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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, Copper, and Doconexent
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 reach of children. In case of accidental overdose, call a doctor or a Poison Control Center immediately.
Vitafol ®-OB+DHA is indicated to provide vitamin, mineral and omega-3 fatty acid supplementation prior to conception, throughout pregnancy, and during the postnatal period for the lactating and non-lactating mother.*
Vitafol ®-OB+DHA does not contain fish, fish oils, fish proteins or fish byproducts.
Before, during and after pregnancy, take one caplet and one soft-gel capsule by mouth daily, or as directed by a physician.
Vitafol ®-OB+DHA 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+DHA. Allergic reactions have been reported with some forms of gum acacia to include respiratory problems and skin lesions.
Contact your doctor for medical advice about serious adverse events. To report a serious adverse event or obtain
product information, contact 1-877-324-9349.
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 Vitafol ®-OB caplet contains:
| 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 mcg 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 |
| Each DHA softgel capsule contains: | |
|
Docosahexaenoic acid (DHA) (from natural algal oil) |
250 mg |
0642-0076-30
Vitafol ®-OB+DHA
Prenatal Supplement with DHA
SUGAR, LACTOSE, GLUTEN AND IODINE FREE
New
Smaller DHA Softgel
DOES NOT CONTAIN
FISH OIL
R
X
Unit Dose Pack
30 Caplets and 30 Softgel Capsules
U.S. Patented
[image: img_f12cd7fc-d4ed-b4bb-e053-2995a90ae4a6]
Vitafol ®-OB+DHA is available as a light blue caplet debossed EV0079 and one amber-colored DHA softgel capsule. Available in Box of Unit-Dose pack of 30 (5 child resistant blister cards of 6 caplets and 6 softgel capsules each) (0642-0076-30) and as professional samples (0642-0076-03).
Photos of the product and/or packaging supplied by the manufacturer.
Prenatal Supplement with DHA
Rx
Other ingredients: gelatin (bovine), gylcerin, microcrystalline cellulose, croscarmellose sodium, silicon dioxide, maltodextrin, copovidone, stearic acid, water, 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. Contains: Soy.
| *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
Distributed by:
Exeltis USA, Inc.
Florham Park, NJ 07932
1-877-324-9349
www.exeltisusa.com
©2024 Exeltis USA, Inc.
U.S. Patent No. 6,814,983; 7,390,509
Vitafol
® is a trademark of Exeltis USA, Inc.
Rev. July 2024
0763001-04
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