Multi-Vitamin description, usages, side effects, indications, overdosage, supplying and lots more!

Multi-Vitamin

Boca Pharmacal, Inc
Boca Pharmacal, Inc

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert



FULL PRESCRIBING INFORMATION

*Daily Value not established
Supplement Facts
Serving Size: 1 Chewable Tablet
Amount Per Tablet % Daily Value Adults & children 4 years or more
Vitamin A ................................. 2500 IU 50%
Vitamin C ................................... 60 mg 100%
Vitamin D .................................. 400 IU 100%
Vitamin E .................................... 15 IU 50%
Thiamin (B1) .......................... 1.05 mg 70%
Riboflavin (B2) ......................... 1.2 mg 71%
Niacin ..................................... 13.5 mg 68%
Vitamin (B6) ........................... 1.05 mg 53%
Folate ........................................ 0.3 mg 75%
Vitamin B12 ............................ 4.5 mcg 75%
Fluoride (as sodium fluoride) ... 1.0 mg *

Active ingredient for Caries Prophylaxis: Fluoride as Sodium Fluoride.

Other ingredients: Artificial grape flavor, ascorbic acid, butylated hydroxyl toluene, cholecalciferol, citric acid, compressible sugar, DL-alpha Tocopherol, D&C Red # 7 calcium lake, FD&C Blue #1 aluminum lake, folic acid, gelatin, magnesium stearate, maltodextrin, mannitol, medium chain triglycerides, methyl cellulose, mono- and di-glycerides, niacinamide, povidone, pyridoxine, riboflavin, silicon dioxide, sodium ascorbate, sodium citrate, starches, sucralose, thiamine, vitamin A acetate, vitamin B12 and vitamin E acetate.

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.

Multi-vitamin 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(OH)2 + 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 from saliva.

Supplementation of the diet with ten essential vitamins.

Supplementation of the diet with fluoride for caries prophylaxis.

See Dosage and Administration.

Multi-vitamin with Fluoride Chewable Tablets supply significant amounts of Vitamins A, C, D, E, thiamin, 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 supplementation.

Children using Multi-vitamin with fluoride Chewable Tablets regularly should receive semiannual dental examinations. The regular brushing of teeth and attention to good oral hygiene practices are also essential.

As in the case of all medications, keep out of the reach of children.

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 Multi-vitamin with Fluoride Chewable Tablets should not be exceeded, since dental fluorosis may result from continued ingestion of large amounts of fluoride.

Before prescribing Multi-vitamin with Fluoride Chewable Tablets, read these Important Considerations When Using Dosage Schedule found in Dosage and Administration .

  • If fluoride level is unknown, drinking water should be tested for fluoride content before supplements are prescribed. For testing of fluoride content, contact the local or state health department.
  • All sources of fluoride should be evaluated with a thorough fluoride history.
  • Patient exposure to multiple water sources can make proper prescribing complex.
  • Ingestion of higher than recommended levels of fluoride by children has been associated with an increase in mild dental fluorosis in developing, unerupted teeth.
  • Fluoride supplements require long-term compliance on a daily basis.

Allergic rash and other idiosyncrasies have been rarely reported.

*1.0 ppm = 1 mg / liter
**2.2 mg Sodium Fluoride contains 1mg fluoride ion.
Fluoride Ion Level in Drinking Water (ppm)*
AGE <0.3 ppm 0.3-0.6 ppm >0.6 ppm
4-6 years 0.50 mg / day**
(1/2 tablet)
0.25 mg / day
(1/4 tablet)
None
6-16 years 1.0 mg / day
(1 tablet)
0.50 mg / day
(1/2 tablet)
None

Multi-vitamin 1 mg Sodium Fluoride Tablets: grape flavored, round, purple, debossed “BP 815”, available in 100 ct. bottle, NDC 64376-815-01.

Multi-vitamin 0.5 mg Sodium Fluoride Tablets: cherry flavored, square, red, debossed “BP 814”, available in 100 ct. bottle, NDC 64376-814-01.

Multi-vitamin 0.25 mg Sodium Fluoride Tablets: orange flavored, round, orange, debossed “BP 813”, available in 100 ct. bottle, NDC 64376-813-01.

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C -30°C (59°-86°F) [See USP Controlled Room Temperature].

Manufactured for:
Boca Pharmacal, Inc.
Coral Springs, FL 33065
www.bocapharmacal.com
1-800-354-8460 Iss. 07/11

[Rev 13]

Multi-Vitamin

Vitamin A, Vitamin D, Thiamine, Riboflavin, Niacin, Pyridoxine, Folic Acid, Fluoride Ion, Ascorbic Acid, Alpha-Tocopherol-Acetate-DL, Cyanocobalamin TABLET, CHEWABLE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:64376-815
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
VITAMIN A 2500 [iU]
Vitamin D 400 [iU]
Thiamine 1.05 mg
RIBOFLAVIN RIBOFLAVIN 1.2 mg
NIACIN 13.5 mg
PYRIDOXINE 1.05 mg
FOLIC ACID FOLIC ACID 0.3 mg
FLUORIDE ION FLUORIDE ION 1.0 mg
ASCORBIC ACID ASCORBIC ACID 60 mg
.ALPHA.-TOCOPHEROL ACETATE, DL- .ALPHA.-TOCOPHEROL, DL- 15 [iU]
Cyanocobalamin CYANOCOBALAMIN 4.5 ug

Inactive Ingredients

Ingredient Name Strength
SODIUM CITRATE
CHOLECALCIFEROL
Cyanocobalamin
FD&C BLUE NO. 1
FOLIC ACID
GELATIN
STARCH, CORN
MAGNESIUM STEARATE
mannitol
NIACINAMIDE
povidone
PYRIDOXINE
GRAPE
RIBOFLAVIN
SILICON DIOXIDE
sodium ascorbate
Thiamine
VITAMIN A ACETATE
ALPHA-TOCOPHEROL ACETATE
D&C RED NO. 7
ASCORBIC ACID
Sucralose
BUTYLATED HYDROXYTOLUENE
CITRIC ACID MONOHYDRATE
.ALPHA.-TOCOPHEROL, DL-
maltodextrin
MEDIUM-CHAIN TRIGLYCERIDES
SUCROSE
GLYCERYL MONOSTEARATE
METHYLCELLULOSE (1500 CPS)

Product Characteristics

Color Size Imprint Code Shape
PURPLE 13 mm BP;815 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:64376-815-01 100 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2011-09-06


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