Fever consult adoctor before use.TESTS• DISSOLUTION30Medium: pH 5.8

Fever Relief Gummies for KidsACTIVE PHARMACEUTICAL INGREDIENT22,30AcetaminophenC8H9NO2 151.165Acetamide, N-(4-hydroxyphenyl);4c-Hydroxyacetanilide 103-90-2DEFINITIONAcetaminophen is an analgesic and antipyretic usedfor temporary relief of fever, minor aches, and pain.It contains NLT 98.0% and NMT 101.0% of C8H9NO2calculated on an anhydrous basis.PROPERTIES12,14,18,22,23,32• PHARMACOKINTIC PROPERTIESElimination half-life: 1-3 hours after doseMainly metabolized by liver• CHEMICAL PROPERTIESSolubility in water at 25°C: 14g/LDensity at 21°C: 1.293g/cm3Melting Point: 168°CpH: 6DOSAGE FORMType: Chewable tabletFunction: Fever relieverTotal Weight (per tablet): 1.675gPreparation: Melt granulation, compression15,25,31Shape: DiskFlavor: Lemon, sweetColor: Yellow, transparentSize: 1.5cm diameter, 1cm thicknessFORMULA (PER TABLET) 15Acetaminophen (API) 80mgGlucose syrup 600mgSucralose 400mgGelatin 300mgWater 150mgAnhydrous citric acid 50mgCarnauba Wax 40mgStarch 30mgD&C Yellow No. 10 25mgNote: The relative amounts for above ingredients is takenfrom Hull, P. (2010). Glucose Syrups: Technologies andApplications. Chichester, U.K.: Wiley-Blackwell Pub. Pages165-167, and has been modified to account for the activepharmaceutical ingredient, desired color, taste, and individualtablet size.DOSAGE REGIMEN26Age Weight(pounds) Dose4-11 months 12-17 1 tablet12-23 months 18-23 1.5 tablets2-3 years 24-35 2 tablets4-5 years 36-47 3 tablets6-8 years 48-59 4 tablets9-10 years 60-71 5 tablets11 years 72-95 6 tabletsNote: The chart above is taken from Temple A.R., TempleB.R., Kuffner E.K. Dosing and antipyretic efficacy of oralacetaminophen in children. ClinicalTherapeutics 2013; 35(9): 1361-1375.e45. and has beenrevised for this formula.Instructions: If possible, use weight to dose,otherwise, use age. Repeat dose every 4 hourswhile symptoms last. Do not exceed 5 doses in 1day. For children under 2 years of age, consult adoctor before use.TESTS• DISSOLUTION30Medium: pH 5.8 phosphate bufferApparatus 2: 75 rpmTime: 45 minutesProcedure: Determine amount of C8H9NO2dissolved using UV absorption at wavelengthof maximum absorbance (243 nm) on filteredportions of the solution under test, suitablydiluted with Dissolution Medium, if necessary.Tolerances: Not less than 75% of the labeledamount of C8H9NO2 is dissolved in 45 minutes.ADDITIONAL REQUIREMENTS• PACKAGING AND STORAGE: Package in tight, widemouth, light-resistant, multi-dose bottle withchild-resistant packaging. Store at controlledroom-temperature (20-25°C) and in a dry place.Protect product from excessive heat.22, 29, 30• LABELING: Chew tablet before swallowing. Keepout of