Prenatal Plus
Generic Name: vitamin a acetate, .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, ferrous fumarate, zinc oxide and cupric oxide
Dosage Form: tablet, film coated
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.
Prenatal Plus
Vitamin and Mineral Tablet
Multi-Vitamin
Rx Only
Prenatal Plus Description
Each Tablet Contains:
VITAMINS: Amount per Tablet
Vitamin A (from Acetate and Beta Carotene) ............................. 4000 IU
Vitamin C (Ascorbic Acid) ........................................................... 120 mg
Vitamin D-3 (Cholecalciferol) ....................................................... 400 IU
Vitamin E (dl- Alpha Tocopheryl Acetate) ...................................... 22 IU
Thiamine (Vitamin B-1) (from Thiamine Mononitrate) ................. 1.84 mg
Riboflavin (Vitamin B-2) .................................................................. 3 mg
Niacin (as Niacinamide) ................................................................ 20 mg
Vitamin B-6 (Pyridoxine HCl) ......................................................... 10 mg
Folic Acid ......................................................................................... 1 mg
Vitamin B-12 (Cyanocobalamin) ................................................... 12 mcg
MINERALS: Amount per Tablet
Calcium (as Calcium Carbonate) ................................................. 200 mg
Iron (from Ferrous Fumarate) ........................................................ 27 mg
Zinc (from Zinc Oxide) ................................................................... 25 mg
Copper (from Cupric Oxide) ........................................................... 2 mg
Other ingredients: croscarmellose sodium, FD&C Blue #2, FD&C Red #40, FD&C Yellow # 5, FD&C Yellow # 6, macrogol, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, silicon, starch, stearic acid, talc, titanium dioxide
Indications and Usage for Prenatal Plus
To provide Vitamin and Mineral supplementation throughout pregnancy and during the postnatal period for both the lactating and non-lactating mother. It is also useful for improving nutritional status prior to conception.
Warnings
| WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under age 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 may partially correct the hematological damage due to Vitamin B12 deficiency of pernicious anemia, while the associated neurological damage progesses.
Prenatal Plus Dosage and Administration
As a dietary adjunct before, during and after pregnancy, take one tablet daily with a meal, or as directed by a physician.
How is Prenatal Plus Supplied
Bottles of 100: NDC 65162-668-10
Bottles of 500: NDC 65162-668-50
Storage
STORE AT CONTROLLED ROOM TEMPERATURE 15º to 30ºC (59º to 86ºF), AVOID EXCESS HEAT.
Dispense in a well closed light-resistant container, with a child resistant cap.
KEEP THIS AND ALL MEDICATION OUR OF THE REACH OF CHILDREN.
DO NOT USE IF INNER SAFETY SEAL IS BROKEN OR MISSING.
Manufactured by:
Nexgen Pharma
Colorado Springs, CO 80905
Distributed by:
Amneal Pharmaceuticals
Glasgow, KY 42141
Rev. 09-2012
| Prenatal Plus vitamin a acetate, .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, ferrous fumarate, zinc oxide, cupric oxide tablet, film coated | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Labeler - Amneal Pharmaceuticals, LLC (123797875) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Nexgen Pharma, Inc. | 806784679 | ANALYSIS(65162-668), MANUFACTURE(65162-668) | |
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