Av-VITE

Name: Av-VITE

References

  1. Wu A, Chanarin I, Levi AJ. Macrocytosis of chronic alcoholism. The Lancet. 1974;1:829-31.
  2. Hallert C, Tobiasson P, Walan A. Serum folate determinations in tracing adult coeliacs. Scand J Gastroenterol. 1981; 16:263-67.
  3. De-Regil LM, Fernández-Gaxiola AC, Dowswell T, et al. Effects and safety of periconceptional folate supplementation for preventing birth defects. Cochrane Database Syst Rev. 2010 Oct 6;(10):CD007950. doi: 10.1002/14651858.CD007950.pub2.
  4. Federal Register Notice of April 9, 1971 (36 FR 6843).
  5. The Federal Register Notice of August 2, 1973 (38 FR 20750).
  6. The Federal Register Notice of October 17, 1980 (45 FR 69044).
  7. The Federal Register Notice of August 2, 1973 (38 FR 20750).
  8. Letter Regarding Dietary Supplement Health Claim for Folic Acid, Vitamin B6, and Vitamin B12 and Vascular Disease (Docket No. 99P-3029). November 28, 2000.
  9. The Federal Register Notice of March 5, 1996 (61 FR 8760).
  10. Letter Regarding Dietary Supplement Health Claim for Folic Acid With Respect to Neural Tube Defects (Docket No. 91N-100H). October 10, 2000.
  11. Code of Federal Regulations Title 21 Section 172.345.
  12. Code of Federal Regulations Title 21 Section 101.9(j)(8).
  13. Safrin S, Lee BL, Sande MA. Adjunctive folinic acid with trimethoprim-sulfamethoxazole for Pneumocystis carinii pneumonia in AIDS patients is associated with an increased risk of therapeutic failure and death. J Infect Dis. 1994 Oct;170(4):912-7.

INDICATIONS AND USAGE: The Av-VITE FB Tablets is indicated for the distinct nutritional requirements of patients in need of dietary supplementation as determined by a licensed medical practitioner.

PATIENT INFORMATION: The Av-VITE FB Tablets is a prescription dietary supplement to be used only under licensed medical supervision.

PREGNANCY and NURSING MOTHERS: The Av-VITE FB Tablets is not intended for use as a prenatal/postnatal multivitamin for lactating and nonlactating mothers. This product contains B vitamins in reduced form. Talk with your medical practitioner before using if pregnant or lactating.

DOSAGE AND ADMINISTRATION: One to two tablets daily or as directed by a licensed medical practitioner.

HOW SUPPLIED: The Av-VITE FB Tablets are round coated pink tablets debossed on one side with “V209”, and are supplied in bottles of 90 tablets

* This product is a prescription-folate with or without other dietary ingredients that - due to increased folate levels (AUG 2 1973 FR 20750), requires an Rx on the label because of increased risk associated with masking of B12 deficiency (pernicious anemia). Based on our assessment of the risk of obscuring pernicious anemia, this product requires licensed medical supervision, an Rx status, and a National Drug Code (NDC) - or similar product code, as required by pedigree reporting requirements and supply-chain control as well as - in some cases, for insurance-reimbursement applications.
NDC: *42291-150-90

This product may - under certain circumstances, be dispensed through a certified mail-order program so long as there is record of prescription AND confirmation that the patient is under licensed medical supervision. This product is not an Orange Book (OB) rated product, therefore all prescriptions using this product shall be pursuant to state statutes as applicable.

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.

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 1-855-361-3993.

Rx

Manufactured for:
AvKARE, Inc.
Pulaski, TN  38478

Mfg. Rev. 12/13
AV 10/15 (P)

Package label.principal display panel

AvKARE
NDC 42291-150-90

Av-VITE FB

Prescription Vitamin Bg-Containing Dietary Supplement

90 Tablets        Rx Only

Supplement Facts
Serving Size: 1 Tablet
Amount Per Serving % Daily Value
Vitamin B6
(as Pyridoxine HCl)
25 mg 1250%
Folacine (Folic Acid) 2.5 mg 625%
Vitamin B12
(as Cyanocobalamin)
1 mg 1667%

Other Ingredients: Microcrystalline Cellulose, Silica, Croscarmellose Sodium, Magnesium Stearate (Vegetable Source), Stearic Acid, Titanium Dioxide, Carmine, FD&C Red #2, Hypromellose, Carnauba Wax.

DESCRIPTION: Av-VITE FB is an orally administered prescription dietary supplement and should be
administered under the supervision of a licensed medical practitioner.

DOSAGE AND ADMINISTRATION: One to two tablets daily or as prescribed by a licensed medical practitioner.

PRECAUTION: Folic Acid may obscure pernicious anemia in that the peripheral blood picture may revert to
normal while neurological manifestations remain progressive. Allergic sensitization has been reported following both oral and parenteral administration of Folic Acid.

Store at controlled room temperature 15º-30ºC (59º-86ºF). [See USP].
Protect from light and moisture. Dispense in a tight, light-resistant container.

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

Call your licensed medical practitioner about side effects. You may report side effects by calling 855-361-3993.

HOW SUPPLIED: Supplied as pink tablet imprinted with "V209" dispensed in bottles of 90 tablets.

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478

Mfg. Rev. 09/2014          AV 10/15 (P)

Av-VITE FB  
folic acid, pyridoxine hydrochloride and cyanocobalamin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:42291-150(NDC:76439-209)
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FOLIC ACID (FOLIC ACID) FOLIC ACID 2.5 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 25 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 1 mg
Inactive Ingredients
Ingredient Name Strength
TRISODIUM CITRATE DIHYDRATE  
CITRIC ACID MONOHYDRATE  
CELLULOSE, MICROCRYSTALLINE  
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS  
CROSCARMELLOSE SODIUM  
HYDROXYPROPYL CELLULOSE (TYPE H)  
STEARIC ACID  
MAGNESIUM STEARATE  
SILICON DIOXIDE  
POWDERED CELLULOSE  
TITANIUM DIOXIDE  
POLYDEXTROSE  
TALC  
MALTODEXTRIN  
C10-18 TRIGLYCERIDES  
PIGMENT RED 48  
POLYETHYLENE GLYCOLS  
MICROCRYSTALLINE WAX  
Product Characteristics
Color PINK Score no score
Shape ROUND Size 10mm
Flavor Imprint Code V209
Contains     
Packaging
# Item Code Package Description
1 NDC:42291-150-90 90 TABLET in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 11/05/2015
Labeler - AvKARE, Inc. (796560394)
Revised: 11/2015   AvKARE, Inc.
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