TL-FLUORIVITE- vitamin a, ascorbic acid, vitamin d, .alpha.-tocopherol, thiamine mononitrate, riboflavin, niacin, pyridoxine, folic acid, cyanocobalamin, biotin, pantothenic acid, iron, magnesium, zinc, copper, and sodium fluoride tablet, chewable
Trigen Laboratories, LLC

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MULTI-VITAMIN WITH IRON AND FLUORIDE
0.25mg CHEWABLE TABLETS

Rx Only

DESCRIPTION

Chewable tablets containing multivitamins with iron and fluoride 0.25 mg are sugar free, dye free, off-white speckled, round shape, fruit flavor chewable tablets debossed TL on one side and 530 on the other.

Supplement Facts
Serving Size: 1 Chewable Tablet % Daily Value Adults & Children 4 Years or More
Amount Per Tablet
*
Daily value not established. Ingredient for caries prophylaxis: *Fluoride as sodium fluoride.
Vitamin A 1000 IU 20%
Vitamin C 100 mg 180%
Vitamin D 400 IU 100%
Vitamin E 30 IU 100%
Thiamine 1.5 mg 100%
Riboflavin 1.7 mg 100%
Niacin 20 mg 100%
Vitamin B 6 2 mg 100%
Folic Acid 400 mcg 100%
Vitamin B 12 9 mcg 150%
Biotin 45 mcg 15%
Pantothenic Acid 10 mg 100%
Iron 7.5 mg 42%
Magnesium 60 mg 15%
Zinc 7.5 mg 50%
Copper 1 mg 50%
Fluoride 0.25 mg *

Inactive ingredients: Xylitol, Carregeenan, Microcrystalline Cellulose, Natural Fruit Flavor, Citric Acid, Croscarmellose Sodium, Silicon Dioxide, Crospovidone, Magnesium Stearate, Sucralose.

PHARMACOLOGY

It is well established that fluoridation of the water supply (1 ppm fluoride) during period of tooth development leads to a significant decrease in the incidence of dental caries. TL-Fluorivite Chew multi-vitamin with Iron and Fluoride Chewable Tablets provide sodium fluoride, magnesium, zinc, copper, twelve essential vitamins, and iron in a chewable tablet. Because tablets are chewable, they provide a topical as well as systemic source of fluoride.

Hydroxyapatite is the principal crystal for all calcified tissue of the human body. The fluoride ion reacts with the hydroxyapatite in the tooth as it is formed to produce the more caries-resistant crystal fluorapatite. The reaction may be expressed by the equation:

Ca 10 (PO 4 ) 6 (OH) 2 + 2F- →Ca 10 (PO 4 )F 2 + 2OH-
(Hydroxyapatite) (Flourapatite)

Three stages of fluoride deposition in tooth enamel can be distinguished:

  • Small amounts (reflecting the low levels of fluoride in tissue fluids) are incorporated into the enamel crystals while they are being formed.
  • After enamel has been laid down, fluoride deposition continues in the surface enamel. Diffusion of fluoride from the surface inward is apparently restricted.
  • After eruption, the surface enamel acquires fluoride from water, food supplementary fluoride and smaller amounts from saliva.

TL-Fluorivite Chew multi-vitamin with Iron and Fluoride Chewable Tablets is a prescription product for the dietary management of the metabolic processes of caries prophylaxis, and provides supplementation of the diet with twelve essential vitamins, magnesium, zinc, copper, and iron.

TL-Fluorivite Chew multi-vitamin with Iron and Fluoride 0.25mg Chewable Tablets provide 0.25 mg of fluoride in tablet form for children 4-6 years of age where the drinking water contains 0.3 through 0.6 ppm of fluoride.

TL-Fluorivite Chew multi-vitamin with Iron and Fluoride Chewable Tablets supply significant amount of Vitamins A,C,D,E, thiamine, riboflavin, niacin, vitamin B 6 , vitamin B 12 , folate, biotin, pantothenic acid, magnesium, zinc, copper to supplement the diet, and to help assure that the nutritional deficiencies of these vitamins will not develop. Thus, in a single easy-to-use preparation, children obtain twelve essential vitamins and the important minerals, magnesium, zinc, copper, iron, and fluoride.

The American Academy of Pediatrics recommends that children up to the age of 16, in areas where drinking water contains less than optimal levels of fluoride, receive daily fluoride supplementation.

Children using TL-Fluorivite Chew multi-vitamin with Iron and Fluoride Chewable Tablets regularly should receive semiannual dental examinations. The regular brushing of teeth and attention to good oral hygiene practices are also essential.

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poising in children under age 6. KEEP THIS PRODUCT OUT OF REACH OF CHILDREN. In case of accidental overdose, call a doctor or Poison Control Center immediately.

Tablets should be chewed or crushed before they are swallowed.

This product is not recommended for children under age 4 due to risk of choking.

PRECAUTIONS

The suggested dose of TL-Fluorivite Chew multi-vitamin with Iron and Fluoride Chewable Tablets should not be exceeded, since dental fluorosis may result for continued ingestion of large amounts of fluoride.

Before prescribing TL-Fluorivite Chew multi-vitamin with Iron and Fluoride Chewable Tablets:

  • Determine the fluoride content of the drinking water form all major sources.
  • Make sure the child is not receiving significant amounts of fluoride from other sources such as medications and swallowed toothpaste.
  • Periodically check to make sure that the child does not develop significant dental fluorosis.

Your doctor or dentist is the best source of counsel and guidance in your child's fluoride supplementation.

ADVERSE REACTION

Allergic rash and other idiosyncrasies have been rarely reported.

RECOMMENDED USE

One tablet daily or as prescribed by doctor, or dentist.

HOW SUPPLIED

TL-Fluorivite Chew is supplied in child-resistant bottles of 100 chewable tablets.

STORAGE

Store at 25° (77°F); excursions permitted to 15°-30°C (59°-86°F). See USP Controlled Room Temperature. Protect from light and moisture.

KEEP OUT OF REACH OF CHILDREN.

Manufactured For:
TRIGEN Laboratories, Inc.
Sayreville, NJ 08872
www.trigenlab.com

Rev. 09/12

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

13811-530-10
R x Only

TL-Fluorivite
Chew

Multivitamin Supplement
with Iron and Fluoride

Natural Fruit Flavor

100 CHEWABLE TABLETS

TRIGEN
LABORATORIES

Principal Display Panel - 100 Tablet Bottle Label
TL-FLUORIVITE
vitamin a, ascorbic acid, vitamin d, .alpha.-tocopherol, thiamine mononitrate, riboflavin, niacin, pyridoxine, folic acid, cyanocobalamin, biotin, pantothenic acid, iron, magnesium, zinc, copper, and sodium fluoride tablet, chewable
Product Information
Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:13811-530
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Vitamin A (UNII: 81G40H8B0T) (Vitamin A - UNII:81G40H8B0T) Vitamin A 1000 [iU]
Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid 100 mg
Vitamin D (UNII: 9VU1KI44GP) (Vitamin D - UNII:9VU1KI44GP) Vitamin D 400 [iU]
.Alpha.-Tocopherol (UNII: H4N855PNZ1) (.Alpha.-Tocopherol - UNII:H4N855PNZ1) .Alpha.-Tocopherol 30 [iU]
Thiamine Mononitrate (UNII: 8K0I04919X) (Thiamine Ion - UNII:4ABT0J945J) Thiamine 1.5 mg
Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR) Riboflavin 1.7 mg
Niacin (UNII: 2679MF687A) (Niacin - UNII:2679MF687A) Niacin 20 mg
Pyridoxine (UNII: KV2JZ1BI6Z) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine 2 mg
Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid 400 ug
Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204) Cyanocobalamin 9 ug
Biotin (UNII: 6SO6U10H04) (Biotin - UNII:6SO6U10H04) Biotin 45 ug
Pantothenic Acid (UNII: 19F5HK2737) (Pantothenic Acid - UNII:19F5HK2737) Pantothenic Acid 10 mg
Iron (UNII: E1UOL152H7) (Iron - UNII:E1UOL152H7) Iron 7.5 mg
Magnesium (UNII: I38ZP9992A) (Magnesium - UNII:I38ZP9992A) Magnesium 60 mg
Zinc (UNII: J41CSQ7QDS) (Zinc - UNII:J41CSQ7QDS) Zinc 7.5 mg
Copper (UNII: 789U1901C5) (Copper - UNII:789U1901C5) Copper 1 mg
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion 0.25 mg
Inactive Ingredients
Ingredient Name Strength
Xylitol (UNII: VCQ006KQ1E)
Carrageenan (UNII: 5C69YCD2YJ)
Cellulose, Microcrystalline (UNII: OP1R32D61U)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Croscarmellose Sodium (UNII: M28OL1HH48)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
CROSPOVIDONE (UNII: 2S7830E561)
Magnesium Stearate (UNII: 70097M6I30)
Sucralose (UNII: 96K6UQ3ZD4)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NHRIC:13811-530-10 100 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
DIETARY SUPPLEMENT 10/15/2012 09/30/2015
Supplement Facts
Serving Size : Serving per Container :
Amount Per Serving % Daily Value
color
flavor
imprint
scoring 1
shape
size (solid drugs) 16 mm
Labeler - Trigen Laboratories, LLC (830479668)

Revised: 11/2019
Trigen Laboratories, LLC