PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.


PRINCIPAL DISPLAY PANEL NDC 58657-325-50 Multi- Vitamin Drops With Fluoride 0.25 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-VitaminDropswithFluoride0.25mgalsoprovidesfluorideforcariesprophylaxis. 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-VitaminDropswithFluoride0.25mgsupplysignificant 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 andFluoride0.25mgdropsisavailablein50mLbottleswithaccompanyingcalibrateddropper.

PRECAUTIONS SECTION.


PRECAUTIONS Thesuggesteddoseshouldnotbeexceededsincedentalfluorosismayresultfromcontinuedingestionoflargeamountsoffluoride. Whenprescribingvitaminfluorideproducts: Determinethefluoridecontentofthedrinkingwater. Makesurethechildisnotreceivingsignificantamountsoffluoridefromothermedicationsandswallowedtoothpaste. Periodicallychecktomakesurethatthechilddoesnotdevelopsignificantdentalfluorosis. Multi-Vitamin Drops with Fluoride 0.25 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.) ImportantConsiderationsWhenUsingDosageSchedule: Iffluoridelevelisunknown,drinkingwatershouldbetested forfluoridecontentbeforesupplementsareprescribed.Fortestingoffluoridecontent,contactthelocalorstatehealthdepartment. Allsourcesoffluorideshouldbeevaluatedwithathoroughfluoridehistory.Patientexposuretomultiplewatersourcescanmakeproperprescribingcomplex. Ingestionofhigherthanrecommendedlevelsoffluoridebychildrenhasbeenassociatedwithanincreaseinmilddentalfluorosisindeveloping,uneruptedteeth. Fluoridesupplementsrequirelong-termcomplianceonadailybasis.

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, Pediatrics1986;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: 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 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.