Vitafol-OB+DHA Prescribing Information

Package insert / product label
Generic name: prenatal supplement with DHA
Dosage form: caplets, capsules
Drug classes: Iron products, Vitamin and mineral combinations

Medically reviewed by Drugs.com. Last updated on Dec 1, 2022.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. Read further information about unapproved drugs.

0642-0076-30

Prenatal Supplement with DHA

Rx

COMPOSITION

Each Vitafol ®-OB caplet contains:

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.

Indications and Usage for Vitafol-OB+DHA

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.

Contraindications

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).

WARNINGS/PRECAUTIONS

Vitamin D supplementation should be used with caution in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathryroidism 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. 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 recommended.

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+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.

Vitafol-OB+DHA Dosage and Administration

Before, during and after pregnancy, one caplet and one soft-gel capsule daily, or as directed by a physician.

How is Vitafol-OB+DHA Supplied

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).

Store at room temperature, approximately 15°-30°C (59°-86°F), avoid excessive heat and moisture.

Rx

Distributed by:

Exeltis USA, Inc.

Florham Park, NJ 07932



1-877-324-9349

www.exeltisusa.com

©2021 Exeltis USA, Inc.

U.S. Patent No. 6,814,983; 7,390,509

Vitafol ® is a trademark of Exeltis USA, Inc.

Rev. May 2021

0763001-02

PRINCIPAL DISPLAY PANEL - Kit Carton

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

Medical Disclaimer