NEWFOLIC- folic acid and vitamin d3 capsule

NewFolic by

Drug Labeling and Warnings

NewFolic by is a Other medication manufactured, distributed, or labeled by Trell Pharma. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

DOSAGE

Usual Adult dose is one capsule once daily, or as prescribed by a licensed medical practitioner.
If you are pregnant or nursing, ask a healthcare professional.

NewFolic should be administered under the supervision of a licensed medical practitioner.

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

Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].

Protect from heat, light and moisture.

Manufactured for Trell Pharma

Tampa, FL 

Questions? Call: 813-576-1843

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

INGREDIENTS AND APPEARANCE

NEWFOLIC 
folic acid and vitamin d3 capsule

Product 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)