PreNatal 19
PreNatal 19
FULL PRESCRIBING INFORMATION: CONTENTS*
- PRENATAL 19 DESCRIPTION
- INDICATIONS
- PRENATAL 19 CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- PRENATAL 19 DOSAGE AND ADMINISTRATION
- HOW SUPPLIED
- PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label
FULL PRESCRIBING INFORMATION
PRENATAL 19 DESCRIPTION
PreNatal 19 chewable tablets are round, debossed "C43". These tablets provide oil-soluble vitamins and minerals.
| Each tablet has the following active ingredient: | |
| Folate (folic acid) | 1 mg |
| Each tablet also contains the following ingredients for nutritional supplement: | |
| Vitamin A (as beta carotene) | 1000 IU |
| Vitamin C (as ascorbic acid) | 100 mg |
| Vitamin D (as cholecalciferol) | 400 IU |
| Vitamin E (as dl-alpha-tocopheryl acetate) | 30 IU |
| Thiamine (Vitamin B1) | |
| (thiamine mononitrate) | 3 mg |
| Riboflavin (Vitamin B2) | 3 mg |
| Niacin (as niacinamide) | 15 mg |
| Vitamin B6 (as pyridoxine HCl) | 20 mg |
| Vitamin B12 (as cyanocobalamine) | 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 |
OTHER INGREDIENTS:
Flavors, magnesium stearate, maltodextrin, mannitol, silicon dioxide, stearic acid, sucralose and sucrose.
INDICATIONS
PreNatal 19 chewable tablets are indicated for use in improving the nutritional status of women throughout pregnancy and in postnatal period for both lactating and non-lactating mothers. PreNatal 19 chewable 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 the 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 hematological 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 chewable tablets for oral administration are supplied as multi-color-speckled,round tablets debossed "C43", packaged in bottles of 100 tablets.
PHARMACIST
Dispense in a tight, light–resistant container as defined in the USP/NF with child-resistant closure.
STORAGE
Store at 20°-25°C (68°-77°F) [see USP controlled room temperature]. Protect from moisture and excessive heat. Avoid freezing.
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.
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 42937-707-10
PreNatal 19
Chewable Tablets
A Prescription Prenatal Vitamin
with other Vitamins and Minerals
for Nutritional Supplementation
Rx only
100 Tablets
PreNatal 19FOLIC ACID, .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, CALCIUM PANTOTHENATE, CALCIUM CARBONATE, FERROUS FUMARATE, and ZINC OXIDE TABLET, CHEWABLE
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