PRENATAL 19- folic 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
Nationwide Laboratories, LLC
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.
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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 |
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.
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 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.
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.
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.
| PRENATAL 19
folic 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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| Labeler - Nationwide Laboratories, LLC (078366153) |
| Registrant - Nationwide Laboratories, LLC (078366153) |