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Davimet Tablets

Package insert / prescribing information
Generic name: multivitamin
Dosage form: tablet, chewable
Drug class: Vitamin and mineral combinations

Medically reviewed by Drugs.com. Last updated on Sep 1, 2022.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. Read further information about unapproved drugs.

Each Chewable Tablet Contains:

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 .....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 folic acid).....1667 mcg DFE (1000 mcg folic acid)
Vitamin B12 (as cyanocobalamin).....4.5 mcg

Other Ingredients:

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 for Davimet Tablets

Davimet™ 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:

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

Folic acid 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 folic acid to patients with undiagnosed anemia, since folic acid 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.

For use on the order of a 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:

Folic Acid: Allergic sensitizations has been reported following both oral and parenteral administration of folic acid. 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.

Davimet Tablets Dosage and Administration

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

How is Davimet Tablets Supplied

Multivitamin chewable tablets are light purple with speckles, grape flavor, un-scored, round tablets. Available on prescription only in
bottles of 30 tablets – NDC 59088-695-54. 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

Do not use if bottle seal is broken. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Store at controlled room temperature 20° to 25°C (68° to 77°F). [See USP].
Protect from light and moisture and avoid excessive heat.

Davimet™

Manufactured in the USA by:
PureTek Corporation

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

DAVIMET
multivitamin tablet, chewable
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:59088-695
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VITAMIN A (VITAMIN A) VITAMIN A 750 ug
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 24 mg
SODIUM ASCORBATE (ASCORBIC ACID) ASCORBIC ACID 36 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 10 ug
.ALPHA.-TOCOPHEROL ACETATE, DL- (.ALPHA.-TOCOPHEROL, DL-) .ALPHA.-TOCOPHEROL, DL- 10 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE 1.05 mg
THIAMINE MONONITRATE (THIAMINE ION) THIAMINE 1.05 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 1.2 mg
NIACIN (NIACIN) NIACIN 13.5 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1667 ug
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 4.5 ug
Inactive Ingredients
Ingredient Name Strength
SUCROSE
CROSCARMELLOSE SODIUM
D&C RED NO. 27
FD&C BLUE NO. 1
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STEARIC ACID
ASPARTAME
Product Characteristics
Color purple (Light Purple) Score no score
Shape ROUND Size 13mm
Flavor GRAPE (Grape flavor) Imprint Code
Contains
Packaging
# Item Code Package Description
1 NDC:59088-695-54 30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 09/19/2022
Labeler - PureTek Corporation (785961046)
PureTek Corporation

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