HOW SUPPLIED SECTION.


HOW SUPPLIED Multi-Vitamin andFluoride0.5 mgdropsisavailablein50mLbottleswithaccompanyingcalibrateddropper.

PRECAUTIONS SECTION.


PRECAUTIONS Thesuggesteddoseshouldnotbeexceededsincedentalfluorosismayresultfromcontinuedingestionoflargeamountsoffluoride. Whenprescribingvitaminfluorideproducts: Determinethefluoridecontentofthedrinkingwater. Makesurethechildisnotreceivingsignificantamountsoffluoridefromothermedicationsandswallowedtoothpaste. Periodicallychecktomakesurethatthechilddoesnotdevelopsignificantdentalfluorosis. Multi-Vitamin Drops with Fluoride 0.5 mg should be dispensed in the original plastic container, since contact with glass leads to instability and precipitation. (The amount of sodium fluoride in the 50 mL size is well below the maximum to be dispensed at one time according to recommendations of the American Dental Association.) Important Considerations When Using Dosage Schedule: 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 anincrease in mild dental fluorosis in developing, unerupted teeth. Fluoride supplements require long-term compliance on a daily basis.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.


PRINCIPAL DISPLAY PANEL NDC 58657-326-50 Multi- Vitamin Drops With Fluoride 0.5 mg 1.69 FL. OZ. (50 mL)

ADVERSE REACTIONS SECTION.


ADVERSE REACTIONS Allergic rash and other idiosyncrasies have been rarely reported.

INDICATIONS & USAGE SECTION.


INDICATIONS AND USAGE SupplementationofthedietwithvitaminsA,CandD. Multi-VitaminDropswithFluoride0.5 mgalsoprovidesfluorideforcariesprophylaxis. TheAmericanAcademyofPediatricsrecommendsthatchildrenuptoage16,inareaswheredrinkingwatercontainslessthanoptimallevelsoffluoride,receivedailyfluoridesupplementation. The American Academy of Pediatrics recommend that infants and young children 6 months to 3 years of age, in areas where the drinking water contains less than 0.3 ppm of fluoride, and children 3-6 years of age, in areas where the drinking water contains 0.3 through 0.6 ppm of fluoride, receive 0.5 mg of supplemental fluoride daily which is provided in a dose of 1 mL of Multi-Vitamin Drops with Fluoride 0.5 mg (See Dosage and Administration ). Multi-VitaminDropswithFluoride0.5 mgsupplysignificant amountsofvitaminsA,CandDtosupplementthediet,andtohelpassurethatnutritionaldeficienciesofthesevitaminswillnotdevelop. Thus,inasingleeasy-to-usepreparation,childrenobtainessentialvitaminsandfluoride.

DOSAGE & ADMINISTRATION SECTION.


DOSAGE AND ADMINISTRATION: See following chart. May be dropped directly into the mouth with dropper; or mixed with cereal, fruit juice or other food. Fluoride Ion Level in Drinking Water (ppm) * A g e 0.6 ppm Birth-6months None None None 6mos-3years 0.25mg(1mL)/day None None 3-6years 0.50mg(2mL) /day 0.25mg(1mL)/day None * 1.0 ppm=1mg/liter 2.2 mgsodiumfluoridecontains1mgfluorideion.

SPL UNCLASSIFIED SECTION.


RECOMMENDED STORAGE Storeatcontrolledroomtemperature15-25C(between59Fand77F).ExcursionsPermitted.Afteropeningstoreawayfromdirect light.Closetightlyaftereachuse.Occasionaldeepeningofcolorhasnosignificanteffect on vitaminpotency. REFRIGERATIONISNOTREQUIRED. SHAKEWELL.

REFERENCES SECTION.


REFERENCES BrudevoidF,McCannHG:Fluorideandcariescontrol-Mechanismofaction,inNizelAE(ed): The Science of Nutrition and its Application in Clinical Dentistry. Philadelphia,WBSaundersCo,1966, pp331-347. AmericanAcademyofPediatricsCommitteeonNutrition:Fluoridesupplementation, Pediatrics 1986;77:758. AmericanDentalAssociationCouncilonDentalTherapeutics: Accepted Dental Therapeutics,ed38,Chicago,1979,p321. HennonDK,StookeyGK,MuhlerJC: Theclinicalanticariogeniceffectivenessofsupplementaryfluoride-vitaminpreparations-Resultsattheendofthreeyears. J Dent Children 1966;33January:3-12. HennonDK,StookeyGK,MuhlerJC: Theclinicalanticariogeniceffectivenessofsupplementaryfluoride-vitaminpreparations-Resultsattheendoffouryears. J Dent Children 1967;34November; 439-443. HennonDK,StookeyGK,MuhlerJC: Theclinicalanticariogeniceffectivenessofsupplementary fluoride-vitaminpreparations-Resultsattheendoffiveandahalfyears. Phar and Ther in Dent 1970;1:1. HennonDK,StookeyGK,BeiswangerBB:Fluoride-vitaminsupplements:Effectsondentalcariesandfluorosiswhenusedinareaswith suboptimumfluorideinthewatersupply. J Am Dent Assoc 1977;95-965 Distributed by: Method Pharmaceuticals, LLC Fort Worth, TX 76118 877-250-3427 Rev.01/17 MadeintheUSA

CLINICAL PHARMACOLOGY SECTION.


CLINICAL PHARMACOLOGY Itiswellestablishedthatfluoridationofthewatersupply(1ppmfluoride)duringtheperiodoftoothdevelopment leadstoasignificantdecreaseintheincidenceofdentalcaries. Hydroxyapatiteistheprincipalcrystalforallcalcifiedtissueinthehumanbody.Thefluorideionreactswithhydroxyapatiteinthetoothasitisformedtoproducethemorecaries-resistantcrystal,fluorapatite. Thereactionmaybeexpressedbytheequation: Threestagesoffluoridedepositionintoothenamelcanbedistinguished: Smallamounts(reflectingthelowlevelsoffluorideintissuefluids)areincorporatedintotheenamelcrystalswhiletheyarebeingformed. Afterenamelhasbeenlaiddown,fluoridedepositioncontinuesinthesurfaceenamel.Diffusionoffluoridefromthesurfaceinwardisapparentlyrestricted. Aftereruption,thesurfaceenamelacquiresfluoridefromwater,food,supplementaryfluorideandsmalleramountsfromsaliva.

WARNINGS SECTION.


WARNINGS Asinthecaseofallmedications,keepoutofreachofchildren.