Label: NEWFOLIC- folic acid and vitamin d3 capsule
- NHRIC Code(s): 82379-1300-1
- Packager: Trell Pharma
- Category: DIETARY SUPPLEMENT
- DEA Schedule: None
- Marketing Status: Dietary Supplement
Drug Label Information
Updated September 21, 2023
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STATEMENT OF IDENTITY
NewFolic
Other Ingredients: Microcrystalline Cellulose, Magnesium Stearate & Vegatable Capsules
NewFolic is an orally administered prescription folate product for the dietary management of patients with unique nutritional needs requiring increased folate levels and Vitamin D supplementation due to Vitamin D deficiency.
NewFolic is manufactured in accordance with Current Good Manufacturing Practice for foods, using ingredients that have been approved by the U.S. Food and Drug Administration (FDA) as food additives or are Generally Recognized as Safe (GRAS) for their intended use.
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WARNINGS AND PRECAUTIONS
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
NewFolic should only be used under the direction and supervision of a licensed medical practitioner. 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.
Each tablet contains:
Folic Acid ..........................................................................1700 mcg DFE
(Folic Acid 1000mcg)
Vitamin D3 (Cholecalciferol) ...................................... 75 mcg
(3000 IU)
Tell your doctor if you have: kidney problems, thyroid disease. This medication should be used as directed during pregnancy or while breast-feeding. Consult your doctor about the risks and benefits.
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.
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
You should call your doctor for medical advice about serious adverse events. To report adverse side effects or to obtain product information, contact PureTek Corporation, at 1-813-576-1843.
KEEP OUT OF REACH OF CHILDREN
- STORAGE AND HANDLING SECTION
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HEALTH CLAIM:
NewFolic is used for dietary management of patients with unique nutritional needs requiring increased folate levels, Vitamin D deficiency or are in need of Vitamin D supplementation and other nutritional supplementation.
NewFolic can be taken by women of childbearing age, pregnant women, and lactating and nonlactating mothers.
- Package Label
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INGREDIENTS AND APPEARANCE
NEWFOLIC
folic acid and vitamin d3 capsuleProduct Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:82379-1300 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1 mg VITAMIN D (UNII: 9VU1KI44GP) (CHOLECALCIFEROL - UNII:1C6V77QF41) VITAMIN D 75 ug Inactive Ingredients Ingredient Name Strength MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) MAGNESIUM STEARATE (UNII: 70097M6I30) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:82379-1300-1 30 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date DIETARY SUPPLEMENT 09/21/2023 Supplement Facts Serving Size : Serving per Container : Amount Per Serving % Daily Value color shape size (solid drugs) 24 mm scoring 1 Labeler - Trell Pharma (118380801)
