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 
Exeltis USA, Inc.

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.

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Vitafol®-OB
Prenatal Supplement

Rx only

COMPOSITION

Each Caplet contains:

VITAMINS AND MINERALS:
Vitamin A (as beta carotene)2700IU
Vitamin C (as ascorbic acid)70mg
Vitamin D3 (as cholecalciferol)400IU
Vitamin E (as dl-alpha tocopheryl acetate)30IU
Thiamine mononitrate (Vitamin B1)1.6mg
Riboflavin (Vitamin B2)1.8mg
Niacin (as niacinamide)18mg
Vitamin B6 (as pyridoxine hydrochloride)2.5mg
Folic acid1.0mg
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, 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).

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

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

PRINCIPAL DISPLAY PANEL - 100 Caplet Carton
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 TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0642-0079
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Vitamin A (UNII: 81G40H8B0T) (Vitamin A - UNII:81G40H8B0T) Vitamin A2700 [iU]
Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid70 mg
Vitamin D (UNII: 9VU1KI44GP) (Cholecalciferol - UNII:1C6V77QF41) Vitamin D400 [iU]
.Alpha.-Tocopherol (UNII: H4N855PNZ1) (.Alpha.-Tocopherol - UNII:H4N855PNZ1) .Alpha.-Tocopherol30 [iU]
Thiamine Mononitrate (UNII: 8K0I04919X) (Thiamine Ion - UNII:4ABT0J945J) Thiamine1.6 mg
Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR) Riboflavin1.8 mg
Niacin (UNII: 2679MF687A) (Niacin - UNII:2679MF687A) Niacin18 mg
Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride2.5 mg
Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid1 mg
Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204) Cyanocobalamin12 ug
Calcium (UNII: SY7Q814VUP) (Calcium - UNII:SY7Q814VUP) Calcium100 mg
Iron (UNII: E1UOL152H7) (Iron - UNII:E1UOL152H7) Iron65 mg
Magnesium (UNII: I38ZP9992A) (Magnesium - UNII:I38ZP9992A) Magnesium25 mg
Zinc (UNII: J41CSQ7QDS) (Zinc - UNII:J41CSQ7QDS) Zinc25 mg
Copper (UNII: 789U1901C5) (Copper - UNII:789U1901C5) Copper2 mg
Inactive Ingredients
Ingredient NameStrength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
Stearic Acid (UNII: 4ELV7Z65AP)  
Croscarmellose Sodium (UNII: M28OL1HH48)  
Gelatin, Unspecified (UNII: 2G86QN327L)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Modified Corn Starch (1-Octenyl Succinic Anhydride) (UNII: 461P5CJN6T)  
Sucrose (UNII: C151H8M554)  
Starch, Corn (UNII: O8232NY3SJ)  
Sodium Ascorbate (UNII: S033EH8359)  
Tocopherol (UNII: R0ZB2556P8)  
Magnesium Stearate (UNII: 70097M6I30)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Acacia (UNII: 5C5403N26O)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
Sorbic Acid (UNII: X045WJ989B)  
Tricalcium Phosphate (UNII: K4C08XP666)  
.Alpha.-Tocopherol, DL- (UNII: 7QWA1RIO01)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
Polydextrose (UNII: VH2XOU12IE)  
Triacetin (UNII: XHX3C3X673)  
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
FD&C Blue No. 1 (UNII: H3R47K3TBD)  
Aluminum Oxide (UNII: LMI26O6933)  
FD&C Blue No. 2 (UNII: L06K8R7DQK)  
D&C Yellow No. 10 (UNII: 35SW5USQ3G)  
Product Characteristics
ColorBLUEScoreno score
ShapeOVALSize19mm
FlavorImprint Code EV0079
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0642-0079-084 in 1 CARTON; Type 0: Not a Combination Product12/02/2002
2NDC:0642-0079-12100 in 1 CARTON; Type 0: Not a Combination Product12/02/2002
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other12/02/2002
Labeler - Exeltis USA, Inc. (071170534)

Revised: 1/2021
Document Id: f649f499-dd07-4572-9348-58e4df40b872
Set id: 22828f24-600d-4aa6-9b3a-cf8c991f9a97
Version: 5
Effective Time: 20210119
 
Exeltis USA, Inc.