FOLIKA-D- folic acid, cholecalciferol, folate tablet 
Innovida Phamaceutique Corporation

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Innovida FOLIKA-D

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.

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

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

Folika-D Tablets is an orally administered prescription vitamin formulation for the clinical dietary management of suboptimal nutritional status in patients where advanced folate supplementation is required and nutritional supplementation in physiologically stressful conditions for maintenance of good health is needed.

Folika-D Tablets Dietary Supplement

Dispensed by Prescription†

Folika-D tablets are supplied as round shape biconvex plain tablet, natural color, mostly white with a light yellow in a child-resistant bottle of 30ct. (71800-001-30*)

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)

Store at 20°-25°C (66°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature.]

Protect from heat, light and moisture.

Primary Label

FOLIKA-D 
folic acid, cholecalciferol, folate tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:71800-001
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1.67 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL0.094375 mg
Inactive Ingredients
Ingredient NameStrength
GELATIN (UNII: 2G86QN327L)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
Colorwhite (Natural color, mostly white) Scoreno score
ShapeROUNDSize5mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71800-001-3030 in 1 BOTTLE; Type 0: Not a Combination Product11/15/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other11/15/201711/15/2017
Labeler - Innovida Phamaceutique Corporation (080892908)
Registrant - Innovida Phamaceutique Corporation (080892908)

Revised: 12/2017
 
Innovida Phamaceutique Corporation