FOLIKA-CI: Package Insert and Label Information

FOLIKA-CI- ascorbic acid, cholecalciferol, thiamine, pyridoxal 5-phosphate glutamate, folic acid, cobalamin, calcium carbonate, ferrous bisglycinate and potassium iodide tablet
Innovida Phamaceutique Corporation

WARNING AND PRECAUTIONS

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-CI 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-CI 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.

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.

KEEP OUT OF THE REACH OF CHILDREN.

Tamper Evident: Do not use if seal is broken or missing.

DOSAGE & ADMINISTRATION

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

HEALTH CLAIM:

FOLIKA-CI Tablets
Dietary Supplement

DESCRIPTION:
FOLIKA-CI 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-CI Tablets may be useful in improving the nutritional status of woman prior to conception.

HOW SUPPLIED:

FOLIKA-CI 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)

Dietary Supplement

Product label

image description
(click image for full-size original)

FOLIKA-CI
ascorbic acid, cholecalciferol, thiamine, pyridoxal, folic acid, cobalamin, calcium carbonate, ferrous bisglycinate, potassium iodide tablet
Product Information
Product Type Item Code (Source) NDC:71800-806
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 125 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 0.0125 mg
THIAMINE (THIAMINE ION) THIAMINE 1.4 mg
PYRIDOXAL 5-PHOSPHATE GLUTAMATE (PYRIDOXAL) PYRIDOXAL 5-PHOSPHATE GLUTAMATE 2.5 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1.67 mg
COBALAMIN (COBALAMIN) COBALAMIN 1 mg
CALCIUM CARBONATE (CALCIUM CATION) CALCIUM CARBONATE 200 mg
FERROUS BISGLYCINATE (FERROUS CATION) FERROUS CATION 13 mg
POTASSIUM IODIDE (IODIDE ION) POTASSIUM IODIDE 0.150 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
POLYGLYCERYL-3 RICINOLEATE
SODIUM CITRATE
SILICON DIOXIDE
POLYVINYL ALCOHOL (100000 MW)
POLYETHYLENE GLYCOL 1000
FD&C RED NO. 4
TALC
TITANIUM DIOXIDE
Product Characteristics
Color red (Red fil coating) Score no score
Shape OVAL Size 19mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71800-806-30 30 TABLET 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)

Revised: 09/2020 Innovida Phamaceutique Corporation

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