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Vitafol OB Caplet Package Insert

Updated:
Facts
Status:
Prescription (Rx) Boxed warning
Strength:
2700 IU, 70 mg, 400 IU, 30 IU, 1.6 mg, 1.8 mg, 18 mg, 2.5 mg, 1 mg, 12 mcg, 100 mg, 65 mg, 25 mg, 25 mg, 2 mg
Drug class:
Active ingredients:
Similar drugs:

Source: FDA drug labeling via NLM DailyMed · About this document

Prescribing information (package insert) - Vitafol OB Caplet

Rx only

COMPOSITION

Each Caplet contains:

VITAMINS AND MINERALS:
Vitamin A (as beta carotene)810mcg RAE
Vitamin C (as ascorbic acid)70mg
Vitamin D (as cholecalciferol)10mcg

Vitamin E

(as dl-alpha tocopheryl acetate)

13.5mg

Thiamin

(Vitamin B1 as thiamine mononitrate)

1.6mg
Riboflavin (Vitamin B2)1.8mg
Niacin (as niacinamide)18mg NE
Vitamin B6 (as pyridoxine hydrochloride)2.5mg
Folate (as folic acid)1700mg DFE
Vitamin B12 (as cyanocobalamin)12mcg
Calcium (as calcium carbonate)100mg
Iron (as ferrous fumarate)65mg
Magnesium (as magnesium oxide)25mg
Zinc (as zinc oxide)25mg
Copper (as copper oxide)2mg

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.

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).

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

*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

About this document

Source: FDA drug labeling via NLM DailyMed · View the label on DailyMed

Revision date stated in the text: December 2022

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Vitafol OB Caplet

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Boxed warning Yes – this drug has a boxed warning (also called a black box warning), the strongest warning of the FDA.
Drug class Calcium, Copper-containing Intrauterine Device, Nicotinic Acid, Vitamin A, Vitamin B12, Vitamin B6 Analog, Vitamin C, Vitamin D
Active ingredients Vitamin A 2700 IU, Ascorbic acid 70 mg, Vitamin D 400 IU, Alpha-tocopherol 30 IU, Thiamine mononitrate 1.6 mg, Riboflavin 1.8 mg, Niacin 18 mg, Pyridoxine hydrochloride 2.5 mg, Folic acid 1 mg, Cyanocobalamin 12 mcg, Calcium 100 mg, Iron 65 mg, Magnesium 25 mg, Zinc 25 mg, Copper 2 mg
Dosage form Tablet
Route Oral
Marketing status not in the current FDA NDC Directory
Company (applicant) Exeltis USA, Inc.
FDA approval UNAPPROVED DRUG OTHERUnapproved drug
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
2700 IU, 70 mg, 400 IU, 30 IU, 1.6 mg, 1.8 mg, 18 mg, 2.5 mg, 1 mg, 12 mcg, 100 mg, 65 mg, 25 mg, 25 mg, 2 mg – 3 in 1 carton NDC 0642-0079-03
2700 IU, 70 mg, 400 IU, 30 IU, 1.6 mg, 1.8 mg, 18 mg, 2.5 mg, 1 mg, 12 mcg, 100 mg, 65 mg, 25 mg, 25 mg, 2 mg – 100 in 1 carton NDC 0642-0079-12

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.