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
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].
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
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 59088-018-54. 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].
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