Vitafol One 9 mg/1
Prenatal Supplement with DHA · CAPSULE, GELATIN COATED · Exeltis USA, Inc.
Vitafol One is a prescription prenatal supplement in capsule form that contains DHA and vitamin C to support maternal and fetal health during pregnancy. It is taken by mouth and is designed to provide nutritional support for pregnant women.
Key Facts
- Brand Name
- Vitafol One
- Generic Name
- Prenatal Supplement with DHA
- NDC Code (Product)
0642-0070- Manufacturer
- Exeltis USA, Inc.
- Strength
- 9 mg/1
- Dosage Form
- CAPSULE, GELATIN COATED
- Route
- ORAL
- Marketing Status
- Drug Class
- Vitamin C [EPC]; Copper-containing Intrauterine Device [EPC]
- Marketing Start
- 06/13/2011
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
USAGE: Vitafol ® One 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, including individuals with known allergies to fish.*
Dosage & Administration
DOSAGE AND ADMINISTRATION: Before, during and after pregnancy, take one softgel capsule by mouth daily, or as directed by a physician.
Warnings
WARNINGS/PRECAUTIONS: Vitafol ® One should be used with caution in patients with known sensitivity or allergy to soy. 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. Iodine should be used with caution in patients with an overactive thyroid. 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. Consumption of more than 3 grams of omega-3 fatty acids per day from all sources may lead to excessive bleeding. Supplemental intake of omega-3 fatty acids such as DHA exceeding 2 grams per day is not recom…
Contraindications
CONTRAINDICATIONS: Vitafol ® One 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).
Drug Interactions
Drug Interactions: Medications for an overactive thyroid (anti-thyroid drugs) used in conjunction with iodine supplementation may lead to hypothyroidism. Medications for hypertension used in conjunction with iodine supplementation may increase potassium. High doses of folic acid may result in decreased serum levels of the anticonvulsant drugs; carbamazepine, fosphenytoin, phenytoin, phenobarbitol, valproic acid. Folic acid may decrease a patient's response to methotrexate. 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; taken at least 2 hours apart to minimize interactions. Consult appropriate references for additional specific vitamin drug interactions.
Adverse Reactions
ADVERSE REACTIONS: Adverse reactions have been reported with specific vitamins and minerals, but generally at doses substantially higher than those in Vitafol ® One. However, allergic and idiosyncratic reactions are possible at any dose. Reported adverse events include skin ailments, gastrointestinal complaints, glucose abnormalities, and visual problems. You should call your doctor for medical advice about serious adverse events. To report a serious adverse event or obtain product information, contact 1-877-324-9349.
Frequently Asked Questions
What is Vitafol One used for?
Vitafol One is a prescription prenatal supplement in capsule form that contains DHA and vitamin C to support maternal and fetal health during pregnancy. It is taken by mouth and is designed to provide nutritional support for pregnant women.
Is Vitafol One a controlled substance?
Vitafol One is not classified as a controlled substance by the DEA.
What is the generic name for Vitafol One?
The generic name for Vitafol One is Prenatal Supplement with DHA. There are no other listed brand versions of Prenatal Supplement with DHA.
What is the NDC code for Vitafol One 9 mg/1?
The NDC (National Drug Code) for Vitafol One 9 mg/1 is 0642-0070, listed by Exeltis USA, Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)