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Vitafol-OB

Generic Name: vitamin a, ascorbic acid, vitamin d, .alpha.-tocopherol, thiamine mononitrate, riboflavin, niacin, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium, iron, magnesium, zinc and copper
Dosage Form: tablet

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

Vitafol®-OB
Prenatal Supplement

Rx only

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 for Vitafol-OB

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.

Vitafol-OB Dosage and Administration

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

How is Vitafol-OB 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).

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

Rx only

Manufactured for
EVERETT LABORATORIES, INC.
Chatham, NJ 07928

1-877-324-9349

U.S. PATENT NO. 6,814,983; 7,390,509

Vitafol® is a trademark of Everett Laboratories, Inc.

REV. 07/13

PRINCIPAL DISPLAY PANEL - 100 Caplet Carton

NDC 0642-0079-12

Vitafol®-OB

Prenatal Supplement

10 X 10 UNIT DOSE PACK
100 CAPLETS

RX only

VITAFOL OB   CAPLET
vitamin a, ascorbic acid, vitamin d, .alpha.-tocopherol, thiamine mononitrate, riboflavin, niacin, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium, iron, magnesium, zinc, and copper tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0642-0079
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Vitamin A (Vitamin A) Vitamin A 2700 [iU]
Ascorbic Acid (Ascorbic Acid) Ascorbic Acid 70 mg
Vitamin D (Cholecalciferol) Vitamin D 400 [iU]
.Alpha.-Tocopherol (.Alpha.-Tocopherol) .Alpha.-Tocopherol 30 [iU]
Thiamine Mononitrate (Thiamine Ion) Thiamine 1.6 mg
Riboflavin (Riboflavin) Riboflavin 1.8 mg
Niacin (Niacin) Niacin 18 mg
Pyridoxine Hydrochloride (Pyridoxine) Pyridoxine Hydrochloride 2.5 mg
Folic Acid (Folic Acid) Folic Acid 1 mg
Cyanocobalamin (Cyanocobalamin) Cyanocobalamin 12 ug
Calcium (Calcium) Calcium 100 mg
Iron (Iron) Iron 65 mg
Magnesium (Magnesium) Magnesium 25 mg
Zinc (Zinc) Zinc 25 mg
Copper (Copper) Copper 2 mg
Inactive Ingredients
Ingredient Name Strength
Cellulose, Microcrystalline  
Stearic Acid  
Croscarmellose Sodium  
Gelatin  
Calcium Phosphate, Dibasic, Anhydrous  
Silicon Dioxide  
Modified Corn Starch (1-Octenyl Succinic Anhydride)  
Sucrose  
Starch, Corn  
Sodium Ascorbate  
Tocopherol  
Magnesium Stearate  
Titanium Dioxide  
Acacia  
Polyethylene Glycols  
Medium-Chain Triglycerides  
Sorbic Acid  
Tricalcium Phosphate  
.Alpha.-Tocopherol, DL-  
Hypromelloses  
Polydextrose  
Triacetin  
Hydroxypropyl Cellulose (Type H)  
FD&C Blue No. 1  
Aluminum Oxide  
FD&C Blue No. 2  
D&C Yellow No. 10  
Product Characteristics
Color BLUE Score no score
Shape OVAL Size 19mm
Flavor Imprint Code EV0079
Contains         
Packaging
# Item Code Package Description
1 NDC:0642-0079-08 4 TABLET in 1 CARTON
2 NDC:0642-0079-12 100 TABLET in 1 CARTON
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 12/02/2002
Labeler - Everett Laboratories, Inc. (071170534)
Revised: 09/2014
 
Everett Laboratories, Inc.
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