PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.


PRINCIPAL DISPLAY PANEL NDC 58657-327-50 Multi- Vitamin Drops With Fluoride & Iron 0.25 mg 1.69 FL. OZ. (50 mL) Rx Only

ADVERSE REACTIONS SECTION.


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

INDICATIONS & USAGE SECTION.


INDICATIONS AND USAGE SupplementationofthedietwithvitaminsA,CandD. Multi-VitaminDropswithFluoride and Iron0.25mgalsoprovidesfluorideforcariesprophylaxis. 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 0.25 mg of supplemental fluoride daily which is provided in a dose of 1 mL of Multi-Vitamin Drops with Fluoride 0.25 mg (See Dosage and Administration ). Multi-VitaminDropswithFluoride and Iron0.25mgsupplysignificant 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.

HOW SUPPLIED SECTION.


HOW SUPPLIED Multi-Vitamin andFluoride and Iron0.25mgdropsisavailablein50mLbottleswithaccompanyingcalibrateddropper.

PRECAUTIONS SECTION.


PRECAUTION S Thesuggesteddoseshouldnotbeexceededsincedentalfluorosismayresultfromcontinuedingestionoflargeamountsoffluoride. Whenprescribingvitaminfluorideproducts: Determinethefluoridecontentofthedrinkingwater. Makesurethechildisnotreceivingsignificantamountsoffluoridefromothermedicationsandswallowedtoothpaste. Periodicallychecktomakesurethatthechilddoesnotdevelopsignificantdentalfluorosis. Multi-VitaminDropswithFluorideIron 0.25mgshouldbedispensedintheoriginalplasticcontainer,sincecontact withglassleadstoinstabilityandprecipitation.(Theamountofsodiumfluorideinthe50mLsizeiswellbelowthemaximumtobedispensedat onetimeaccordingtorecommendationsoftheAmericanDentalAssociation.) ImportantConsiderationsWhenUsingDosageSchedule: Iffluoridelevelisunknown,drinkingwatershouldbetested forfluoridecontentbeforesupplementsareprescribed.Fortestingoffluoridecontent,contactthelocalorstatehealthdepartment. Allsourcesoffluorideshouldbeevaluatedwithathoroughfluoridehistory.Patientexposuretomultiplewatersourcescanmakeproperprescribingcomplex. Ingestionofhigherthanrecommendedlevelsoffluoridebychildrenhasbeenassociatedwithanincreaseinmilddentalfluorosisindeveloping,uneruptedteeth. Fluoridesupplementsrequirelong-termcomplianceonadailybasis.

REFERENCES SECTION.


R E F E R E NC E S BrudevoidF,McCannHG:Fluorideandcariescontrol-Mechanismofaction,inNizelAE(ed): The Science of Nutrition and its Application in Clinical Dentistry. Philadelphia,WBSaundersCo,1966, pp331-347. AmericanAcademyofPediatricsCommitteeonNutrition:Fluoridesupplementation, Pediatrics 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: Theclinicalanticariogeniceffectivenessofsupplementaryfluoride-vitaminpreparations-Resultsattheendoffiveandahalfyears. Phar and Ther in Dent 1970;1:1. HennonDK,StookeyGK,BeiswangerBB:Fluoride-vitaminsupplements:Effectsondentalcariesandfluorosiswhenusedinareaswith suboptimumfluorideinthewatersupply. J Am Dent Assoc 1977;95-965 1986;77:758. 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.


WARNING S Asinthecaseofallmedications,keepoutofreachofchildren.