Davimet-M

Manufacturer
PureTek Corporation
Effective date
2023-11-30
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:55:48

Label at a glance#

ProductDavimet-M
Active ingredientVITAMIN A, ASCORBIC ACID, SODIUM ASCORBATE, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, THIAMINE MONONITRATE, RIBOFLAVIN, NIACIN, LEVOMEFOLATE CALCIUM, METHYLCOBALAMIN
Label structure10 sections

Indications and uses

Davimet-M™ Multivitamin Chewable Tablets 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 product is contraindicated in patients with known hypersensitivity to any of its ingredients.

Dosage and administration

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

Storage and handling

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].

Label contents#

Full prescribing information#

Each Chewable Tablet Contains:

DESCRIPTION SECTION

Vitamin A (as Retinyl Acetate).................................... 750 mcg RAE
Vitamin C (as Sodium Ascorbate & Ascorbic Acid).............. 60 mg
Vitamin D3 (as Cholecalciferol)............................................ 10 mcg
Vitamin E (as DL-Alpha Tocopheryl Acetate)........................ 10 mg
Thiamin (as Thiamine Mononitrate).................................... 1.05 mg
Riboflavin............................................................................... 1.2 mg
Niacin (as Niacinamide)....................................................... 13.5 mg
Vitamin B6 (as Pyridoxine Hydrochloride).......................... 1.05 mg
Folate (as L-5-Methyltetrahydrofolate calcium salt)…1700 mcg DFE
(1000 mcg as L-5-Methylfolate)
Vitamin B12 (as Methylcobalamin)..................................... 4.5 mcg

Other Ingredients:

SPL UNCLASSIFIED SECTION

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

Phenylketonurics: Phenylalanine 3.0 mg Per Tablet.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Davimet-M™ Multivitamin Chewable Tablets 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.

Contraindications:

CONTRAINDICATIONS SECTION

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

WARNING

WARNINGS SECTION

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

PRECAUTIONS SECTION

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.

Use only under the direction of a licensed healthcare practitioner. 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:

ADVERSE REACTIONS SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

HOW SUPPLIED

HOW SUPPLIED SECTION

Multivitamin chewable tablets are light purple with speckles, grape flavor, un-scored, round tablets. Available on prescription only in bottle of 30 tablets – NDC 59088-158-54. Dispense in a tight, light resistant container with a child resistant closure as defined in the USP/NF. All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.

STORAGE

STORAGE AND HANDLING SECTION

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].

Davimet-M™

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Manufactured in the USA by:
PureTek Corporation

Panorama City, CA 91402
Questions? Call toll-free:
1-877-921-7873

labellabel

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASCORBIC ACID Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CHOLECALCIFEROL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
LEVOMEFOLIC ACID Pharmacologic Class Indexing1Indexing - Pharmacologic Class20230428
NIACIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PYRIDOXINE Pharmacologic Class Indexing1Indexing - Pharmacologic Class20170310
VITAMIN A Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cf050ccd-1144-f76a-e00d-e5698d8597d4Product name620250625
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
e2dae634-14ed-febf-08ee-93196433b5b7Product name920190614
ddff2484-d547-4e6a-bacd-95eef7e31c64Product name220180807
90854981-3820-4bc4-a1d3-666ec508941cProduct name220180214
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508
6b7a6f32-42a6-994d-5ab6-d180e92ee9d8Product name120140508
d394f843-7479-dc48-dbd3-232266c5548cProduct name120140508
dc9a5fb6-14e2-1cc8-a567-a781fd1f0212Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59088-158-54Davimet-M30 in 1 BOTTLE, PLASTICTABLET, CHEWABLE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-158DAVIMET-M (MULTIVITAMIN) TABLET, CHEWABLE [PURETEK CORPORATION]1Current NDC, 1 package rows20231201_0b67e8de-d81e-0fda-e063-6394a90ac229.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-158-54EA - Each59088-158672acb11-34ea-4d87-97da-a76a64fe040b12024-01-04

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59088-15859088-158-54

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Davimet-MMULTIVITAMINPureTek Corporation0b67e8de-d81e-0fda-e063-6394a90ac2292023-11-30Warnings, Adverse reactionsExact identifier
ndc (package): 59088-158-54
ndc (product): 59088-158
ndc11 (package): 59088015854
spl id: 0b67e8de-d81d-0fda-e063-6394a90ac229
spl set id: 0b67e8de-d81e-0fda-e063-6394a90ac229

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.