LLC
Iselin NJ 08830
Lot No.: Exp. Date: Rev. 12/12
PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label
Nationwide Laboratories LLC
NDC 42937-706-10
PreNatal 19
Tablets
Vitamins and Minerals
with Folic Acid
Rx only
100 Tablets
PreNatal 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, COATED
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