Dosage: Usual adult dose is 1 capsule once or twice daily or as prescribed by a licensed medical practitioner.
Precautions re: Pregnant or Nursing or Prescription Medications
If you are pregnant or nursing, ask a healthcare professional.
Precautions re: Children
Keep out of reach of children
Storage
Storage: Store at 20 degrees-25 degrees C (68 degrees-77 degrees F); excursions permitted to 15 degrees-30 degrees C (59 degrees-86 degrees F) [See USP controlled room temperature.]
Formulation re: Other
Made in Canada
General Statements: All Other Content
69067-105-30
FDA Statement of Identity
Dietary Supplement
General Statements: All Other Content
Dispensed by prescription
Formula re: Contains
Description
Folic-K Capsules is an orally administered prescription vitamin formulation for the clinical dietary management of suboptimal nutritional status in patients where advanced folate, vitamin B supplementation, and maintenance of good health is needed.
Precautions re: All Other
Contraindications
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
Precautions re: All Other
Warnings and precautions
Folic-K Capsules should only be used under the direction and supervision of a licensed medical practitioner.
Precautions re: Pregnant or Nursing or Prescription Medications
Ingredients listed outside the Supplement Facts panel. Amounts and %DV are not required there, so they are not recorded.
Ingredients
Form
Gelatin
—
Magnesium Stearate
—
Microcrystalline Cellulose
—
pregelatinized Starch
—
Riboflavin (Vitamin B2)
—
Silicon Dioxide
—
Titanium Dioxide
—
Use with caution in patients that may have a medical condition, are pregnant, lactating, trying to conceive, under the age of 18, or taking other medications.
Precautions re: Children
Use with caution in patients that may have a medical condition, are pregnant, lactating, trying to conceive, under the age of 18, or taking other medications.
Precautions re: All Other
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.
Precautions re: Pregnant or Nursing or Prescription Medications
Pregnancy and lactation
Folic-K Capsules are not intended for use in pregnant or lactating patients.
Precautions re: All Other
Adverse reactions
You should call your doctor for medical advice about serious adverse events. To report adverse side effects or to obtain product information, contact Foxland Pharmaceuticals, Inc, at 1-844-430-7499.
Suggested/Recommended/Usage/Directions
Dosage and administration
Usual adult dose is 1 capsule once or twice daily or as prescribed by a licensed medical practitioner.
Formulation re: Other
How supplied
Folic-K Capsules are supplied as light yellow capsules imprinted with "105" in a child-resistant bottle of 30ct (69067-105-30)
Storage
Store at 20 degrees-25 degrees C (68 degrees-77 degrees F); excursions permitted to 15 degrees-30 degrees C (59 degrees-86 degrees F) [See USP controlled room temperature.]
Protect from heat, light and moisture.
Precautions re: Children
Keep out of the reach of children.
Precautions re: All Other
Tamper evident: Do not use if seal is broken or missing.
Formulation re: Other
Made in Canada
Precautions re: All Other
Foxland Pharmaceuticals, Inc. 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.
Precautions re: All Other
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)
Foxland Pharmaceuticals Folic-K Capsules | Supplement DB