Folic-K Capsules

Basic Information

Product Label

Product label for Folic-K Capsules
Full Name: Folic-K Capsules
Brand: Foxland Pharmaceuticals none
Product Type: Other Combinations
Physical State: Capsule
UPC/SKU: 3 69067-105-30 2
Product Version Code: Rev. 10/18

Contact Information

Manufactured for

Name: Foxland Pharmaceuticals, Inc.
Address:Trussville, AL, 35173
Types: Distributor

Product Details

Net Contents

30 Capsule(s)(30 Capsule(s))

Serving Sizes

Unit:Capsule(s)
Quantity:1 - 1
Daily Servings:1 - 2

Target Groups

Adult (18 - 50 Years)Women (not pregnant or lactating)

Servings Per Container

30

Ingredients & Nutrition

Co-Enzyme Q10

non-nutrient/non-botanical

Group: Coenzyme Q-10

Also known as: as ubiquinone

CoQ10

non-nutrient/non-botanical

Group: Coenzyme Q-10

Also known as: Coenzyme Q10, Co-Enzyme Q-10, Kaneka QH(TM), BioQ10-SA(TM), co-enzyme Q10, MicroActive Q10

Folacin

vitamin

Group: Vitamin B9 (folic acid)

Also known as: Folic Acid

Folate

vitamin

Group: Vitamin B9 (Folate)

Folate, also known as Vitamin B9, is a water-soluble vitamin essential for DNA synthesis, cell growth, and the production of red blood cells. It is important for proper brain function and plays a crucial role in mental and emotional health. Folate is naturally found in a wide range of foods, including leafy green vegetables, fruits, nuts, beans, and dairy products. It is also available as a dietary supplement and is typically included in B-vitamin complexes.

Folic Acid

vitamin

Group: Folate

Also known as: Orgen-FA, Vitamin B9, Quatrefolic, Folacin, CitraFolic, B9, Folate

UNII Code: 935E97BOY8

Group: Collagen

Hydrolyzed collagen is a form of collagen that has been broken down into smaller peptides, ensuring ease of digestion and absorption in the human body. Collagen is the most abundant protein in the body and is essential for maintaining healthy skin, bones, and connective tissues. Hydrolyzed collagen is often used as a supplement to support skin health, joint health, and overall wellness.

Also known as: Gelatin

Group: Cellulose

Microcrystalline cellulose (MCC) is a refined wood pulp that is commonly used as a texturizer, anti-caking agent, and bulking agent in food and dietary supplements. It is a white, odorless powder that is insoluble in water and is often used to improve the texture and stability of products.

Also known as: Cellulose, MCC

Group: Pregelatinized starch

Group: Vitamin B6 (pyridoxine)

Pyridoxine, commonly known as Vitamin B6, is a water-soluble vitamin that plays a critical role in brain health, production of neurotransmitters, and the metabolism of proteins, fats, and carbohydrates. It is essential for the proper functioning of sugars, fats, and proteins in the body and is crucial for the development of the brain and nervous system.

Also known as: Vitamin B6

Riboflavin

vitamin

Group: Vitamin B2 (Riboflavin)

Also known as: Vitamin B-2, vitamin B2, Vitamin B2, B2, activated B2, B-2, Vit. B2, pure powder B-2

UNII Code: TLM2976OFR

Group: Silicon

Also known as: SiO2

UNII Code: ETJ7Z6XBU4

Thiamine

vitamin

Group: Thiamin

Also known as: Vitamin B1, B1, Vitamin B-1, B-1

UNII Code: X66NSO3N35

Thioctic Acid

non-nutrient/non-botanical

Group: Alpha Lipoic Acid

Also known as: R-Alpha Lipoic Acid, Alpha Lipoic Acid

Vitamin B1

vitamin

Group: Vitamin B1 (unspecified)

Vitamin B1, also known as Thiamine, is a water-soluble vitamin that is crucial for energy metabolism and plays a significant role in the functioning of nerves, muscles, and the heart.

Also known as: Thiamine

Group: Vitamin B12

UNII Code: 8406EY2OQA

Vitamin B2

vitamin

Group: Vitamin B2 (unspecified)

Vitamin B2, also known as Riboflavin, is a vital nutrient that belongs to the vitamin B complex. It plays a crucial role in energy production and the metabolism of fats, drugs, and steroids. Riboflavin is found in foods like eggs, green vegetables, milk, and meat, as well as in fortified foods and supplements.

Also known as: Riboflavin

Group: Folate

Vitamin B9, commonly known as folic acid or folate, is a B-vitamin essential for various bodily functions, including DNA synthesis and repair, cell division, and growth. It is particularly important during periods of rapid growth such as during pregnancy and fetal development. Folic acid is the synthetic form often used in supplements and fortified foods, while folate is the naturally occurring form found in certain foods.

Also known as: Folic Acid, Folate

UNII Code: 935E97BOY8

Product Statements

Suggested/Recommended/Usage/Directions

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

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)

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