FOLIKA-V- ascorbic acid, cholecalciferol, thiamine, vitamin b6. folate, vitamin b12, nahd, coenzyme q10 tablet 
Innovida Phamaceutique Corporation

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Innovida FOLIKA-V

Dosage and Administration

Usual adult dose is 1 tablet once or twice daily or as prescribed by a licensed medical practitioner. If you are pregnant or nursing, ask a healthcare professional.

Warnings

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Folika-V tablets should only be used under the direction and supervision of a licensed medical practitioner. Use with caution in patients that may have a medical condition, are pregnant, lactating, trying to conceive, under the age of 18, or taking medications.

Pregnancy and Lactation

Folika-V is not intended for use in pregnant or lactating patients.

HOW SUPPLIED HEALTH CLAIM:

Folika-V tablets are supplied as oval shaped biconvex tablet, very light yellow, with yellow-orange speckles in a child-resistant bottle of 30ct. (71800-004-30*)


Dispensed by Prescription†
*Innovida Pharmaceutique Corporation does not represent these product codes to be National Drug Codes (NDC). Product codes are formatted according to standard industry practice, to meet the formatting requirement by pedigree reporting and supply-chain control including pharmacies.


† This product is a prescription-folate with or without other dietary ingredients that – due to increased folate levels increased risk associated with masking of B12 deficiency (pernicious anemia) requires administration under the care of a licensed medical practitioner (61 FR 8760).1-3 The most appropriate way to ensure pedigree reporting consistent with these regulatory guidelines and safety monitoring is to dispense this product only by prescription (Rx). This is not an Orange Book product. This product may be administered only under a physician’s supervision and all prescriptions using this product shall be pursuant to state statutes as applicable. The ingredients, indication or claims of this product are not to be construed to be drug claims.


1. Federal Register Notice of August 2, 1973 (38 FR 20750)
2. Federal Register Notice of October 17, 1980 (45 FR 69043, 69044)
3. Federal Register Notice of March 5, 1996 (61 FR 8760)

Dietary Supplement

Product Label

Primary Label

FOLIKA-V 
ascorbic acid, cholecalciferol, thiamine, vitamin b6. folate, vitamin b12, nahd, coenzyme q10 tablet
Product Information
Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:71800-005
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID125 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL0.0125 mg
THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE25 mg
PYRIDOXINE (UNII: KV2JZ1BI6Z) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE12.5 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1.67 mg
METHYLCOBALAMIN (UNII: BR1SN1JS2W) (METHYLCOBALAMIN - UNII:BR1SN1JS2W) METHYLCOBALAMIN1000 mg
NADH (UNII: 4J24DQ0916) (NADH - UNII:4J24DQ0916) NADH5 mg
UBIDECARENONE (UNII: EJ27X76M46) (UBIDECARENONE - UNII:EJ27X76M46) UBIDECARENONE50 mg
Inactive Ingredients
Ingredient NameStrength
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:71800-005-3030 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
dietary supplement11/30/201709/01/2019
Supplement Facts
Serving Size : Serving per Container :
Amount Per Serving% Daily Value
shape
scoring1
color
size (solid drugs)12 mm
Labeler - Innovida Phamaceutique Corporation (080892908)
Registrant - Innovida Phamaceutique Corporation (080892908)

Revised: 6/2019
 
Innovida Phamaceutique Corporation