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

Vitafol OB by

Drug Labeling and Warnings

Vitafol OB by is a Prescription medication manufactured, distributed, or labeled by Exeltis USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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).

BOXED WARNING

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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.

PRECAUTIONS

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.

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

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	Item Code (Source)	NDC: 0642-0079
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Vitamin A (UNII: 81G40H8B0T) (Vitamin A - UNII:81G40H8B0T)	Vitamin A	2700 [iU]
Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R)	Ascorbic Acid	70 mg
Vitamin D (UNII: 9VU1KI44GP) (Cholecalciferol - UNII:1C6V77QF41)	Vitamin D	400 [iU]
.Alpha.-Tocopherol (UNII: H4N855PNZ1) (.Alpha.-Tocopherol - UNII:H4N855PNZ1)	.Alpha.-Tocopherol	30 [iU]
Thiamine Mononitrate (UNII: 8K0I04919X) (Thiamine Ion - UNII:4ABT0J945J)	Thiamine	1.6 mg
Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR)	Riboflavin	1.8 mg
Niacin (UNII: 2679MF687A) (Niacin - UNII:2679MF687A)	Niacin	18 mg
Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z)	Pyridoxine Hydrochloride	2.5 mg
Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8)	Folic Acid	1 mg
Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204)	Cyanocobalamin	12 ug
Calcium (UNII: SY7Q814VUP) (Calcium - UNII:SY7Q814VUP)	Calcium	100 mg
Iron (UNII: E1UOL152H7) (Iron - UNII:E1UOL152H7)	Iron	65 mg
Magnesium (UNII: I38ZP9992A) (Magnesium - UNII:I38ZP9992A)	Magnesium	25 mg
Zinc (UNII: J41CSQ7QDS) (Zinc - UNII:J41CSQ7QDS)	Zinc	25 mg
Copper (UNII: 789U1901C5) (Copper - UNII:789U1901C5)	Copper	2 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	BLUE	Score	no score
Shape	OVAL	Size	19mm
Flavor		Imprint Code	EV0079
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0642-0079-08	4 in 1 CARTON; Type 0: Not a Combination Product	12/02/2002
2	NDC: 0642-0079-12	100 in 1 CARTON; Type 0: Not a Combination Product	12/02/2002

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		12/02/2002

Labeler - Exeltis USA, Inc. (071170534)