Label: FOLIKA-MG- beta carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine hydrochloride, folic acid, cobalamin, biotin, calcium carbonate, ferrous bisglycinate, potassium iodide, magnesium oxide capsule
- NHRIC Code(s): 71800-810-30
- Packager: Innovida Phamaceutique Corporation
- Category: DIETARY SUPPLEMENT
- DEA Schedule: None
- Marketing Status: Dietary Supplement
Drug Label Information
Updated September 8, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Dosage and Administration
Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control central immediately.
Folika-MG tablets should only be used under the direction and supervision of a licensed medical practitioner. This product is contraindicated in patients with known hypersensitivity to any of the ingredients. 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 alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B is deficient. Folic acid in doses above 1mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress. Folika-MG Tablets should only be used under the direction and supervision of a licensed medical practitioner.
Allergic sensitization has been reported following both oral and parenteral administration of folic acid. You may report side effects by calling 304-303-5399 or the FDA by calling 1-800-FDA-1088.
KEEP OUT OF THE REACH OF CHILDREN.
Tamper Evident: Do not use if seal is broken or missing.
Folika-MG 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, such as throughout pregnancy, during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. Folika-MG Tablets may be useful in improving the nutritional status of woman prior to conception.
Folika-MG Tablets are supplied 30 tables in a child resistant bottle.
*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)
STORAGE AND HANDLING:
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
- STATEMENT OF IDENTITY
- Product Label
INGREDIENTS AND APPEARANCE
beta carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine hydrochloride, folic acid, cobalamin, biotin, calcium carbonate, ferrous bisglycinate, potassium iodide, magnesium oxide capsule
Product Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:71800-810 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETA CAROTENE (UNII: 01YAE03M7J) (.BETA.-CAROTENE - UNII:01YAE03M7J) BETA CAROTENE 0.3 mg ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 0.06 mg CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 0.01 mg .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL- 4.5 mg PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE 26 mg FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1.67 mg COBALAMIN (UNII: 8406EY2OQA) (COBALAMIN - UNII:8406EY2OQA) COBALAMIN 0.013 mg BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN 0.013 mg CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE 80 mg FERROUS BISGLYCINATE (UNII: SFW1D987QV) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 20 mg POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) POTASSIUM IODIDE 0.150 mg MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CATION 25 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W) SODIUM CITRATE (UNII: 1Q73Q2JULR) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) POLYVINYL ALCOHOL (100000 MW) (UNII: 949E52Z6MY) POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:71800-810-30 30 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date dietary supplement 06/16/2020 Supplement Facts Serving Size : Serving per Container : Amount Per Serving % Daily Value shape scoring 1 color size (solid drugs) 19 mm Labeler - Innovida Phamaceutique Corporation (080892908) Registrant - Innovida Phamaceutique Corporation (080892908)