NEXOCHEW- beta carotene, ascorbic acid, sodium ascorbate, cholecalciferol, .alpha.-tocopherol acetate, thiamine mononitrate, riboflavin, niacin, pyridoxine hydrochloride, folic acid, 5-methyltetrahydrofolic acid, and cyanocobalamin tablet

Drug Labeling and Warnings

Drug Details [pdf]

STATEMENT OF IDENTITY

71741-463-30
Multivitamin Chewable Tablet
Dispense by Prescription
DESCRIPTION

FolaChew is a chewable prescription multivitamin.

ACTIVE INGREDIENTS

Supplement Facts
Serving size: 1 Tablet
Each Tablet Contains:		%Daily Value
Vitamin A (as Beta-Carotene)	1000 mcg RAE	111%
Vitamin C (as Sodium Ascorbate and Ascorbic Acid)	100 mg	111%
Vitamin D3 (as Cholecalciferol)	20 mcg	100%
Vitamin E (as dl-Alpha Tocopherol Acetate)	15 mg	100%
Thiamin (Vitamin B-1 as Thiamine Mononitrate)	1.2 mg	100%
Riboflavin (Vitamin B-2)	1.3 mg	100%
Niacin (as Niacinamide)	16 mg	100%
Vitamin B6 (as Pyridoxine HCl)	1.6 mg	123%
Folate	1.67 mg DFE	418%
(from Folic Acid)	0.67 mg DFE
(from 5-Methyl Tetrahydrofolate, Calcium Salt)	1 mg DFE
Vitamin B12 (as Cyanocobalamin)	2.4 mcg	100%

OTHER INGREDIENTS: Sorbitol, Natural and Artificial Flavors, Contains Less Than 2% of: Hydroxypropyl Methylcellulose, Locust Bean Gum, Carrageenan, Magnesium Stearate, Stearic Acid.

Preservative Free and Gluten Free. No Starch, Artificial Colors, Wheat, Yeast or Corn Added.

INDICATIONS AND USAGE

NexoChew is indicated to provide significant amounts of Vitamins A, C, D, E, thiamine, riboflavin, niacin, vitamin B6, vitamin B12, and folate to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop. NexoChew is formulated to provide essential nutrients, tailored to the needs of all individuals ages 4 years old and above, promoting overall health, energy, and vitality.
CONTRAINDICATIONS

This product is contraindicated in patients with known hypersensitivity to any of its ingredients.
HEALTH CLAIM

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
PRECAUTIONS

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress. NexoChew 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 Redmont Pharmaceuticals, LLC at 1-800-986-5909.
DOSAGE AND ADMINISTRATION

One tablet daily directed by licensed medical practitioner. Tablet should be chewed before swallowing.
HOW SUPPLIED
Bottles of 30 tablets (71741-463-301). Tablet is off-white, round.

This product is a prescription-folate with or without other dietary ingredients that – due to increased folate levels increased risk associated with masking B12 deficiency (pernicious anemia) requires administration under the care of a licensed medical practitioner (64 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. 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 statues 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)
1 Redmont Pharmaceuticals does not represent this product code to be National Drug Code (NDC). Product codes are formatted according to standard industry practice, to meet the formatting requirement by pedigree reporting and supply-chain control including pharmacies.

STORAGE

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Avoid excessive heat, light and moisture.

TAMPER EVIDIENT

Do not use if seal if broken or missing.

HEALTH CLAIM

MADE IN THE USA

Distributed by:
Redmont Pharmaceuticals, LLC
Birmingham, AL 35209
800-986-5909

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

PRINCIPAL DISPLAY PANEL - 30 Tablet Bottle Label

71741-463-30

NexoChew

Multivitamin Tablet

30 Chewable Tablets

Dispense by Prescription

Principal Display Panel - 30 Tablet Bottle Label

INGREDIENTS AND APPEARANCE

NEXOCHEW
beta carotene, ascorbic acid, sodium ascorbate, cholecalciferol, .alpha.-tocopherol acetate, thiamine mononitrate, riboflavin, niacin, pyridoxine hydrochloride, folic acid, 5-methyltetrahydrofolic acid, and cyanocobalamin tablet

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:71741-463
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BETA CAROTENE (UNII: 01YAE03M7J) (BETA CAROTENE - UNII:01YAE03M7J)	BETA CAROTENE	1000 ug
Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R)	Ascorbic Acid	70 mg
Sodium Ascorbate (UNII: S033EH8359) (Ascorbic Acid - UNII:PQ6CK8PD0R)	Ascorbic Acid	40 mg
Cholecalciferol (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41)	Cholecalciferol	20 ug
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1)	.ALPHA.-TOCOPHEROL ACETATE	15 mg
THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J)	THIAMINE	1.2 mg
Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR)	Riboflavin	1.3 mg
NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A)	NIACIN	16 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE	1.6 mg
Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8)	Folic Acid	0.4 mg
5-METHYLTETRAHYDROFOLIC ACID (UNII: TYK22LML8F) (5-METHYLTETRAHYDROFOLIC ACID - UNII:TYK22LML8F)	5-METHYLTETRAHYDROFOLIC ACID	0.6 mg
Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204)	Cyanocobalamin	0.0024

Ingredient Name	Strength
Inactive Ingredients
Sorbitol (UNII: 506T60A25R)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
Locust Bean Gum (UNII: V4716MY704)
Carrageenan (UNII: 5C69YCD2YJ)
MAGNESIUM PALMITOSTEARATE (UNII: R4OXA9G5BV)
Stearic Acid (UNII: 4ELV7Z65AP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NHRIC:71741-463-30	30 in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Dietary Supplement		01/02/2026

	Amount Per Serving	% Daily Value
Supplement Facts
Serving Size :		Serving per Container :
color
scoring	1
shape
size (solid drugs)	13 mm

Labeler - Redmont Pharmaceuticals, LLC (080843607)