MULTIVITAMIN WITH FLUORIDE- .alpha.-tocopherol acetate, dl-, ascorbic acid, cyanocobalamin, folic acid, niacin, pyridoxine, ribo

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

VITAMIN A (UNII: 81G40H8B0T) (VITAMIN A - UNII:81G40H8B0T), ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R), VITAMIN D (UNII: 9VU1KI44GP) (VITAMIN D - UNII:9VU1KI44GP), .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01), THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J), RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR), NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A), PYRIDOXINE (UNII: KV2JZ1BI6Z)

Available from:

Bryant Ranch Prepack

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Supplementation of the diet with ten essential vitamins. Supplementation of the diet with fluoride for caries prophylaxis. M ultivitamin with Fluoride 0.5 mg Chewable Tablets provide 0.5 mg fluoride in tablet form for children 4-6 years of age in areas where the drinking water fluoride level is less than 0.3 ppm, and for children 6 years of age and above where the drinking water contains 0.3 through 0.6 ppm of fluoride. Multivitamin with Fluoride 0.5 mg Chewable Tablets supply 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.  Thus, in a single easy-to-use preparation, children obtain ten essential vitamins and the important mineral, fluoride. 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. Children usi

Product summary:

Multivitamin Chewable tablets containing 0.5 mg fluoride are round yellowish/cream tablets with orange and yellow speckles. Debossed with “M164” on one side. NDC: 63629-1137-1 (90 count)

Authorization status:

unapproved drug other

Summary of Product characteristics

MULTIVITAMIN WITH FLUORIDE- .ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC
ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN,
SODIUM FLUORIDE,
THIAMINE MONONITRATE, VITAMIN A AND VITAMIN D TABLET, CHEWABLE
BRYANT RANCH PREPACK
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this_
_labeling has not been approved by FDA. For further information about
unapproved_
_drugs, click here._
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MULTIVITAMIN WITH FLUORIDE 0_5 MG
MULTIVITAMIN WITH FLUORIDE
_Disclaimer: This drug has not been found by FDA to be safeand
effective, and this_
_labeling has not been approved by FDA._
PRESCRIBING INFORMATION
EACH FLUORIDE CHEWABLE TABLET CONTAINS:
SUPPLEMENT FACTS
Dosage Size 1 Chewable Tablet
AMOUNT PER TABLET
% DV ADULTS AND
CHILDREN
4 YEARS OR MORE
Vitamin A (as Vitamin A
acetate)
2500 IU
50%
Vitamin C (as ascorbic
acid)
60 mg
100%
Vitamin D (as
cholecalciferol)
400 IU
100%
Vitamin E (dl-alpha
tocopherol acetate)
15 IU
50%
Thiamine (as thiamine)
1.05 mg
70%
Riboflavin (as riboflavin)
1.2 mg
71%
Niacin (as niacinamide)
13.5 mg
68%
Vitamin B6 (as pyridoxine
HCl)
1.05 mg
53%
Folate (as folic acid)
300 mcg
75%
Vitamin B12 (as
cyanocobalamin)
4.5 mcg
75%
Fluoride (as sodium
fluoride)
0.5 mg
*
*Daily value (DV) not established
MULTIVITAMIN WITH FLUORIDE 0.5 MG CHEWABLE TABLETSACTIVE INGREDIENT
FOR
CARIES PROPHYLAXIS: Fluoride as sodium fluoride
MULTIVITAMIN WITH FLUORIDE 0.5 MG CHEWABLE TABLETSprovide sodium
fluoride and
ten essential vitamins in a chewable tablet.
OTHER INGREDIENTS: citric acid, magnesium stearate, mannitol,
microcrystalline
cellulose, orange flavor, sucralose, talc, xylitol.
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.
MULTIVITAMIN WITH FLUORIDE 0.5 MG CHEWABLE TABLETSprovide sodium
fluoride and
ten essential vitamins in a chewable tablet. Because the tablets are
chewable,
they provide a _topical _as well as _