PNV TABS 29-1- .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium pantothenate, calcium carbonate, iron, potassium iodide, magnesium oxide, zinc oxide, and cupric oxide tablet

PNV Tabs 29-1 by

Drug Labeling and Warnings

PNV Tabs 29-1 by is a Other medication manufactured, distributed, or labeled by Virtus Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HEALTH CLAIM

69543-267-90
Rx

•   Prenatal/Postnatal
  Prescription Folic Acid-Containing Dietary Supplement

DESCRIPTION

PNV Tabs 29-1 is a prescription oral dietary supplement and should be administered under the supervision of a licensed medical practitioner.

Supplement Facts Table Serving Size: 1 Tablet
	Amount Per Serving	% Daily Value* for Pregnant & Lactating Women
* The % Daily Value tells you how much a nutrient in a serving of food contributes to a daily diet. 2,000 calories a day is used for general nutrition advice.
Vitamin A (beta carotene)	600 mcg RAE	46 %
Vitamin C (ascorbic acid)	120 mg	100 %
Vitamin D (Vitamin D3 as cholecalciferol)	10 mcg (400 IU)	67 %
Vitamin E (dl-alpha-tocopheryl acetate)	27 mg	142 %
Thiamin (Vitamin B1 as thiamine mononitrate)	3 mg	214 %
Riboflavin (Vitamin B2)	3 mg	188 %
Niacin (niacinamide)	20 mg NE	111 %
Vitamin B6 (pyridoxine HCl)	3 mg	150 %
Folate	1667 mcg DFE; (1 mg folic acid)	278 %
Vitamin B12 (cyanocobalamin)	8 mcg	286 %
Biotin	30 mcg	86 %
Pantothenic Acid (calcium pantothenate)	7 mg	100 %
Calcium (calcium carbonate)	200 mg	15 %
Iron (carbonyl iron)	29 mg	107 %
Iodine (potassium iodide)	150 mcg	52 %
Magnesium (magnesium oxide)	100 mg	25 %
Zinc (zinc oxide)	15 mg	115 %
Copper (cupric oxide)	3 mg	231 %

Other Ingredients: Microcrystalline Cellulose, Stearic Acid, Coating (Hypromellose, Polydextrose, Titanium Dioxide, Polyethylene Glycol), Croscarmellose Sodium, Silicon Dioxide, Magnesium Stearate.

ALLERGY STATEMENT

This product has been manufactured in a facility that also manufactures products containing tree nuts, peanuts, fish, egg, wheat, milk, soy and shellfish. Individuals with allergic tendencies to these substances should use discretion.

PHARMACOLOGY

Adequate Folate in healthful diets may reduce a woman's risk of having a child with a brain or spinal cord defect.1

SIDE EFFECTS2

Side effects are uncommon with folic acid, thiamine, riboflavin, pyridoxine, iron, and copper.

Gastrointestinal side effects including anorexia, nausea, abdominal distention, flatulence, and bitter taste are rarely seen with folic acid and pyridoxine. Gastrointestinal side effects due to iron include nausea, constipation, anorexia, heartburn, vomiting, and diarrhea.

Hypersensitivity reactions due to folic, thiamine, or pyridoxine have been seen rarely.

PATIENT INFORMATION

This product is a dietary management prescription folate supplement to be used only under licensed medical supervision. Consult a medical practitioner before use with medications.

KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN.

INTERACTIONS2

Folic acid has major interactions with fluorouracil and its prodrugs, for example capecitabine. Use of this product with patients who are taking fluorouracil drugs should be undertaken only with extreme caution under the direction of a licensed medical practitioner.

Folic acid also interacts moderately with antiepileptic drugs, monoamines (e.g. levodopa, serotonin) and drugs that interfere with homocysteine metabolism.

Drugs known to interfere with folic acid absorption from the intestine include cholestyramine, colestipol, and cyclosporine.

Drugs which may interact moderately with vitamin B12 include arsenic and chloramphenicol.

Carbonyl iron has major interactions with abacavir/dolutegravir and lamivudine, dimercaprol and dolutegravir.

Vitamin C (ascorbic acid) interacts moderately with amphetamines and the antineoplastic drug bortezomib.

CONTRAINDICATIONS

This product is contraindicated in patients with a known hypersensitivity to any of the components contained in this product. This product is contraindicated for individuals with conditions for which any of the ingredients are contraindicated.

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 immediately3.

DIRECTIONS FOR USE

One tablet daily with or without food or as prescribed by a licensed medical practitioner, regardless of lactation status.

REFERENCES

• 1. 21 CFR §101.79(d)(1)(ii)
• 2. All side effects and drug information was obtained from www.drugs.com
• 3. 21 CFR 101.17(e)(1)

PREGNANCY and NURSING MOTHERS

Use of PNV Tabs 29-1 with products containing folic acid is not recommended, as this will result in folic acid intake that exceeds the daily upper limit.

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. Notice: Contact with moisture may produce surface discoloration or erosion.

HOW SUPPLIED

PNV Tabs 29-1 are supplied as oval, white tablets debossed on one side with "V267" dispensed in child-resistant bottles of 90 tablets.

Call your medical practitioner about side effects. You may report side effects by calling Virtus at 1-888-848-3593.

Rx

Manufactured for:
Virtus Pharmaceuticals, LLC.
Langhorne, PA 19047

MADE IN USA

Rev. 09/2018

PRINCIPAL DISPLAY PANEL - 90 Tablet Bottle Label

VIRTUS®
PHARMACEUTICALS

69543-267-90

PNV Tabs 29-1

PRENATAL/POSTNATAL

Prescription Folic Acid-Containing
Dietary Supplement

Rx

90 Tablets

Made in the USA

INGREDIENTS AND APPEARANCE

PNV TABS 29-1 
.beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium pantothenate, calcium carbonate, iron, potassium iodide, magnesium oxide, zinc oxide, and cupric oxide tablet

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:69543-267
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 hydrochloride	3 mg
Folic acid (UNII: 935E97BOY8) (Folic acid - UNII:935E97BOY8)	Folic acid	1 mg
Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204)	Cyanocobalamin	8 ug
Biotin (UNII: 6SO6U10H04) (Biotin - UNII:6SO6U10H04)	Biotin	30 ug
Calcium pantothenate (UNII: 568ET80C3D) (Pantothenic acid - UNII:19F5HK2737, Calcium cation - UNII:2M83C4R6ZB)	Pantothenic acid	7 mg
Calcium carbonate (UNII: H0G9379FGK) (Calcium cation - UNII:2M83C4R6ZB, Carbonate Ion - UNII:7UJQ5OPE7D)	Calcium carbonate	200 mg
Iron (UNII: E1UOL152H7) (Iron - UNII:E1UOL152H7)	Iron	29 mg
Potassium iodide (UNII: 1C4QK22F9J) (Iodide ion - UNII:09G4I6V86Q)	Potassium iodide	150 ug
Magnesium oxide (UNII: 3A3U0GI71G) (Magnesium cation - UNII:T6V3LHY838)	Magnesium oxide	100 mg
Zinc oxide (UNII: SOI2LOH54Z) (Zinc oxide - UNII:SOI2LOH54Z)	Zinc oxide	15 mg
Cupric oxide (UNII: V1XJQ704R4) (Cupric cation - UNII:8CBV67279L)	Cupric cation	3 mg

Inactive Ingredients
Ingredient Name	Strength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
STEARIC ACID (UNII: 4ELV7Z65AP)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
POLYDEXTROSE (UNII: VH2XOU12IE)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:69543-267-90	90 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Dietary Supplement		07/16/2015

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

Labeler - Virtus Pharmaceuticals (079659493)