FDA Label for Vitafol Ob Caplet
View Indications, Usage & Precautions
Vitafol Ob Caplet Product Label
The following document was submitted to the FDA by the labeler of this product Exeltis Usa, 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.
Composition
Each Caplet contains:
| VITAMINS AND MINERALS: | |||
|---|---|---|---|
| Vitamin A (as beta carotene) | 2700 | IU | |
| Vitamin C (as ascorbic acid) | 70 | mg | |
| Vitamin D3 (as cholecalciferol) | 400 | IU | |
| Vitamin E (as dl-alpha tocopheryl acetate) | 30 | IU | |
| Thiamine mononitrate (Vitamin B1) | 1.6 | mg | |
| Riboflavin (Vitamin B2) | 1.8 | mg | |
| Niacin (as niacinamide) | 18 | mg | |
| Vitamin B6 (as pyridoxine hydrochloride) | 2.5 | mg | |
| Folic acid | 1.0 | mg | |
| 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, Gelatin, Sodium Croscarmellose, Stearic Acid, Gum Acacia, Silicon Dioxide, Magnesium Stearate, Modified Food Starch, Sucrose, Silicon Dioxide, Maize Starch, Dicalcium Phosphate, Sodium Ascorbate, Tocopherol Concentrate, Medium Chain Triglycerides, Sorbic Acid, Tricalcium Phosphate, dl-Alpha-Tocopherol. Coating: Hypromellose, Titanium Dioxide, Polydextrose, Triacetin, Hydroxypropyl Cellulose, FD&C Blue #1 / Aluminum Lake, Polyethylene Glycol, FD&C Blue #2 / Aluminum Lake, FD&C Yellow #10 Aluminum Lake.
Contains: Soy
Indications And Usage
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.
Contraindications
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).
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 a Poison Control Center immediately.
Warnings/Precautions
Vitamin D supplementation should be used with caution in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones. High doses of vitamin D can lead to elevated levels of calcium that reside in the blood and soft tissues. Bone pain, high blood pressure, formation of kidney stones, renal failure, and increased risk of heart disease can occur.
Prolonged use of iron salts may produce iron storage disease.
Folic acid, especially in doses above 0.1 mg daily, may obscure pernicious anemia, in that hematologic remission may occur while neurological manifestations remain progressive.
The use of folic acid doses above 1 mg daily may precipitate or exacerbate the neurological damage of vitamin B12 deficiency.
Avoid Overdosage. Keep out of the reach of children.
Drug Interactions
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.
Information For Patients
Patients should be counseled to disclose all medical conditions, including use of all medications, vitamins and supplements, pregnancy, and breast-feeding.
Pediatric Use
Not for pediatric use.
Adverse Reactions
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.
Dosage And Administration
Before, during and after pregnancy, one caplet daily, or as directed by a physician.
How Supplied
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).
Storage And Handling
Store at room temperature, approximately 15°-30°C (59°-86°F), avoid excessive heat and moisture.
Other
Rx
Disributed by:
Exeltis USA, Inc.
Florham Park, NJ 07932
1-877-324-9349
www.exeltisusa.com
©2015 Exeltis USA, Inc.
U.S. PATENT NO. 6,814,983; 7,390,509
Vitafol® is a trademark of Exeltis USA, Inc.
REV. October 2015
Principal Display Panel - 100 Caplet Carton
0642-0079-12
Vitafol®-OB
Prenatal Supplement
10 X 10 UNIT DOSE PACK
100 CAPLETS
Rx
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