FDA Label for Prenatal Plus Vitamins
View Indications, Usage & Precautions
Prenatal Plus Vitamins Product Label
The following document was submitted to the FDA by the labeler of this product Remedyrepack Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Description
| Supplement Facts | ||
|---|---|---|
| Serving Size: 1 Tablet | Amount per Serving | % Daily Value
Daily Value is for Pregnant and Lactating Women |
| Vitamin A | 1200 mcg | 92% |
| (Acetate and Beta Carotene) | RAE | |
| Vitamin C (Ascorbic Acid) | 120 mg | 100% |
| Vitamin D-3 (Cholecalciferol) | 10 mcg | 67% |
| Vitamin E (dl-α Tocopheryl Acetate) | 10 mg | 53% |
| Vitamin B-1 (Thiamine Mononitrate) | 1.84 mg | 131% |
| Vitamin B-2 (Riboflavin) | 3 mg | 188% |
| Niacin (Niacinamide) | 20 mg | 111% |
| Vitamin B-6 (Pyridoxine HCl) | 10 mg | 500% |
| Folic Acid | 1667 mcg | 278% |
| DFE (1 mg) | ||
| Vitamin B-12 (Cyanocobalamin) | 12 mcg | 429% |
| Calcium (Calcium Carbonate) | 200 mg | 15% |
| Iron (Ferrous Fumarate) | 27 mg | 100% |
| Zinc (Zinc Oxide) | 25 mg | 192% |
| Copper(Cupric Oxide) | 2 mg | 154% |
Other Ingredients:Hypromellose, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Polyethylene Glycol, Stearic Acid, Titanium Dioxide, FD&C Blue #2 lake, FD&C Red #40 lake, FD&C Yellow #6 lake
Prenatal Plus Vitamins is a prescription folic acid containing dietary vitamin and mineral supplement for women before, during and after pregnancy.
Directions
Use before, during and after pregnancy under the supervision of a medical professional. One tablet daily or as prescribed.
Caution
Folic acid may partially correct the hematological damage due to Vitamin B-12 deficiency of pernicious anemia while the associated neurological damage progresses.
Warning
Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under six. Keep this product out of the reach of children. In case of accidental overdose, call a Physician or Poison Control Center immediately.
Storage
Store at room temperature, USP. Protect from light and moisture.Dispense in a tight, light-resistant container. Contact with moisture may discolor or erode tablets.
Other
Repackaged and Distributed By:
Remedy Repack, Inc.
625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
Package Label.Principal Display Panel
DRUG: Prenatal Plus Vitamins
GENERIC: prenatal with ferrous fumarate and folic acid
DOSAGE: TABLET
ADMINSTRATION: ORAL
NDC: 70518-4258-0
COLOR: brown
SHAPE: OVAL
SCORE: No score
SIZE: 9 mm
IMPRINT: P;5
PACKAGING: 100 in 1 BOTTLE, PLASTIC
ACTIVE INGREDIENT(S):
- Vitamin A Acetate 924ug in 1
- Beta Carotene 276ug in 1
- Ascorbic Acid 120mg in 1
- Cholecalciferol 10ug in 1
- .Alpha.-TocopheroL Acetate, DL- 10mg in 1
- Thiamine Mononitrate 1.84mg in 1
- Riboflavin 3mg in 1
- Niacinamide 20mg in 1
- Pyridoxine Hydrochloride 10mg in 1
- Folic Acid 1667ug in 1
- Cyanocobalamin 12ug in 1
- Calcium Carbonate 200mg in 1
- Ferrous Fumarate 27mg in 1
- Zinc Oxide 25mg in 1
- Cupric Oxide 2mg in 1
- Hypromellose, Unspecified
- Magnesium Stearate
- Maltodextrin
- Microcrystalline Cellulose
- Polyethylene Glycol 400
- Stearic Acid
- Titanium Dioxide
- FD&C Blue NO. 2
- FD&C Red NO. 40
- FD&C Yellow NO. 6
INACTIVE INGREDIENT(S):
* Please review the disclaimer below.
