FDA.reportPublic FDA data

MultiVitamin with Fluoride Chewable Tablets

Manufacturer
H2-Pharma, LLC
Effective date
2025-09-16
Label type
DIETARY SUPPLEMENT
Version
2
Source
full-release
Hydrated at
2026-06-01 02:52:02

Label at a glance#

ProductMultiVitamin with Fluoride
Active ingredientVITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, SODIUM FLUORIDE
Label structure15 sections

Dosage and administration

One tablet daily or as directed by a physician.

Label contents#

Full prescribing information#

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

One tablet daily or as directed by a physician.

STATEMENT OF IDENTITY SECTION

Supplement Facts
Serving Size 1 Tablet
Servings Per Container 100
Amount Per Serving% Daily Value
Vitamin A750 mcg (2500 IU)83%
Vitamin C60 mg67%
Vitamin D10 mcg (400 IU)50%
Vitamin E6.75 mg (15 IU)45%
Thiamine1.05 mg88%
Riboflavin1.2 mg92%
Niacinamide13.5 mg84%
Vitamin B6 1.05 mg62%
Folate (Folic Acid)500 mcg DFE (0.3 mg)125%
Vitamin B12 4.5 mcg188%
Fluoride0.25 mg*        

* Daily Value not established

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.

HEALTH CLAIM SECTION

Other Ingredients: ascorbic acid, cholecalciferol, compressible sugar, cyanocobalamin, dl-alpha-tocopheryl acetate, FD&C Yellow #6 aluminum lake, folic acid, magnesium stearate, microcrystalline cellulose, natural and artificial orange flavor, niacinamide, polyethylene glycol, pyridoxine HCl, riboflavin, sodium ascorbate, sodium fluoride, stearic acid, sucralose, thiamine mononitrate and vitamin A acetate.

Active ingredient for caries prophylaxis: Fluoride as sodium fluoride.

CLINICAL PHARMACOLOGY

HEALTH CLAIM SECTION

Significant decrease in the incidence of dental caries can be linked to the fluoridation of the water supply (1ppm fluoride) during the period of tooth development.

MultiVitamin with Fluoride Chewable Tablets provide 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:

Ca10(PO4)6(OH2) + 2F-Ca10 (PO4)6F2 + 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 of saliva.

DIETARY SUPPLEMENTATION

HEALTH CLAIM SECTION

MultiVitamins with Fluoride Chewable Tablets offer supplementation of the diet with 10 vitamins and fluoride.

WARNINGS

WARNINGS SECTION

AS IN THE CASE OF ALL MEDICATIONS, KEEP OUT OF THE REACH OF CHILDREN. This tablet should be chewed. This product, as with all chewable tablets, are not recommended for children under the age of 4 due to risk of choking.

PRECAUTIONS

PRECAUTIONS SECTION

The suggested dose of MultiVitamin with Fluoride Chewable Tablets should not be exceeded, since dental fluorosis may result from continued ingestion of large amounts of fluoride.

Before recommending MultiVitamin with 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.

ADVERSE REACTIONS

HEALTH CLAIM SECTION

Allergic rash and other idiosyncrasies have been rarely reported.

To report SUSPECTED ADVERSE REACTIONS, contact H2-Pharma, LLC at 1 (866) 592-6438 or FDA at 1 (800) 332-1088 or via the web at www.fda.gov/medwatch/index.html for voluntary reporting of adverse reactions.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

One tablet daily or as directed by a physician.

HOW SUPPLIED

HEALTH CLAIM SECTION

MultiVitamin with Fluoride Chewable Tablets 0.25 mg are available as orange chewable tablets imprinted with "155" in 100 tablet bottles.

MultiVitamin with Fluoride Chewable Tablets 0.5 mg are available as orange chewable tablets imprinted with "156" in 100 tablet bottles.

MultiVitamin with Fluoride Chewable Tablets 1.0 mg are available as orange chewable tablets imprinted with "157" in 100 tablet bottles.

STORAGE

HEALTH CLAIM SECTION

Store at controlled room temperature 20°C-25°C (68°-77°F), excursions permitted between 15°-30°C (59°-86°F) [See USP].

Tamper Evident

SAFE HANDLING WARNING SECTION

Do not use if seal under cap is torn, broken or missing.

HEALTH CLAIM SECTION

Distributed by:
H2-Pharma, LLC
Montgomery, AL 36117

PRINCIPAL DISPLAY PANEL - 0.25 mg Tablet Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

61269-155-01

MultiVitamin
with Fluoride
Chewable Tablets

0.25 mg

MultiVitamin and Fluoride Supplement

Dietary Supplement
Orange Flavor

100 Tablets

H2 pharma

PRINCIPAL DISPLAY PANEL - 0.25 mg Tablet Bottle Label
PRINCIPAL DISPLAY PANEL - 0.25 mg Tablet Bottle Label

PRINCIPAL DISPLAY PANEL - 0.5 mg Tablet Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

61269-156-01

MultiVitamin
with Fluoride
Chewable Tablets

0.5 mg

MultiVitamin and Fluoride Supplement

Dietary Supplement
Orange Flavor

100 Tablets

H2 pharma

PRINCIPAL DISPLAY PANEL - 0.5 mg Tablet Bottle Label
PRINCIPAL DISPLAY PANEL - 0.5 mg Tablet Bottle Label

PRINCIPAL DISPLAY PANEL - 1 mg Tablet Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

61269-157-01

MultiVitamin
with Fluoride
Chewable Tablets

1 mg

MultiVitamin and Fluoride Supplement

Dietary Supplement
Orange Flavor

100 Tablets

H2 pharma

PRINCIPAL DISPLAY PANEL - 1 mg Tablet Bottle Label
PRINCIPAL DISPLAY PANEL - 1 mg Tablet Bottle Label

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASCORBIC ACID Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CHOLECALCIFEROL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CYANOCOBALAMIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PYRIDOXINE Pharmacologic Class Indexing1Indexing - Pharmacologic Class20170310
VITAMIN A Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cf050ccd-1144-f76a-e00d-e5698d8597d4Product name620250625
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61269-155-01MultiVitamin with Fluoride100 in 1 BOTTLETABLET, CHEWABLE1002
61269-156-01MultiVitamin with Fluoride100 in 1 BOTTLETABLET, CHEWABLE1002
61269-157-01MultiVitamin with Fluoride100 in 1 BOTTLETABLET, CHEWABLE1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61269-155-01EA - Each61269-1551941e63e-9497-491a-9afe-a54511f4686012022-11-07
61269-156-01EA - Each61269-1566d1e5f16-f7ab-4f2c-b639-cf5b550f335212022-11-07
61269-157-01EA - Each61269-1576b51926c-7412-4002-b14a-dd28e1676eed12022-11-07

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61269-15561269-155-01
61269-15661269-156-01
61269-15761269-157-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 57 matching rows.

Name, UNII, Kind table
NameUNIIKind
VITAMIN A ACETATE3LE3D9D6OYACTIM
ASCORBIC ACIDPQ6CK8PD0RACTIB
CHOLECALCIFEROL1C6V77QF41ACTIB
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8ACTIM
THIAMINE MONONITRATE8K0I04919XACTIR
RIBOFLAVINTLM2976OFRACTIB
NIACINAMIDE25X51I8RD4ACTIB
PYRIDOXINE HYDROCHLORIDE68Y4CF58BVACTIB
FOLIC ACID935E97BOY8ACTIB
CYANOCOBALAMINP6YC3EG204ACTIB
SODIUM FLUORIDE8ZYQ1474W7ACTIB
SUCROSEC151H8M554IACT
FD&C YELLOW NO. 6H77VEI93A8IACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
SODIUM ASCORBATES033EH8359IACT
STEARIC ACID4ELV7Z65APIACT
SUCRALOSE96K6UQ3ZD4IACT
VITAMIN A ACETATE3LE3D9D6OYACTIM
ASCORBIC ACIDPQ6CK8PD0RACTIB
CHOLECALCIFEROL1C6V77QF41ACTIB
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8ACTIM
THIAMINE MONONITRATE8K0I04919XACTIR
RIBOFLAVINTLM2976OFRACTIB
NIACINAMIDE25X51I8RD4ACTIB
PYRIDOXINE HYDROCHLORIDE68Y4CF58BVACTIB
FOLIC ACID935E97BOY8ACTIB
CYANOCOBALAMINP6YC3EG204ACTIB
SODIUM FLUORIDE8ZYQ1474W7ACTIB
SUCROSEC151H8M554IACT
FD&C YELLOW NO. 6H77VEI93A8IACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
SODIUM ASCORBATES033EH8359IACT
STEARIC ACID4ELV7Z65APIACT
SUCRALOSE96K6UQ3ZD4IACT
VITAMIN A ACETATE3LE3D9D6OYACTIM
ASCORBIC ACIDPQ6CK8PD0RACTIB

Source Document#

Source XML

openFDA label cross-check#

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.

Matched openFDA labels page 1 of 1 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Multivitamin with Fluoride.ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A AND VITAMIN DBryant Ranch Prepack696cb342-fc5c-47cf-bbc8-5ecc706074c02026-03-27Warnings, Adverse reactionsName fallback
brand name: Multivitamin with Fluoride
Multivitamin with Fluoride.ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A AND VITAMIN DBryant Ranch Prepack0800f4ef-1d98-4c0f-a016-501791973f662026-03-27Warnings, Adverse reactionsName fallback
brand name: Multivitamin with Fluoride
Multivitamin with Fluoride.ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A AND VITAMIN DBryant Ranch Prepack0f11c8c7-c73e-4610-83ed-e697539ac1802026-03-27Warnings, Adverse reactionsName fallback
brand name: Multivitamin with Fluoride
Multivitamin with Fluoride.ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A AND VITAMIN DBryant Ranch Prepackf28c8928-81c3-458a-9ce2-2aaca3b7527d2026-03-18Warnings, Adverse reactionsName fallback
brand name: Multivitamin with Fluoride
Multivitamin with Fluoride.ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A AND VITAMIN DBryant Ranch Prepackef79cadb-c553-4af1-9a53-6ea1ab26b4bb2026-03-18Warnings, Adverse reactionsName fallback
brand name: Multivitamin with Fluoride
Multivitamin with Fluoride.ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A AND VITAMIN DBryant Ranch Prepack6607fcec-2da9-47df-ad92-1d545f7bf5352026-03-17Warnings, Adverse reactionsName fallback
brand name: Multivitamin with Fluoride
Multivitamin with Fluoride.ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A AND VITAMIN DBryant Ranch Prepack3c3acbdd-0bcb-4798-b6c5-242bdcd352b12026-03-17Warnings, Adverse reactionsName fallback
brand name: Multivitamin with Fluoride
Multivitamin with Fluoride.ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A AND VITAMIN DBryant Ranch Prepack5568579f-3445-4f04-a936-33c78b33392c2026-03-17Warnings, Adverse reactionsName fallback
brand name: Multivitamin with Fluoride
Multivitamin with Fluoride.ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A AND VITAMIN DBryant Ranch Prepackb7f1c321-5a00-4b89-8cb4-fa250e74d9db2026-03-17Warnings, Adverse reactionsName fallback
brand name: Multivitamin with Fluoride
Multivitamin with Fluoride.ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A AND VITAMIN DMethod Pharmaceuticals, LLC42ed15a5-aad6-4ab3-b95b-f9534a419f402025-10-21Warnings, Adverse reactionsName fallback
brand name: Multivitamin with Fluoride
Multivitamin with Fluoride.ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A AND VITAMIN DMethod Pharmaceuticals, LLC71698332-4ab1-4cbb-a98d-1694b715924b2025-10-21Warnings, Adverse reactionsName fallback
brand name: Multivitamin with Fluoride
Multivitamin with Fluoride.ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A AND VITAMIN DMethod Pharmaceuticals, LLCa5af0d8e-5d83-40bb-8df5-3af7277d72cf2025-10-21Warnings, Adverse reactionsName fallback
brand name: Multivitamin with Fluoride
Multivitamin with FluorideSODIUM FLUORIDEWINDER LABORATORIES, LLCa10ff759-eba7-414b-bb98-f17fbb6e6b572025-08-27Warnings, Adverse reactionsName fallback
brand name: Multivitamin with Fluoride

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.