FOLIKA-NC by Innovida Phamaceutique Corporation Innovida FOLIKA-NC

FOLIKA-NC by

Drug Labeling and Warnings

FOLIKA-NC by is a Other medication manufactured, distributed, or labeled by Innovida Phamaceutique Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

FOLIKA-NC- ascorbic acid, thiamine, riboflavin, niacinamide, pyridoxine hydrochloride, cobalamin, biotin, pantothenic acid, folic acid tablet 
Innovida Phamaceutique Corporation

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Innovida FOLIKA-NC

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

PRECAUTIONS

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

FOLIKA-NC 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.

Folic acid supplementation may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations progress.

Keep out of reach of children. Pregnancy and Lactation:

FOLIKA-NC Tablets is not intended for use in pregnant or lactating patients

ADVERSE REACTIONS

Allergic sensitizations have been reported following oral administration of folic acid. Consult your physician immediately if adverse side effects occur.

DOSAGE AND ADMINISTRATION

Usual adult dose is 1 tablet by mouth once or twice daily or as prescribed by a licensed medical practitioner.

HEALTH CLAIM:

FOLIKA-NC
Dietary Supplement
Dispensed by Prescription

HOW SUPPLIED HEALTH CLAIM:

FOLIKA-NC Tablets are supplied as a small, round, yellow, clear-coated tablet, with debossed "A" on one side.

Store at 20° to 25°C (68° to 77°F; excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]

Manufactured for: Innovida Pharmaceutique Corporation

Call your doctor for medical advice about side effects. You may report side effects to Innovida Pharmaceutique at 1-888-919-0980

*Innovida Pharmaceutique Corp. 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). 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.

Dietary Supplement

Product Label

Label

FOLIKA-NC 
ascorbic acid, thiamine, riboflavin, niacinamide, pyridoxine hydrochloride, cobalamin, biotin, pantothenic acid, folic acid tablet
Product Information
Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:71800-814
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID100 mg
THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE1.5 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN1.7 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE20 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE10 mg
COBALAMIN (UNII: 8406EY2OQA) (COBALAMIN - UNII:8406EY2OQA) COBALAMIN0.006 mg
BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN0.3 mg
PANTOTHENIC ACID (UNII: 19F5HK2737) (PANTOTHENIC ACID - UNII:19F5HK2737) PANTOTHENIC ACID10 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1.67 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:71800-814-3030 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
dietary supplement06/16/202003/03/2021
Supplement Facts
Serving Size : Serving per Container :
Amount Per Serving% Daily Value
shape
scoring1
color
size (solid drugs)10 mm
Labeler - Innovida Phamaceutique Corporation (080892908)

Revised: 3/2021