Drug Label Analysis of Allegra Tablets

Allegra is a product of Aventis Pharmaceuticals Inc. The active ingredient in Allegra is fexofenadine hydrochloride and the other compounds listed are excipients used to make the tablets.

Fexofenadine Hydrochloride
Croscarmellose Sodium
Other Names()-4-[1-hydroxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]-butyl]-alpha,alpha-dimethyl benzeneacetic acid hydrochloride Other NamesEdifas B; Sodium carboxymethyl cellulose
Molecular FormulaC32H40ClNO4 Molecular FormulaC28H30Na8O27
CAS #138452-21-8 CAS #9004-32-4
NOWRAP>Molecular Weight (g)538.1253 Molecular Weight (g)982.4470
Physical State & AppearanceWhite to off white powder Physical State & AppearanceWhite to off white powder
Melting Point (ºC)Unavailable Melting Point (ºC)>300
Boiling Point (ºC)Unavailable Boiling Point (ºC)>300
Density (g/mL)Unavailable Density (g/mL).75
Solubility in WaterSlight Solubility in WaterSlight to soluble
Other SolubilitiesFreely soluble in methanol and ethanol, slightly soluble in chloroform, insoluble in hexane Other SolubilitiesInsoluble in organic liquids
OriginSynthetic OriginSynthetic
Method of IsolationMetabolism of terfenadine Method of IsolationManufactured from cellulose which has been processed to have a high affinity for water.
Intended FunctionAntihistamine with selective peripheral H1-receptor antagonist activity. Intended FunctionDissolution accelerator--a "super" disintegrant because it is very effective even at low concentrations at promoting the breakdown of tablets following ingestion.
Magnesium Stearate
Microcrystalline Cellulose
Other NamesOctadecanoic Acid; Magnesium Salt Other NamesMCC; Cellulose
Molecular FormulaC36H70MgO4 Molecular Formula(C6H10O5)n
CAS #557-04-0 CAS #9004-34-6
Molecular Weight (g)591.2516 Molecular Weight (g)160,000-560,000
Physical State & AppearanceFine, white to yellow-white powder Physical State & AppearanceFine, white to off white, crystalline powder
Melting Point (ºC)150-170 Melting Point (ºC)Varies depending on molecular weight
Boiling Point (ºC)Unavailable Boiling Point (ºC)Decomposes
Density (g/mL)1.02 Density (g/mL)Unavailable
Solubility in WaterInsoluble Solubility in WaterInsoluble
Other SolubilitiesInsoluble in ether; soluble in hot alchohol Other SolubilitiesUnavailable
Specific Gravity1.03 Vapor Pressure0 mm Hg (approx.)
OriginNatural OriginNatural
Method of IsolationMagnesium salt of stearic acid Method of IsolationAcid hydrolysis of fibrous cellulose
Intended FunctionLubricant that reduces wear and friction on equipment during the tablet process and aids in enhancing the flow properties of the powders during mixing. Intended FunctionIt serves multiple functions. Particularly, it is an excellent binder and disentegrant.
Pregelatanized Starch
Hypromellose
Other NamesAmglogen Other NamesHydroxy propyl methyl cellulose; 2-hydroxy propyl methyl ether cellulose
Molecular Formula(C6H10O5)n Molecular FormulaC56H108O30
CAS #9005-25-8 CAS #9004-65-3
Molecular Weight (g)Varies due to molecular weight Molecular Weight (g)1261.4512
Physical State & AppearanceFine, white solid Physical State & AppearanceWhite to off white powder
Melting Point (ºC)Decomposes Melting Point (ºC)Decomposes at 220
Boiling Point (ºC)Decomposes Boiling Point (ºC)n/a
Density (g/mL)1.5 Viscosity50-50,000 cps (2% sol.)
Solubility in WaterInsoluble Solubility in WaterSwells to form viscosity colloidal solution.
Other SolubilitiesUnavailable Other SolubilitiesSoluble in most organic solvents; insoluble in hot water and alcohol
OriginNatural OriginNatural
Method of IsolationDerived from corn Method of Isolation Derived from cellulose
Intended FunctionIt is primarily a binding agent used to improve tablet durability and integrity but is also used as a disentigrant. After ingestion, starch granules swell in the fluid environment of the stomach and force the tablet to break apart. Intended FunctionIt helps protect the tablet's integrity and aids in the ease of swallowing the tablets. It is also a constituent of the film-coating agent used on tablets.
Iron Oxide Blends
Polyethylene Glycol


Other NamesBecause Iron (iii) oxide is the primary component in these blends, all data provided is for this compound. Other NamesPEG; Macrogol; Polyoxyethylene; Aquaffin
Molecular FormulaFe2O3 Molecular FormulaH(OCH2)nOH
CAS #1332-37-2 CAS #25322-68-3
Molecular Weight (g)159.6882 Molecular Weight (g)Varies
Physical State & AppearanceReddish brown powder Physical State & AppearanceClear to white semi-solid
Melting Point (ºC)1538-1565 Melting Point (ºC)65
Boiling Point (ºC)Unavailable Boiling Point (ºC)Unavailable
Density (g/mL)5.24-5.25 Density (g/mL)1.101
Solubility in WaterInsoluble Solubility in WaterSoluble
Other SolubilitiesUnavailable Other SolubilitiesInsoluble in DMSO and ethanol
OriginIron oxide is natural; blend is sythetic. OriginSynthetic
Method of IsolationUnavailable Method of IsolationEsterfication of ethylene glycol
Intended FunctionIt is used as a coloring agent. Intended FunctionIt is an anti-redeposition agent, an emulsifying agent, and a water-soluble lubricant.
Povidone
Silicone Dioxide

Other Names1-ethenyl-2-pyrrolidinone; Polyvinylpyrrolidone K-30 Other NamesFree crystalline silica; Sand; Fumed silica
Molecular Formula(C6H9NO)n Molecular FormulaO2Si
CAS #9003-39-8 CAS #14808-60-7
Molecular Weight (g)10,000 avg. Molecular Weight (g)60.0848
Physical State & AppearanceWhite or creamy white powder Physical State & AppearanceColorless solid
Melting Point (ºC)225 (Varies with molecular weight) Melting Point (ºC)1710
Boiling Point (ºC)Depends on molecular weight (may decompose upon heating). Boiling Point (ºC)2230
Density (g/mL)Unavailable Density (g/mL)2.2-2.6
Solubility in WaterSoluble Solubility in WaterInsoluble
Other SolubilitiesSoluble in organic solvents Other SolubilitiesUnavailable
Specific Gravity1.23-1.29 Specific Gravity2.66
OriginUnavailable OriginNatural
Method of IsolationUnavailable Method of IsolationHydrolysis of silicon tetrachloride with water and then heating the hydrated oxide that is formed.
Intended FunctionIt is a dispersing agent to provide colloid stability, a controlled release agent, a binder, a stabilizer, and a film former. Intended FunctionIt promotes the flow of tableting powders and prevents them from sticking to the tablet presses. It promotes tablet disintegration and prevents caking.
Titanium Dioxide
Information that is listed as
unavailable either does not
apply or could not be found.


Other NamesTitanium oxide; Tioxide; Atlas White Titanium Dioxide
Molecular FormulaO2Ti
CAS #13463-67-7
Molecular Weight (g)79.8658
Physical State & AppearanceWhite powder
Melting Point (ºC)1855-3000
Boiling Point (ºC)2500-3000
Density (g/mL)4.26
Solubility in WaterInsoluble
pH7.5
Specific Gravity3.9-4.2
OriginNatural
Method of IsolationDerived from ilmenite or leuxocene ores
Intended FunctionIt is a pigment used for providing whiteness and opacity.

Last modified May 29, 2003.
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Created by Rianna Myers as an Honors Project for Dr. Glaser's Winter '03 Chemistry 212 class at the University of Missouri-Columbia.