Label: FLOTREX- multivitamins, sodium fluoride 0.5 mg tablet, chewable

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated March 3, 2025

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  • DESCRIPTION:
    Active Ingredients: Each Chewable Tablet Contains: Vitamin A (as Retinyl Acetate)…………………………………..…750 mcg RAE - Vitamin C (as Sodium Ascorbate 36 mg / Ascorbic Acid 24 mg)… 60 mg ...
  • CLINICAL PHARMACOLOGY
    It is well established that fluoridation of the water supply (1 ppm fluoride) during the period of tooth development leads to a significant decrease in the incidence of dental caries. Flotrex ...
  • INDICATIONS AND USAGE
    This prescription chewable tablet is indicated for the prevention and treatment of vitamin and fluoride deficiencies in patients at high risk for dental caries and inadequate dietary intake of ...
  • Contraindications:
    This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. The American Academy of Pediatrics recommends that children up to the age 16, in areas where ...
  • WARNING
    Keep out of the reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. Caution:Do not eat or drink dairy products ...
  • PRECAUTION
    The suggested dose of - Flotrex™ Chewable Multivitamin Tablets with 0.5 mg Fluoride should not be exceeded, since dental fluorosis may result from continued ingestion of large amounts of ...
  • ADVERSE REACTIONS
    Folate: Allergic sensitization has been reported following both oral and parenteral administration of folate. Adverse reactions have been reported with specific vitamins and minerals but generally ...
  • DOSAGE AND ADMINISTRATION
    One tablet daily, to be dissolved in the mouth or chewed before swallowing. Do not give a chewable tablet to a child younger than 4 years old.
  • HOW SUPPLIED
    Flotrex™ Chewable Multivitamin Tablets with 0.5 mg Fluoride containing 0.5 mg fluoride are purple-colored, grape flavor, un-scored, tablets are available on prescription only in bottles of 30 ...
  • STORAGE
    Do not use if bottle seal is broken. Store at controlled room temperature 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].
  • Flotrex™ Chewable Multivitamin Tablets with 0.5 mg Fluoride
    Manufactured in the USA by: PureTek Corporation - Panorama City, CA 91402 - Questions? Call toll-free: 1-877-921-7873
  • INGREDIENTS AND APPEARANCE
    Product Information