Source label information, not individualized medical advice. This record applies to the product and labeler shown below. Compare the exact formulation, strength and country with your package and the current source label.
Generic nameMULTIVITAMIN
Labeler / manufacturerPureTek Corporation
RouteORAL
Drug classVitamin A / Vitamin C / Vitamin D / Nicotinic Acid / Vitamin B12
Product NDC59088-695
Label effective date2024-09-13
Official product label reference
Davimet — PureTek Corporation
This page contains 10 source sections for MULTIVITAMIN, oral route. Label set e4a57710-caa9-51e5-e053-2a95a90a8ad0, version 5.
Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.
Uses described in the label
INDICATIONS AND USAGE 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. Expressly 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.
Dosage and administration — label text
DOSAGE AND ADMINISTRATION One tablet daily, to be dissolved in the mouth or chewed before swallowing.
Contraindications
Contraindications: This product is contraindicated in patients with known hypersensitivity to any of its ingredients.
Warnings
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.
Adverse reactions
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.
Product description
Active ingredients: 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 (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
Unclassified section
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.
Precautions
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.
Supply and packaging
HOW 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 and handling
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] Protect from light and moisture and avoid excessive heat.
The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.