Epiflur

Each Epiflur™ (sodium fluoride) Tablet is sugar free, saccharine free and erythrosine (FD&C Red Dye #3) free. Each Epiflur™ Tablet 1 mg F* (full-strength) contains 1 mg fluoride ion (F*) from 2.2 mg sodium fluoride (NaF). Each Epiflur™ Tablet 0.5 mg (half-strength) contains 0.5 mg F* from 1.1 mg sodium fluoride (NaF). Each Epiflur™ Tablet 0.25 mg (quarter-strength) contains 0.25 mg F* from 0.55 mg sodium fluoride (NaF).

Each tablet for oral administration contains sodium fluoride equivalent to fluoride 0.25 mg, 0.5 mg or 1 mg and the following inactive ingredients: microcrystalline cellulose, maltodextrin, sorbitol, colloidal silicon dioxide, natural and artificial vanilla flavored powder and magnesium stearate. In addition, the 0.5 mg tablet contains purple lake blend and the 1 mg tablet contains pink lake blend.

Sodium fluoride acts systemically (before tooth eruption) and topically (post eruption) by increasing tooth resistance to acid dissolution, by promoting remineralization, and by inhibiting the cariogenic microbial process.

Prolonged daily ingestion of quantities greater than the recommended amount may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially if the water fluoridation exceeds 0.6 ppm. Read directions carefully before using. Keep out of the reach of infants and children.

Allergic rash and other idiosyncrasies have been rarely reported.

Accidental ingestion of large amounts of fluoride may result in acute burning in the mouth and sore tongue. Nausea, vomiting, and diarrhea may occur soon after ingestion (within 30 minutes) and are accompanied by salivation, hematemesis, and epigastric cramping abdominal pain. These symptoms may persist for 24 hours. If less than 5 mg fluoride/kg body weight (i.e. less than 2.3 mg fluoride/lb body weight) has been ingested, give calcium (e.g., milk) orally to relieve gastrointestinal symptoms and observe for a few hours. If more than 5 mg fluoride/kg body weight (i.e. more than 2.3 mg fluoride/lb body weight) has been ingested, induce vomiting, give orally soluble calcium (e.g. milk, 5% calcium gluconate or calcium lactate solution) and immediately seek medical assistance. For accidental ingestion of more than 15 mg fluoride/kg of body weight (i.e. more than 6.9 mg fluoride/lb body weight), induce vomiting and admit immediately to a hospital facility.

A treatment dose of Epiflur™ Tablets contains 0.25, 0.5 or 1 mg fluoride. The treatment of choice depends upon the age of the child and the water fluoride content. A bottle of 120 0.25 mg tablets contains 30 mg fluoride. A bottle of 120 0.5 mg tablets contains 60 mg fluoride. A bottle of 120 1 mg tablets contains 120 mg fluoride. [The total amount of sodium fluoride in a bottle of 120 Epiflur™ Tablets (all strengths) conforms with the recommendations of the American Dental Association for the maximum to be dispensed at one time for safety purposes.]

Epiflur™ (sodium fluoride) Tablets, 0. 25 mg F* (equivalent to 0.25 mg of fluoride) are white, round, biconvex tablets debossed “Є 37” available in bottles of 120’s and 1000’s.

Epiflur™ (sodium fluoride) Tablets, 0. 5 mg F* (equivalent to 0.5 mg of fluoride) are purple, round, biconvex tablets debossed “Є 60” available in bottles of 120’s and 1000’s.

Epiflur™ (sodium fluoride) Tablets, 1 mg F* (equivalent to 1mg of fluoride) are pink, round, biconvex tablets debossed “Є 73” available in bottles of 120’s and 1000’s.

1. Accepted Dental Therapeutics, Ed. 40, American Dental Association, Chicago, 399-402 (1984).
2. J. Jakush, New Fluoride Schedule Adopted, ADA News, 12, 14 (May 16, 1994
3. Aasenden, R., and Peebles, T.C. “Effects of Fluoride Supplementation From Birth on Dental Caries and Fluorosis in Teenaged Children", Arch. Oral Biol. 23, 111-115 (1974).
4. Hamberg, L. “Controlled Trial of Fluoride Vitamin Drops for Prevention of Caries in Children”, Lancet, 1, 441-442 (1971).
5. Hennon, D.K. Stookey, G.K. and Beiswanger, B.B. “Fluoride-Vitamin Supplements:

Effects on Dental Caries and Fluorosis When Used in Areas with Suboptimum Fluoride in

the Water Supply”, JADA, 95, 965-971 (1977).

Manufactured by:

Epic Pharma, LLC

Laurelton, NY 11413

Issued 6/09

MF037ISS0609

OE1014

MG #27933 (01)

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very upset stomach or throwing up.