V-Natal (Page 2 of 2)


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Folate is a broad term that includes folic acid and all reduced forms including l-methylfolate and folinic acid. V-Natal Tabs does not contain l-methylfolate or folinic acid but these warnings are included as general folate information.

Drugs which interact with vitamin B12 :

  • Antibiotics, cholestyramine, colchicines, colestipol, metformin, para-aminosalicylic acid, and potassium chloride may decrease the absorption of vitamin B12 .
  • Nitrous oxide can produce a functional vitamin B12 deficiency.

Drugs which interact with vitamin B6 :

  • Vitamin B6 should not be given to patients receiving the drug levodopa because the action of levodopa is antagonized by vitamin B6 . However, vitamin B6 may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa.
  • Isoniazid can produce a vitamin B6 deficiency.

Drugs which may interact with vitamin D3 :

  • Certain thiazide diuretics, such as hydrochlorothiazide, as well as antacids, bile acid sequestrants (such as cholestyramine), mineral oil, orlistat, olestra, cimetidine, and anticonvulsant medications may reduce the absorption or increase the catabolism of vitamin D.
  • Vitamin D supplementation should not be given with calcium in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones.

Drugs which may interact with zinc:

  • Concomitant administration of zinc supplements and certain antibiotics, specifically tetracyclines and quinolones, may decrease absorption of the antibiotic and potentially reduce its efficacy.

PREGNANCY and NURSING MOTHERS

V-Natal Tabs is intended for use as a prescription PRENATAL folate before, during, and after pregnancy regardless of lactation status.

Adverse Reactions to V-Natal

Allergic sensitization has been reported following both oral and parental administration of folic acid, and may possibly occur with other forms of folate. Paresthesia, somnolence, nausea and headaches have been reported with vitamin B6 . Mild transient diarrhea, polycythemia vera, itching, transitory exanthema and the feeling of swelling of the entire body have been associated with vitamin B12 .

DOSAGE AND ADMINISTRATION

One tablet daily or as directed by a licensed medical practitioner.

STORAGE

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

HOW SUPPLIED

V-Natal Tabs is supplied as oval, pink film-coated tablets debossed on one side with “VTAB”, dispensed in bottles of 90 tablets.

Product Code: 76439-226 -90

*This product is a PRENATAL/POSTNATAL prescription folate that contains folate in an amount higher than 0.1 mg, and has an increased risk associated with masking of vitamin B12 deficiency and must be administered under a physician’s supervision (AUG 3 1973 FR 20750). This product requires licensed medical supervision and a Rx status as required by pedigree reporting requirements.

KEEP THIS OUT OF REACH OF CHILDREN.

All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.

Call your medical practitioner about side effects. You may report side effects by calling (813) 283- 1344.

Rx

Manufactured for:
Virtus Pharmaceuticals, LLC
Tampa, Florida 33619

MADE IN CANADA

Rev. 6/2012

PRINCIPAL DISPLAY PANEL — 90 Tablet Bottle Label

VIRTUS
PHARMACEUTICALS

Product Code: 76439-226 -90
V-Natal Tabs PRENATAL / POSTNATAL
Prescription Folate

Rx 90 Tablets

PRINCIPAL DISPLAY PANEL -- 90 Tablet Bottle Label
(click image for full-size original)
V-NATAL
folic acid, pyridoxine, calcium formate, calcium carbonate, sodium ascorbate, cholecalciferol, acetate ion, thiamine mononitrate, riboflavin, niacinamide, cyanocobalamin, ferrous bisglycinate, potassium iodide, zinc oxide, and choline bitartrate tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76439-226
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Folic Acid (Folic Acid) Folic Acid 1000 ug
pyridoxine (pyridoxine) pyridoxine 50 mg
Calcium formate (Calcium cation) Calcium formate 155 mg
Calcium carbonate (Calcium cation) Calcium carbonate 45 mg
sodium ascorbate (ascorbic acid) sodium ascorbate 120 mg
cholecalciferol (cholecalciferol) cholecalciferol 450 [iU]
acetate ion (acetate ion) acetate ion 30 [iU]
thiamine mononitrate (thiamine ion) thiamine mononitrate 3 mg
riboflavin (riboflavin) riboflavin 3 mg
niacinamide (niacinamide) niacinamide 20 mg
cyanocobalamin (cyanocobalamin) cyanocobalamin 10 ug
ferrous bisglycinate (ferrous cation) ferrous bisglycinate 32 mg
potassium iodide (iodide ion) potassium iodide 100 ug
zinc oxide (zinc oxide) zinc oxide 10 mg
choline bitartrate (choline) choline bitartrate 55 mg
Inactive Ingredients
Ingredient Name Strength
Acacia
croscarmellose sodium
crospovidone
1,2-dibromo-3-chloropropane
Citric Acid Monohydrate
Magnesium Stearate
Cellulose, Microcrystalline
Fd&C Red No. 40
hypromelloses
Polyethylene Glycols
polyvinyl alcohol
Sucralose
Talc
Titanium Dioxide
povidone k30
Silicon Dioxide
Stearic acid
Potassium Citrate Anhydrous
Product Characteristics
Color PINK Score no score
Shape OVAL Size 23mm
Flavor Imprint Code VTAB
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76439-226-90 90 TABLET, COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 07/12/2012
Labeler — Virtus Pharmaceuticals (969483143)

Revised: 08/2012 Virtus Pharmaceuticals

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