FOLIKA-MG: Package Insert and Label Information

FOLIKA-MG- beta carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine hydrochloride, folic acid, cobalamin, biotin, calcium carbonate, ferrous bisglycinate, potassium iodide and magnesium oxide capsule
Innovida Phamaceutique Corporation

Dosage and Administration

Adults should take one (1) tablet daily, preferably with a meal or as recommended by a physician.

WARNING

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.

PRECAUTION
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.

ADVERSE REACTIONS

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.

HEALTH CLAIM:

Folika-MG Tablets

Dietary Supplement

DESCRIPTION:
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.

HOW SUPPLIED:
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

Dietary Supplement

Product Label

image description
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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
Product Information
Product Type Item Code (Source) NDC:71800-810
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETA CAROTENE (.BETA.-CAROTENE) BETA CAROTENE 0.3 mg
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 0.06 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 0.01 mg
.ALPHA.-TOCOPHEROL ACETATE, DL- (.ALPHA.-TOCOPHEROL, DL-) .ALPHA.-TOCOPHEROL, DL- 4.5 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE 26 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1.67 mg
COBALAMIN (COBALAMIN) COBALAMIN 0.013 mg
BIOTIN (BIOTIN) BIOTIN 0.013 mg
CALCIUM CARBONATE (CALCIUM CATION) CALCIUM CARBONATE 80 mg
FERROUS BISGLYCINATE (FERROUS CATION) FERROUS CATION 20 mg
POTASSIUM IODIDE (IODIDE ION) POTASSIUM IODIDE 0.150 mg
MAGNESIUM OXIDE (MAGNESIUM CATION) MAGNESIUM CATION 25 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
CROSCARMELLOSE SODIUM
POLYGLYCERYL-3 RICINOLEATE
SODIUM CITRATE
SILICON DIOXIDE
POLYVINYL ALCOHOL (100000 MW)
POLYETHYLENE GLYCOL 1000
FD&C YELLOW NO. 5
FD&C YELLOW NO. 6
TALC
TITANIUM DIOXIDE
Product Characteristics
Color orange (Dark Orange) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71800-810-30 30 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
dietary supplement 06/16/2020
Labeler — Innovida Phamaceutique Corporation (080892908)
Registrant — Innovida Phamaceutique Corporation (080892908)

Revised: 09/2020 Innovida Phamaceutique Corporation

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