Multivitamin Chewable Tablets

Manufactured in the USA by:

PureTek Corporation

Panorama City, CA 91402

Questions? Call toll-free:

1-877-921-7873

INDICATIONS AND USAGE

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.

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.

HOW SUPPLIED

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

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].

DOSAGE AND ADMINISTRATION

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

Each Chewable Tablet Contains:

Vitamin A (as Retinyl Acetate).................................... 750 mcg RAE

Vitamin C (as Sodium Ascorbate and 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:

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.

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.

Use only under the direction of a licensed healthcare practitioner. Call your doctor about side effects. To report side effects, callPureTek Corporation at1-877-921-7873 or** FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.**