AV-VITE FB- folic acid, pyridoxine hydrochloride and cyanocobalamin tablet 
AvKARE, Inc.

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Av-VITE FB

Prescription Folic Acid-Containing Dietary Supplement

DESCRIPTION: The Av-VITE FB Tablet is an orally administered prescription dietary supplement for management of patients requiring increased folate levels.

The Av-VITE FB Tablet should be administered under the supervision of a licensed medical practitioner.

Supplement Facts
Serving Size: 1 Tablet
Amount per Serving% Daily Value
Vitamin B6 (as Pyridoxine HCl)25 mg            1250%
Folic Acid2.5 mg625%
Vitamin B(as Cyanocobalamin)1 mg  16667%

Other ingredients: Dibasic Calcium Phosphate Dihydrate, Microcrystalline Cellulose Ph101, Opadry II Pink 85F140140, (Polyvinyl Alcohol-Part Hydrolyzed, Titanium Dioxide, Macrogol/Peg, Talc, Carmine High Tint 50%, FD&C Blue #2/Indigo Carmine Al 3% - 5%), Croscarmellose Sodium, Opadry II Clear #Y-19-7483 (HPMC 2910/Hypromellose 6cP, Maltodextrin, HPMC 2910/Hypromellose 3cP, Macrogol/Peg 400, HPMC 2910/Hypromellose 50cP), Magnesium Stearate, NF.

Contains: FD&C Blue #2 and Carmine.

ALLERGY STATEMENTS:
This product has been manufactured in a facility that also manufactures products containing milk and soy. Individuals with allergic tendencies to these substances should use discretion.

Allergic reactions have been reported following the use of oral folate.

Mild transient diarrhea, polycythemia vera, itching, transitory exanthema and the feeling of swelling of the entire body have been associated with cobalamin.

Paresthesia, somnolence, nausea, and headaches have been reported with pyridoxine.

CONTRAINDICATIONS: This product is contraindicated in patients with a known hypersensitivity to any of the components contained in this product. .

INTERACTIONS: Drugs which may interact with folate include but are not limited to:

Drugs which may interact with folate include but are not limited to:
• First generation anticonvulsants (folate may reduce their effectiveness)
• Capecitabine (folate may enhance its toxicity)
• Fluorouracil (folate may enhance its toxicity)

Drugs that may interfere with folate metabolism include, but are not limited to:
• Dihydrofolate Reductase Inhibitors
• Fluoxetine
• Nonsteroidal Anti-inflammatory Drugs (NSAIDs)
• Sulfasalazine
• Warfarin

Drugs which may interfere with the absorption of folate from the gastrointestinal tract or decrease plasma levels include, but are not limited to:
• Cholestyramine
• Colestipol
• Oral Contraceptives
• Methylprednisolone
• Pancreatic Enzymes
• Pentamidine
• Smoking and Alcohol
• Sulfasalazine
• Metformin

Drugs which may interact with vitamin B6 include, but are not limited to:
• Levodopa (the action of levodopa may be antagonized by vitamin B6)

Drugs which may interact with vitamin B12 include but are not limited to:
• Antibiotics, cholestyramine, colchicines, colestipol, metformin, para-aminosalicylic, and potassium chloride (may decrease the absorption of vitamin B12).
• Nitrous oxide (can produce a functional vitamin B12 deficiency).

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 only B vitamins. Talk with your medical practitioner before using if pregnant or lactating.

DIRECTIONS FOR USE: One to two tablets daily or as directed by a licensed medical practitioner.

STORAGE: Store at room temperature 15° to 30°C (59° to 86°F). Protect from light and moisture. Dispense in a tight, light-resistant container.


HOW SUPPLIED: Av-VITE Tablets are supplied as round, coated, Pink colored tablets imprinted on one side with "V209", and are supplied in bottles of 90 tablets.  NDC 42291-149-90



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 AvKARE, Inc. at 1-855-361-3993 or FDA at 1-800-FDA-1088.

Manufactured for:
AvKARE, Inc.
Pulaski, TN  38478

Mfg. Rev. 06/15
AV Rev. 12/15 (P)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AvKARE
NDC
42291-149-90

Av-VITE FB

Prescription Folic Acid-Containing Dietary Supplement

90 Tablets
Must be used under the supervision of a physician.

Supplement Facts
Serving Size: 1 Tablet
Amount Per Serving% Daily Value
Vitamin B6
(as Pyridoxine HCl)
25 mg1250%
Folic Acid2.5 mg625%
Vitamin B12
(as Cyanocobalamin)
1 mg16667%

Other Ingredients: Dibasic Calcium Phosphate Dihydrate, Microcrystalline Cellulose Ph101,
Opadry II Pink 85F140140, (Polyvinyl Alcohol-Part Hydrolyzed, Titanium Dioxide, Macrogol/Peg, Talc, Carmine High Tint 50%, FD&C Blue #2/Indigo Carmine Al 3% - 5%), Croscarmellose Sodium, Opadry II Clear #Y-19-7483, (HPMC 2910/Hypromellose 6cP, Maltodextrin, HPMC 2910/Hypromellose 3cP, Macrogol/Peg 400, HPMC 2910/Hypromellose 50cP), Magnesium Stearate, NF.

Contains: FD&C Blue #2 and Carmine.

DESCRIPTION: Av-VITE FB is an orally administered prescription dietary supplement and should be administered
under the supervision of a licensed medical practitioner. See package insert for complete product information.

DIRECTION FOR USE: 1 or 2 tablets daily or as directed by a physician.

WARNING: Keep this and all medications out of the reach of children.

CAUTION: High levels of folic acid may, especially in older adults, hide signs of Vitamin B-12 deficiency (such as
pernicious anemia), a condition that can cause nerve damage.

STORAGE: Store at room temperature, 15ºC to 30ºC (59ºF - 86ºF).

Call your licensed medical practitioner about side effects. You may report side effects by calling AvKARE at
855-361-3993 or FDA at 1-800-FDA-1088.

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478

Mfg. Rev. 06-15          AV Rev. 04/16 (P)

label 1
label 1 back
AV-VITE FB 
folic acid, pyridoxine hydrochloride and cyanocobalamin tablet
Product Information
Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:42291-149(NDC:76439-364)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID2.5 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE25 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN1 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Calcium Phosphate, Dibasic, Dihydrate (UNII: O7TSZ97GEP)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Fd&c Blue No. 2 (UNII: L06K8R7DQK)  
TALC (UNII: 7SEV7J4R1U)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:42291-149-9090 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Dietary Supplement01/06/201611/15/2018
Supplement Facts
Serving Size : Serving per Container :
Amount Per Serving% Daily Value
color
scoring1
shape
size (solid drugs)8 mm
imprint
Labeler - AvKARE, Inc. (796560394)

Revised: 4/2016
 
AvKARE, Inc.