FOLIKA-CI- ascorbic acid, cholecalciferol, thiamine, pyridoxal, folic acid, cobalamin, calcium carbonate, ferrous bisglycinate,

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R), CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41), THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J), PYRIDOXAL 5-PHOSPHATE GLUTAMATE (UNII: UP2U9O910M) (PYRIDOXAL - UNII:3THM379K8A), FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8), COBALAMIN (UNII: 8406EY2OQA) (COBALAMIN - UNII:8406EY2OQA), CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB), FERROUS BISGLYCINATE (UNII

Fáanlegur frá:

Innovida Phamaceutique Corporation

Stjórnsýsluleið:

ORAL

Vörulýsing:

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)

Leyfisstaða:

Dietary Supplement

Vara einkenni

FOLIKA-CI- ASCORBIC ACID, CHOLECALCIFEROL, THIAMINE, PYRIDOXAL, FOLIC
ACID, COBALAMIN, CALCIUM
CARBONATE, FERROUS BISGLYCINATE, POTASSIUM IODIDE TABLET
INNOVIDA PHAMACEUTIQUE CORPORATION
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INNOVIDA FOLIKA-CI
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
manag