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Generic name: Vitamin A, Ascorbic Acid, Vitamin D, .Alpha.-Tocopherol, Thiamine Mononitrate, Riboflavin, Niacin, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium, Iron, Magnesium, Zinc, and Copper
Exeltis USA, Inc.
Dosage Form
N/A
Manufacturer
Exeltis USA, Inc.
This medication contains important usage instructions, warnings, and side effect information that you should review before use.
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 a Poison Control Center immediately.
Vitafol ®-OB is indicated to provide vitamin, mineral, supplementation prior to conception, throughout pregnancy, and during the postnatal period for the lactating and non-lactating mother.*
Before, during and after pregnancy, one caplet daily, or as directed by a physician.
Vitafol ®-OB is contraindicated in patients with hypersensitivity to any of its components or color additives.
Folic acid is contraindicated in patients with untreated and uncomplicated pernicious anemia, and in those with anaphylactic sensitivity to folic acid.
Iron therapy is contraindicated in patients with hemochromatosis and patients with iron storage disease or the potential for iron storage disease due to chronic hemolytic anemia (e.g., inherited anomalies of hemoglobin structure or synthesis and/or red cell enzyme deficiencies, etc.), pyridoxine responsive anemia, or cirrhosis of the liver.
Cyanocobalamin is contraindicated in patients with sensitivity to cobalt or to cyanocobalamin (vitamin B-12).
High doses of folic acid may result in decreased serum levels of the anticonvulsant drugs.
Vitamin D supplementation should not be given with large amounts of calcium in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones.
Zinc can inhibit the absorption of certain antibiotics; take at least 2 hours apart to minimize interactions.
Consult appropriate references for additional specific vitamin-drug interactions.
Adverse reactions have been reported with specific vitamins and minerals, but generally at doses substantially higher than those in Vitafol ®-OB. Allergic reactions have been reported with some forms of gum acacia to include respiratory problems and skin lesions.
Not for pediatric use.
Store at room temperature, approximately 15°-30°C (59°-86°F), avoid excessive heat and moisture.
Patients should be counseled to disclose all medical conditions, including use of all medications, vitamins and supplements, pregnancy, and breast-feeding.
Each Caplet contains:
| VITAMINS AND MINERALS: | ||
|---|---|---|
| Vitamin A (as beta carotene) | 810 |
mcg RAE |
| Vitamin C (as ascorbic acid) | 70 | mg |
| Vitamin D (as cholecalciferol) | 10 | mcg |
|
Vitamin E (as dl-alpha tocopheryl acetate) |
13.5 | mg |
|
Thiamin (Vitamin B1 as thiamine mononitrate) |
1.6 | mg |
| Riboflavin (Vitamin B2) | 1.8 | mg |
| Niacin (as niacinamide) | 18 | mg NE |
| Vitamin B6 (as pyridoxine hydrochloride) | 2.5 | mg |
| Folate (as folic acid) | 1700 | mg DFE |
| Vitamin B12 (as cyanocobalamin) | 12 | mcg |
| Calcium (as calcium carbonate) | 100 | mg |
| Iron (as ferrous fumarate) | 65 | mg |
| Magnesium (as magnesium oxide) | 25 | mg |
| Zinc (as zinc oxide) | 25 | mg |
| Copper (as copper oxide) | 2 | mg |
Other Ingredients: microcrystalline cellulose, croscarmellose sodium, silicon dioxide, maltodextrin, copovidone, stearic acid, hydroxypropyl methylcellulose, dicalcium phosphate, acacia gum, titanium dioxide, polydextrose, starch, magnesium stearate, triacetin, modified food starch, mannitol, vitamin E alcohol, polyethylene glycol, talc, FD&C Blue #1, FD&C Blue #2.
0642-0079-12
Vitafol
®-OB
Prenatal Supplement
10 X 10 UNIT DOSE PACK
100 CAPLETS
R x
[image: img_f12bd9e9-cb47-f62c-e053-2995a90a04b0]
Vitafol ®-OB is available as a light blue caplet, debossed EV0079. Available in Box of Unit-Dose pack of 100 (NDC 0642-0079-12) and as professional samples (0642-0079-03).
Photos of the product and/or packaging supplied by the manufacturer.
| *These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease. |
Rx
Disributed by:
Exeltis USA, Inc.
Florham Park, NJ 07932
1-877-324-9349
www.exeltisusa.com
©2022 All rights reserved. Exeltis USA, Inc.
U.S. PATENT NO. 6,814,983; 7,390,509
Vitafol ® is a trademark of Exeltis Healthcare S.L.
Rev. December 2022 0791201-02
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