Supplementation of the diet with ten essential vitamins. Supplementation of the diet with fluoride for caries prophylaxis. The American Academy of Pediatrics recommends that children up to age 16, in areas where drinking water contains less than optimal levels of fluoride, receive daily fluoride supplements. Multivitamin with 1.0 mg Fluoride Chewable Tablets provide 1.0 mg fluoride in tablet form for children 6-16...
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.
Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). See USP Controlled Room Temperature. 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.
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).
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.
Multivitamin with 1.0 mg Fluoride Chewable Tabletsprovide sodium fluoride and ten essential vitamins in a chewable tablet. Because the tablets are chewable, they provide a topical as well as systemic source of fluoride. Hydroxyapatite is the principal crystal for all calcified tissue in 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) 6F 2 + 2OH-
(Hydroxyapatite) (Fluorapatite)
Three stages of fluoride deposition in tooth enamel can be distinguished:
1. Small amounts (reflecting the low levels of fluoride in tissue fluids) are incorporated into the enamel crystals while they are being formed.
2. After enamel has been laid down, fluoride deposition continues in the surface enamel. Diffusion of fluoride from the surface inward is apparently restricted.
3. After eruption, the surface enamel acquires fluoride from the water, food, supplementary fluoride and smaller amounts from saliva.
Supplementation of the diet with ten essential vitamins.
Supplementation of the diet with fluoride for caries prophylaxis.
The American Academy of Pediatrics recommends that children up to age 16, in areas where drinking water contains less than optimal levels of fluoride, receive daily fluoride supplements.
Multivitamin with 1.0 mg Fluoride Chewable Tabletsprovide 1.0 mg fluoride in tablet form for children 6-16 years of age in areas where the water fluoride level is less than 0.3 ppm.
Multivitamin with 1.0 mg Fluoride Chewable Tabletssupply significant amounts of Vitamins A, C, D, E, thiamine, riboflavin, niacin, vitamin B 6, vitamin B 12, and folate to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop. Thus, in a single easy-to-use preparation, children obtain ten essential vitamins and the important mineral, fluoride.
Children using Multivitamin with 1.0 mg Fluoride Chewable Tabletsregularly should receive semiannual dental examinations. The regular brushing of teeth and attention to good oral hygiene practices are also essential.
Multivitamin with Fluoride Chewable Tabletsis a prescription product for the clinical dietary management of the metabolic processes of caries prophylaxis and provides supplementation of the diet with ten essential vitamins.
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 within one hour of fluoride administration.
Should be chewed. This product, as all chewable tablets, is not recommended for children under age 4 due to risk of choking.
The suggested dose of Multivitamin with 1.0 mg Fluoride Chewable Tabletsshould not be exceeded, since dental fluorosis may result from continued ingestion of large amounts of fluoride.
Before prescribing Multivitamin with 1.0 mg Fluoride Chewable Tablets:
1. Determine the fluoride content of the drinking water from all major sources.
2. Make sure the child is not receiving significant amounts of fluoride from other sources such as medications and swallowed toothpaste.
3. Periodically check to make sure that the child does not develop significant dental fluorosis.
Phenylketonurics: Contains Phenylalanine 3.0 mg Per Tablet.
Allergic rash and other idiosyncrasies have been rarely reported.
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.
Multivitamin chewable tablets containing 1 mg fluoride are purple-colored, grape flavor, un-scored, round debossed "109" tablets are available on prescription only in bottles of 100 tablet bottles. NDC: 59088-109-59.
Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). See USP Controlled Room Temperature.
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.
Manufactured By: PureTek Corporation
Panorama City, CA 91402
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 59088-109-59 | 2021-01-05 | C162847 | 48780-1 | 97431aae-164f-960c-e053-dbdaa90a7534 | 59088-109 Multivitamin with Fluoride 1.0 mg Prescribing Information |
| 59088-109-59 | 2019-11-13 | C162847 | 48780-1 | 97431aae-164f-960c-e053-dbdaa90a7534 | 59088-109 Multivitamin with Fluoride 1.0 mg Prescribing Information |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 59088-109-59 | EA - Each | 59088-109 | e4f8f5c0-4cac-42a7-ad34-af68e42f03c8 | 1 | 2012-07-24 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| .ALPHA.-TOCOPHEROL ACETATE, DL- | ACTIVE INGREDIENT | WR1WPI7EW8 | 1 | |
| ASCORBIC ACID | ACTIVE INGREDIENT | PQ6CK8PD0R | 1 | |
| CHOLECALCIFEROL | ACTIVE INGREDIENT | 1C6V77QF41 | 1 | |
| CYANOCOBALAMIN | ACTIVE INGREDIENT | P6YC3EG204 | 1 | |
| FOLIC ACID | ACTIVE INGREDIENT | 935E97BOY8 | 1 | |
| NIACINAMIDE | ACTIVE INGREDIENT | 25X51I8RD4 | 1 | |
| PYRIDOXINE HYDROCHLORIDE | ACTIVE INGREDIENT | 68Y4CF58BV | 1 | |
| RIBOFLAVIN | ACTIVE INGREDIENT | TLM2976OFR | 1 | |
| SODIUM ASCORBATE | ACTIVE INGREDIENT | S033EH8359 | 1 | |
| SODIUM FLUORIDE | ACTIVE INGREDIENT | 8ZYQ1474W7 | 1 | |
| THIAMINE MONONITRATE | ACTIVE INGREDIENT | 8K0I04919X | 1 | |
| VITAMIN A | ACTIVE INGREDIENT | 81G40H8B0T | 1 | |
| ALPHA-TOCOPHEROL | ACTIVE MOIETY | H4N855PNZ1 | 1 | |
| ASCORBIC ACID | ACTIVE MOIETY | PQ6CK8PD0R | 1 | |
| CHOLECALCIFEROL | ACTIVE MOIETY | 1C6V77QF41 | 1 | |
| CYANOCOBALAMIN | ACTIVE MOIETY | P6YC3EG204 | 1 | |
| FLUORIDE ION | ACTIVE MOIETY | Q80VPU408O | 1 | |
| FOLIC ACID | ACTIVE MOIETY | 935E97BOY8 | 1 | |
| NIACINAMIDE | ACTIVE MOIETY | 25X51I8RD4 | 1 | |
| PYRIDOXINE | ACTIVE MOIETY | KV2JZ1BI6Z | 1 | |
| RIBOFLAVIN | ACTIVE MOIETY | TLM2976OFR | 1 | |
| THIAMINE | ACTIVE MOIETY | X66NSO3N35 | 1 | |
| VITAMIN A | ACTIVE MOIETY | 81G40H8B0T | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | 1 | |
| D&C RED NO. 27 | INACTIVE INGREDIENT | 2LRS185U6K | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 1 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 59088-109 | 59088-109-59 |
Every source-derived ingredient row is available through these pages.
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| D&C RED NO. 27 | D&C RED NO. 27 | 2LRS185U6K | TABLET, CHEWABLE / ORAL | 7 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | 86 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | IMPLANT / SUBCUTANEOUS | 0.5 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | MOUTHWASH / BUCCAL | NA | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE, COATED PELLETS / ORAL | 456 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | SOLUTION / RECTAL | 35.42 %w/v | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | POWDER, FOR SOLUTION / ORAL | 0.04 mg/5ml | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / BUCCAL | 18 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | ELIXIR / ORAL | 18000 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | SUSPENSION, EXTENDED RELEASE / ORAL | 1120 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | SHAMPOO / TOPICAL | 9.7 %w/w | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / RECTAL | 0.01 %w/v | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / BUCCAL | 17.5 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | POWDER, FOR SUSPENSION / ORAL | 11.25 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | CAPSULE, COATED PELLETS / ORAL | 198 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, COATED / ORAL | 42.4 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / SUBLINGUAL | 17.5 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CREAM / VAGINAL | 1088 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER / RESPIRATORY (INHALATION) | 0.13 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / ORAL | 1.13 mg/15ml | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | PELLET / ORAL | 1140 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, EXTENDED RELEASE / ORAL | 5119 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CREAM / TOPICAL | NA | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 2000 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | LIQUID / ORAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SUSPENSION / ORAL | 1 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / ORAL | 980 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET / BUCCAL | 109 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CONCENTRATE / ORAL | NA | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | CAPSULE, EXTENDED RELEASE / ORAL | 53 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS | 900 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, DELAYED RELEASE PARTICLES / ORAL | 580 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTABLE, LIPOSOMAL / INTRAVENOUS | 7560 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, FILM COATED / ORAL | 145 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / SUBLINGUAL | 9 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / DENTAL | NA | ||
| SUCROSE | SUCROSE | C151H8M554 | DROPS / ORAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, SUGAR COATED / ORAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER / ORAL | 25 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 47 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, ORALLY DISINTEGRATING / ORAL | 184 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE, EXTENDED RELEASE / ORAL | 1246 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 615 mg | ||
| D&C RED NO. 27 | D&C RED NO. 27 | 2LRS185U6K | TABLET, EXTENDED RELEASE / ORAL | 1.43 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | EMULSION / TOPICAL | NA | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED / ORAL | 992 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | SUSPENSION / ORAL | 64 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION / SUBCUTANEOUS | 47.75 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, CHEWABLE / ORAL | 1725 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | SUSPENSION / ORAL | 1600 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SYRUP / ORAL | 0.05 mg/5ml | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE / ORAL | 2169 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, FOR SUSPENSION / ORAL | 1875 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | GRANULE / ORAL | 150 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | LOTION / TOPICAL | 80 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, COATED / ORAL | 0.52 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | AEROSOL, FOAM / VAGINAL | 4 %w/w | ||
| SUCROSE | SUCROSE | C151H8M554 | TROCHE / ORAL | NA | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | OINTMENT / TOPICAL | 15 %w/w | ||
| SUCROSE | SUCROSE | C151H8M554 | WAFER / ORAL | 155.2 mg |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 2ce2c8ea-3c41-f5fd-e063-6394a90a7de8 | f5c9e7ee-01a9-4b5c-a08b-b64570ba18f0 | 2025-01-29 | Warnings, Adverse reactions | 2ce2c8ea-3c41-f5fd-e063-6394a90a7de8 f5c9e7ee-01a9-4b5c-a08b-b64570ba18f0 |
Adverse event summaries are temporarily unavailable. Other product information remains available.