PRETAB- .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, ferrous fumarate, potassium iodide, and zinc oxide tablet

PreTAB by

Drug Labeling and Warnings

PreTAB by is a Other medication manufactured, distributed, or labeled by Virtus Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HEALTH CLAIM

69543-259-10

Rx

PRENATAL / POSTNATAL

Prescription Multivitamin Dietary Supplement

DESCRIPTION

PreTAB Tablet (PNV-Ca with 29 mg Fe; 1 mg FA) is an orally administered prescription prenatal/postnatal dietary supplement and should be administered under the supervision of a health care provider.

Supplement Facts
Serving Size: 1 Tablet
	Amount Per Serving	% Daily Value for Pregnant and Lactating Women
Vitamin A (as beta carotene)	4000 IU	50%
Vitamin C (ascorbic acid)	120 mg	200%
Vitamin D (Vitamin D3 as cholecalciferol)	400 IU	100%
Vitamin E (as dl-alpha tocopheryl acetate)	30 IU	100%
Thiamin (Vitamin B1 thiamine mononitrate)	3 mg	176%
Riboflavin (Vitamin B2)	3 mg	150%
Niacin (as niacinamide)	20 mg	100%
Vitamin B6 (pyridoxine HCl)	3 mg	120%
Folic Acid	1 mg	125%
Vitamin B12 (cyanocobalamin)	8 mcg	100%
Calcium (as calcium carbonate)	200 mg	15%
Iron (as ferrous fumarate)	29 mg	161%
Iodine (potassium iodide)	150 mcg	100%
Zinc (as zinc oxide)	15 mg	100%

Other ingredients: Microcrystalline Cellulose, Croscarmellose Sodium, Magnesium Stearate, Silicon Dioxide , Hypromellose, Polydextrose, Titanium Dioxide, Talc, Maltodextrin, Medium Chain Triglycerides, FD&C Red #40, FD&C Yellow #6 and FD&C Blue #1.

SIDE EFFECTS

Folic acid. Most adults do not experience side effects when taking oral folic acid. Allergic reactions have been reported, and mild side effects, which usually occur with relatively large doses of folic acid supplements, include nausea, insomnia, decreased appetite, flatulence, abdominal distension, difficulty concentrating and some bitter taste in the tongue. If you experience any of these, talk with your health care provider.

Thiamin (Vitamin B1) usually has no side effects. A very serious allergic reaction is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Riboflavin (Vitamin B2) usually has no side effects, but large amounts may cause urine to be more yellow than normal.

Pyridoxine (Vitamin B6) usually has no side effects, but rarely numbness and tingling, sleepiness, nausea, and headaches have been reported with pyridoxine. Allergy and hypersensitivity reactions are rare.

Cyanocobalamin (Vitamin B12) usually has no side effects. However, mild transient diarrhea, polycythemia vera, itching, transitory exanthema, and the feeling of swelling of the entire body, muscle cramps, weakness, irregular heartbeat have been seen rarely.

Ascorbic Acid (Vitamin C) has no side effects in many people, but diarrhea, nausea, vomiting, abdominal cramps or heartburn have occurred.

PATIENT INFORMATION

This product is a prescription prenatal multivitamin dietary supplement to be used only as prescribed by your health care provider. Your health care provider may choose to prescribe this product along with other medications. Your healthcare provider may prescribe PreTAB for other conditions.

INDICATIONS AND USAGE

PreTAB prescription multivitamin tablets are used for the nutritional support of pregnant and lactating women.

WARNINGS

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

INTERACTIONS

If you are taking any prescription or over-the-counter medicines, or herbal supplements talk with your health care provider and/or pharmacist before taking them together with this product because they may interact with folate.

CONTRAINDICATIONS

This product is contraindicated for persons with a known hypersensitivity to any of the ingredients and for persons with conditions for which any of the ingredients are contraindicated.

WARNINGS

Overdose can be quite dangerous to epileptics as folate has been seen to cause seizures. Allergic reactions have also been reported in a few cases.

CAUTION

Patients with a history of bipolar illness, as mood elevation is possible following co-administration of folate with antidepressant therapy.

PREGNANCY and NURSING MOTHERS

PreTAB tablet (PNV-Ca with 29 mg Fe; 1 mg FA) is intended for use as a prescription PRENATAL folate before, during, and after pregnancy.

DIRECTIONS FOR USE

One tablet daily or as directed by a healthcare provider.

STORAGE

Store at Controlled Room Temperature 15°to 30°C (59°to 86°F). Protect from light and moisture. Dispense in a tight, light-resistant container.

HOW SUPPLIED

PreTAB tablet (PNV-Ca with 29 mg Fe; 1 mg FA) is supplied as oblong, pink tablets, Imprinted "V259", dispensed in bottles of 100 tablets.

69543-259-10

Keep This Out Of Reach Of Children.

Call your healthcare provider about side effects. You may report side effects by calling Virtus at 1-888-848-3593 or FDA at 1-800-FDA-1088.

Rx

Manufactured for:
Virtus Pharmaceuticals, LLC
Tampa, Florida 33619
1-888-848-3593
MADE IN USA

Rev. 08/2016

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

VIRTUS
PHARMACEUTICALS

69543-259-10

PreTAB Tablet
(PNV-Ca with 29 mg Fe; 1 mg FA)

PRENATAL / POSTNATAL

Prescription Multivitamin
Dietary Supplement

Rx
100 Tablets
Made in USA

INGREDIENTS AND APPEARANCE

PRETAB 
.beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, ferrous fumarate, potassium iodide, and zinc oxide tablet

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:69543-259
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
.BETA.-CAROTENE (UNII: 01YAE03M7J) (.BETA.-CAROTENE - UNII:01YAE03M7J)	.BETA.-CAROTENE	4000 [iU]
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	120 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	400 [iU]
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01)	.ALPHA.-TOCOPHEROL, DL-	30 [iU]
THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J)	THIAMINE	3 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR)	RIBOFLAVIN	3 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	20 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE	3 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	8 ug
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	200 mg
FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	29 mg
POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q)	IODIDE ION	150 ug
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	15 mg

Inactive Ingredients
Ingredient Name	Strength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
POLYDEXTROSE (UNII: VH2XOU12IE)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TALC (UNII: 7SEV7J4R1U)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:69543-259-10	100 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
DIETARY SUPPLEMENT		07/15/2015

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
scoring	1
shape
size (solid drugs)	19 mm
imprint

Labeler - Virtus Pharmaceuticals (079659493)