MULTIVITAMIN CHEWABLE WITH METHYLFOLATE- multivitamin tablet, chewable

Multivitamin Chewable with Methylfolate by

Drug Labeling and Warnings

Multivitamin Chewable with Methylfolate by is a Other medication manufactured, distributed, or labeled by PureTek Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Each Chewable Tablet contains:

	Amount Per Serving	% Daily Value
Vitamin A (as Retinyl Acetate)	750 mcg RAE	83%
Vitamin C (as Sodium Ascorbate & Ascorbic Acid)	60mg	67%
Vitamin D3 (as Cholecalciferol)	10 mcg (400 IU)	50%
Vitamin E (as DL-Alpha Tocopheryl Acetate)	10 mg	67%
Thiamin (as Thiamine Mononitrate)	1.05 mg	88%
Riboflavin	1.2 mg	92%
Niacin (as Niacinamide)	13.5 mg	84%
Vitamin B6 (as Pyridoxine Hydrochloride)	1.05 mg	62%
Folate (as L-5-Methyltetrahydrofolate calcium salt)	1700 mcg DFE; (1000 mcg as L-5-Methylfolate)	425%
Vitamin B12 (as Methylcobalamin)	4.5 mcg	188%

Other Ingredients:

Sucrose, Microcrystalline Cellulose, Croscarmellose Sodium, Vegetable Stearic Acid, Magnesium Stearate, Grape Flavor, Aspartame, CI 45410 (Red 27 Lake), CI 42090 3844-45-9 (FD&C Blue No. 1 Aluminum Lake).

Phenylketonurics: Phenylalanine 3.0 mg Per Tablet.

INDICATIONS AND USAGE

Multivitamin Chewable Tablets with Methylfolate 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.

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

Contraindications:

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

WARNING

Keep out of the reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

CAUTION: Should be chewed.

PRECAUTIONS

Folate in doses above 0.1 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive. There is a potential danger in administering folate to patients with undiagnosed anemia, since folate may obscure the diagnosis of pernicious anemia by alleviating the hematologic manifestations of the disease while allowing the
neurologic complications to progress. This may result in severe nervous system damage before the correct diagnosis is made.
Adequate doses of vitamin B12 may prevent, halt, or improve the neurologic changes caused by pernicious anemia.

The patient’s medical conditions and consumption of other drugs, herbs, and/or supplements should be considered.

Call your doctor about side effects. To report side effects, call PureTek Corporation at 1-877-921-7873 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Adverse Reactions:

Folate: Allergic sensitizations has been reported following both oral and parenteral administration of folate. Adverse reactions have been reported with specific vitamins and minerals but generally at levels substantially higher than those contained herein. However, allergic and idiosyncratic reactions are possible at lower levels.

DOSAGE AND ADMINISTRATION

One tablet daily, to be dissolved in the mouth or chewed before swallowing.

HOW SUPPLIED

Multivitamin chewable tablets are light purple with speckles, grape flavor, un-scored, round tablets. Available in bottle of 30 tablets – NHRIC 59088-188-54. Dispense in a tight, light resistant container with a child resistant closure as defined in the USP/NF.

STORAGE

Do not use if bottle seal is broken.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Multivitamin Chewable Tablets with Methylfolate

NHRIC 59088-188-54 *

Multivitamin Chewable Tablet with Methylfolate

30 tablets

Manufactured in the USA by:
PureTek Corporation
Panorama City, CA 91402
Questions? Call toll-free:
1-877-921-7873

*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.

† The most appropriate way to ensure pedigree reporting consistent with these regulatory guidelines and safety monitoring is to dispense this product 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 statutes as applicable. The ingredients, indication or claims of this product are not to be construed to be drug claims.

INGREDIENTS AND APPEARANCE

MULTIVITAMIN CHEWABLE WITH METHYLFOLATE 
multivitamin tablet, chewable

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:59088-188
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
VITAMIN A (UNII: 81G40H8B0T) (VITAMIN A - UNII:81G40H8B0T)	VITAMIN A	750 ug
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	24 mg
SODIUM ASCORBATE (UNII: S033EH8359) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	36 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	10 ug
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01)	.ALPHA.-TOCOPHEROL, DL-	10 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE	1.05 mg
THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J)	THIAMINE	1.05 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR)	RIBOFLAVIN	1.2 mg
NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A)	NIACIN	13.5 mg
LEVOMEFOLATE CALCIUM (UNII: A9R10K3F2F) (LEVOMEFOLIC ACID - UNII:8S95DH25XC)	LEVOMEFOLATE CALCIUM	1000 ug
METHYLCOBALAMIN (UNII: BR1SN1JS2W) (METHYLCOBALAMIN - UNII:BR1SN1JS2W)	METHYLCOBALAMIN	4.5 ug

Inactive Ingredients
Ingredient Name	Strength
SUCROSE (UNII: C151H8M554)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STEARIC ACID (UNII: 4ELV7Z65AP)
ASPARTAME (UNII: Z0H242BBR1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:59088-188-54	30 in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
dietary supplement		08/28/2025

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

Labeler - PureTek Corporation (785961046)