IP Library › Granted Patent US 12,403,103
Granted Patent B2
US 12,403,103 · App. 17/391,642 · Granted Sep 2, 2025

Compositions and methods useful for treatment of respiratory illness

Inventors: Kelly Lee Schmeichel (Cincinnati, OH); Jayant Eknath Khanolkar (Singapore, SG); Douglas William Gledhill (St. Peters, MO); Susan Elaine Criss (Maineville, OH); Niranjan Ramji (Mason, OH); Elaine Rose Costeines (Maineville, OH)
Assignee: The Procter & Gamble Company
A61K31/137A61K31/473A61K31/485A61K31/495A61K31/519A61K31/522A61K31/55A61K31/616A61K45/06
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Quick Facts
Patent No.
US 12,403,103
App. No.
17/391,642
Granted
Sep 2, 2025
Kind
B2
Abstract

Disclosed are compositions including phenylephrine, its free and addition salt forms, and mixtures thereof, alone, or in combination with other pharmaceutical actives. The compositions have a pH of about 2 to about 5 and are substantially free of aldehydes. Also disclosed are methods of treating respiratory illness through administration of a composition comprising phenylephrine, its free and addition salt forms, and mixtures thereof alone, or in combination with other pharmaceutical actives.

Claims (85)

1. A liquid composition comprising:

(a) phenylephrine hydrochloride;

(b) one or more additional actives selected from the group consisting of dextromethorphan hydrobromide, acetaminophen, guaifenesin, or combinations thereof;

(c) a flavorant;

(d) one or more sugar alcohols selected from the group consisting of glycerin and sorbitol or combinations thereof;

(e) one or more artificial sweeteners selected from the group consisting of sucralose, monoammonium glycyrrhizinate, or combinations thereof;

(f) one or more solvents selected from the group consisting of water and propylene glycol or combinations thereof;

(g) citric acid;

(h) sodium benzoate; and

(i) disodium ethylene diamine tetraacetic acid;

wherein the liquid composition has a pH of from about 2 to about 5;

wherein the liquid composition is a solution;

wherein the liquid composition comprises less than about 0.1%, by weight of the liquid composition, of aldehydes; and

wherein the liquid composition comprises a weight ratio of propylene glycol to glycerin of 1:1 to 4:1.

2. The liquid composition of claim 1 , wherein the liquid composition comprises from about 0.01 mg to about 15 mg of phenylephrine hydrochloride, per dose of the liquid composition.

3. The liquid composition of claim 1 , wherein the liquid composition comprises from about 0.001% to about 0.5%, by weight of the liquid composition, of phenylephrine hydrochloride.

4. The liquid composition of claim 1 , wherein the liquid composition comprises less than about 0.05%, by weight of the liquid composition, of total aldehydes.

5. The liquid composition of claim 1 , wherein the liquid composition comprises less than about 0.01%, by weight of the liquid composition, of total aldehydes.

6. The liquid composition of claim 1 , wherein the liquid composition comprises less than about 0.05%, by weight of the liquid composition of aldehydes, wherein the aldehydes are selected from the group consisting of benzaldehyde, p-tolyl aldehyde, or combinations thereof.

7. The liquid composition of claim 1 , wherein the liquid composition comprises less than about 0.01%, by weight of the liquid composition of aldehydes, wherein the aldehydes are selected from the group consisting of benzaldehyde, p-tolyl aldehyde, or combinations thereof.

8. The liquid composition of claim 1 , wherein the liquid composition comprises from about 0.0001% to about 10%, by weight of the liquid composition, of total additional active.

9. The liquid composition of claim 1 , wherein the one or more additional actives is acetaminophen.

10. The liquid composition of claim 1 , wherein the one or more additional actives is dextromethorphan hydrobromide.

11. The liquid composition of claim 1 , wherein the one or more additional actives is guaifenesin.

12. The liquid composition of claim 1 , wherein the one or more additional actives is acetaminophen, dextromethorphan hydrobromide, and guaifenesin.

13. The liquid composition of claim 1 , wherein the liquid composition comprises from about 40% to about 95%, by weight of the liquid composition, of total solvent.

14. The liquid composition of claim 1 , wherein the liquid composition comprises a ratio of propylene glycol to glycerin of 1:1 to 3:1.

15. A liquid composition comprising:

(a) phenylephrine hydrochloride;

(b) one or more additional actives selected from the group consisting of dextromethorphan, acetaminophen, doxylamine, guaifenesin, free or addition salt forms thereof, or combinations thereof;

(c) a flavorant;

(d) one or more sugar alcohols selected from the group consisting of glycerin, sorbitol, maltitol, mannitol, or combinations thereof;

(e) one or more artificial sweeteners selected from the group consisting of sodium saccharine, acesulfame potassium, sucralose, aspartame, monoammonium glycyrrhizinate, neohesperidin dihydrochalcone, thaumatin, neotame, cyclamates, or combinations thereof;

(f) one or more solvents selected from the group consisting of water, ethanol, propylene glycol, or combinations thereof;

(g) disodium ethylene diamine tetraacetic acid;

wherein the liquid composition has a pH of from about 2 to about 5;

wherein the liquid composition is a solution;

wherein the liquid composition comprises less than about 0.1%, by weight of the liquid composition, of benzaldehyde, p-tolyl aldehyde, or combinations thereof; and

wherein the liquid composition comprises a weight ratio of propylene glycol to glycerin of 1:1 to 4:1.

16. The liquid composition of claim 15 , wherein the liquid composition comprises from about 0.01 mg to about 15 mg of phenylephrine hydrochloride, per dose of the liquid composition.

17. The liquid composition of claim 15 , wherein the liquid composition comprises from about 0.001% to about 0.5%, by weight of the liquid composition, of phenylephrine hydrochloride.

18. The liquid composition of claim 15 , wherein the liquid composition comprises less than about 0.05%, by weight of the liquid composition, of benzaldehyde, p-tolyl aldehyde, or combinations thereof.

19. The liquid composition of claim 15 , wherein the liquid composition comprises less than about 0.01%, by weight of the liquid composition, of benzaldehyde, p-tolyl aldehyde, or combinations thereof.

20. The liquid composition of claim 15 , wherein the liquid composition comprises from about 0.0001% to about 10%, by weight of the liquid composition, of total additional active.

21. The liquid composition of claim 15 , wherein the one or more additional actives is acetaminophen.

22. The liquid composition of claim 15 , wherein the one or more additional actives is dextromethorphan hydrobromide.

23. The liquid composition of claim 15 , wherein the one or more additional actives is guaifenesin.

24. The liquid composition of claim 15 , wherein the one or more additional actives is acetaminophen, dextromethorphan hydrobromide, and guaifenesin.

25. The liquid composition of claim 15 , wherein the one or more sugar alcohols is glycerin and sorbitol.

26. The liquid composition of claim 15 , wherein the one or more artificial sweeteners is selected from the group consisting of sucralose, monoammonium glycyrrhizinate, or combinations thereof.

27. The liquid composition of claim 15 , wherein the liquid composition comprises from about 40% to about 95%, by weight of the liquid composition, of total solvent.

28. The liquid composition of claim 15 , wherein the one or more solvents is water and propylene glycol.

29. The liquid composition of claim 15 , wherein the liquid composition further comprises citric acid, sodium benzoate, or combinations thereof.

30. The liquid composition of claim 15 , wherein the liquid composition further comprises citric acid.

31. The liquid composition of claim 15 , wherein the liquid composition further comprises sodium benzoate.

32. The liquid composition of claim 15 , wherein the liquid composition comprises a ratio of propylene glycol to glycerin of 1:1 to 3:1.

33. A liquid composition comprising:

(a) phenylephrine hydrochloride;

(b) one or more additional actives selected from the group consisting of dextromethorphan, acetaminophen, doxylamine, guaifenesin, free or addition salt forms thereof, or combinations thereof;

(c) one or more flavorants selected from the group consisting of ethyl butyrate, benzyl acetate, benzyl butyrate, allyl isovalerate, allyl caproate, ethyl-2-methyl butyrate, ethyl methyl phenyl glycidate, oxanone (4-(p-hydroxyphenyl)-2-butanone, cis-3-hexenol, trans-2-hexenyl acetate, furaneol, maltol, or combinations thereof;

(d) one or more sugar alcohols selected from the group consisting of glycerin, sorbitol, maltitol, mannitol, or combinations thereof;

(e) one or more artificial sweeteners selected from the group consisting of sodium saccharine, acesulfame potassium, sucralose, aspartame, monoammonium glycyrrhizinate, neohesperidin dihydrochalcone, thaumatin, neotame, cyclamates, or combinations thereof;

(f) one or more solvents selected from the group consisting of water, ethanol, propylene glycol, or combinations thereof;

(g) disodium ethylene diamine tetraacetic acid;

wherein the liquid composition has a pH of from about 2 to about 5;

wherein the liquid composition is a solution; and

wherein the liquid composition comprises less than about 0.1%, by weight of the liquid composition, of aldehydes.

34. The liquid composition of claim 33 , wherein the liquid composition comprises from about 0.01 mg to about 15 mg of phenylephrine hydrochloride, per dose of the liquid composition.

35. The liquid composition of claim 33 , wherein the liquid composition comprises from about 0.001% to about 0.5%, by weight of the liquid composition, of phenylephrine hydrochloride.

36. The liquid composition of claim 33 , wherein the liquid composition comprises less than about 0.05%, by weight of the liquid composition, of total aldehydes.

37. The liquid composition of claim 33 , wherein the liquid composition comprises less than about 0.01%, by weight of the liquid composition, of total aldehydes.

38. The liquid composition of claim 33 , wherein the liquid composition comprises from about 0.0001% to about 10%, by weight of the liquid composition, of total additional active.

39. The liquid composition of claim 33 , wherein the one or more additional actives is acetaminophen.

40. The liquid composition of claim 33 , wherein the one or more additional actives is dextromethorphan hydrobromide.

41. The liquid composition of claim 33 , wherein the one or more additional actives is guaifenesin.

42. The liquid composition of claim 33 , wherein the one or more additional actives is acetaminophen, dextromethorphan hydrobromide, and guaifenesin.

43. The liquid composition of claim 33 , wherein the one or more sugar alcohols is glycerin and sorbitol.

44. The liquid composition of claim 33 , wherein the one or more artificial sweeteners is sucralose, monoammonium glycyrrhizinate, or combinations thereof.

45. The liquid composition of claim 33 , wherein the liquid composition comprises from about 40% to about 95%, by weight of the liquid composition, of total solvent.

46. The liquid composition of claim 33 , wherein the one or more solvents is water and propylene glycol.

47. The liquid composition of claim 33 , wherein the liquid composition further comprises citric acid, sodium benzoate, or combinations thereof.

48. The liquid composition of claim 33 , wherein the liquid composition further comprises citric acid.

49. The liquid composition of claim 33 , wherein the liquid composition further comprises sodium benzoate.

50. The liquid composition of claim 33 , wherein the liquid composition comprises a ratio of propylene glycol to glycerin of 1:1 to 4:1.

51. The liquid composition of claim 33 , wherein the liquid composition comprises a ratio of propylene glycol to glycerin of 1:1 to 3:1.

Continuity (4)
Continuation 16109835 · Aug 23, 2018
Continuation 16011700 · Jun 19, 2018
Continuation 11408299 · Apr 21, 2006
Related Publication 20210353562A1 · Nov 18, 2021
References Cited (160)
US 3169092A · Petraglia et al. · 1965 [cited by applicant]
US 3293045A · Griffin · 1966 [cited by applicant]
US 3480185A · Steinberg et al. · 1969 [cited by applicant]
US 3710795A · Higuchi et al. · 1973 [cited by applicant]
US 4049803A · Cotty et al. · 1977 [cited by applicant]
US 5196436A · Smith · 1993 [cited by applicant]
US 5296209A · Simone et al. · 1994 [cited by applicant]
US 5480674A · Peterson · 1996 [cited by applicant]
US 5660833A · Medenica · 1997 [cited by applicant]
US 5759579A · Singh et al. · 1998 [cited by applicant]
US 6028222A · Dietlin et al. · 2000 [cited by applicant]
US 6187340B1 · Fukuta et al. · 2001 [cited by applicant]
US 6218428B1 · Chynn · 2001 [cited by applicant]
US 6287597B1 · Gordziel · 2001 [cited by applicant]
US 6572849B2 · Shahinian, Jr. · 2003 [cited by applicant]
US 10022339B2 · Martin et al. · 2018 [cited by applicant]
US 10098873B2 · Martin · 2018 [cited by applicant]
US 10688089B2 · Schmeichel et al. · 2020 [cited by applicant]
US 10722848B2 · Hester et al. · 2020 [cited by applicant]
US 11491151B2 · Schmeichel et al. · 2022 [cited by applicant]
US 20020061340A1 · Shahinian, Jr. · 2002 [cited by applicant]
US 20020082307A1 · Dobrozsi et al. · 2002 [cited by applicant]
US 20030026826A1 · Cherukuri et al. · 2003 [cited by applicant]
US 20030083354A1 · Kiel et al. · 2003 [cited by applicant]
US 20030118654A1 · B. Santos et al. · 2003 [cited by applicant]
US 20040029864A1 · MacMillan · 2004 [cited by applicant]
US 20040054012A1 · Dietlin et al. · 2004 [cited by applicant]
US 20040162273A1 · Achong et al. · 2004 [cited by applicant]
US 20040259952A1 · Abbas et al. · 2004 [cited by applicant]
US 20040259955A1 · Umehara · 2004 [cited by applicant]
US 20050214349A1 · Nie et al. · 2005 [cited by applicant]
US 20050266031A1 · Dickerson et al. · 2005 [cited by applicant]
US 20050266032A1 · Srinivasan et al. · 2005 [cited by applicant]
US 20050267222A1 · Iwata et al. · 2005 [cited by applicant]
US 20060039973A1 · Aldritt et al. · 2006 [cited by applicant]
US 20060110476A1 · Haber et al. · 2006 [cited by applicant]
US 20060121066A1 · Jaeger et al. · 2006 [cited by applicant]
US 20060148837A1 · Giordano et al. · 2006 [cited by applicant]
US 20060188450A1 · Clarot · 2006 [cited by applicant]
US 20060216393A1 · Froseth et al. · 2006 [cited by applicant]
US 20070024972A1 · Kuerz · 2007 [cited by applicant]
US 20070098785A1 · Clarot et al. · 2007 [cited by applicant]
US 20070178123A1 · Levenson et al. · 2007 [cited by applicant]
US 20070179199A1 · Henning et al. · 2007 [cited by applicant]
US 20070197661A1 · Bubnis et al. · 2007 [cited by applicant]
US 20070249727A1 · Martin · 2007 [cited by applicant]
US 20070254027A1 · Martin et al. · 2007 [cited by applicant]
US 20080014274A1 · Bubnis et al. · 2008 [cited by applicant]
US 20080069874A1 · Hall et al. · 2008 [cited by applicant]
US 20100266699A1 · Buehler et al. · 2010 [cited by applicant]
US 20110136851A1 · Jaeger et al. · 2011 [cited by applicant]
US 20180338933A1 · Schmeichel · 2018 [cited by applicant]
US 20180360778A1 · Schmeichel · 2018 [cited by applicant]
US 20180360779A1 · Schmeichel · 2018 [cited by applicant]
US 20180360780A1 · Schmeichel · 2018 [cited by applicant]
US 20180360781A1 · Schmeichel · 2018 [cited by applicant]
US 20190008851A1 · Schmeichel · 2019 [cited by applicant]
US 20200268746A1 · Schmeichel · 2020 [cited by applicant]
EP 0306469 · 1989 [cited by applicant]
EP 0387933A1 · 1990 [cited by applicant]
EP 0473159A1 · 1992 [cited by applicant]
EP 1051155B1 · 2002 [cited by applicant]
EP 1559433A1 · 2005 [cited by applicant]
EP 1283043B1 · 2008 [cited by applicant]
GB 36747 · 1960 [cited by applicant]
GB 836747A · 1960 [cited by applicant]
GB 895495A · 1962 [cited by applicant]
GB 1121358A · 1968 [cited by applicant]
JP S6333327A · 1988 [cited by applicant]
JP H0780760A · 1995 [cited by applicant]
JP 1995080760B · 1995 [cited by applicant]
JP H09286723A · 1997 [cited by applicant]
JP H09286724A · 1997 [cited by applicant]
JP H09286726A · 1997 [cited by applicant]
JP H10167988A · 1998 [cited by applicant]
JP 2002212107A · 2002 [cited by applicant]
JP 2004217596 · 2004 [cited by applicant]
JP 2004300138A · 2004 [cited by applicant]
JP 2005060294A · 2005 [cited by applicant]
WO 9204559A1 · 1992 [cited by applicant]
WO 9408551 · 1994 [cited by applicant]
WO 9614828A1 · 1996 [cited by applicant]
WO 03011306A1 · 2003 [cited by applicant]
WO 2003047502A1 · 2003 [cited by applicant]
WO 2003059085A1 · 2003 [cited by applicant]
WO 2004066978A1 · 2004 [cited by applicant]
WO 2004084637A1 · 2004 [cited by applicant]
WO 2005023236 · 2005 [cited by applicant]
WO 2006022996A2 · 2006 [cited by applicant]
WO 2007098128A1 · 2007 [cited by applicant]
WO 2007101115 · 2007 [cited by applicant]
WO 2007122581A2 · 2007 [cited by applicant]
WO 2014120021A1 · 2014 [cited by applicant]
“A Bevy of Bottles”, PMPNews.com; Aug. 7, 1998—cited in EP opposition Oct. 28, 2014. [cited by applicant]
All Office Actions for U.S. Appl. No. 16/109,823, filed Aug. 23, 2018. [cited by applicant]
International Search Report and Written Opinion dated May 27, 2009. [cited by applicant]
All Office Actions for U.S. Appl. No. 11/413,766, filed Apr. 28, 2006. [cited by applicant]
All Office Actions for U.S. Appl. No. 11/408,299, filed Apr. 21, 2006. [cited by applicant]
All Office Actions for U.S. Appl. No. 11/657,860, filed Jan. 25, 2007. [cited by applicant]
All Office Actions for U.S. Appl. No. 15/384,369, filed Dec. 20, 2006. [cited by applicant]
All Office Actions for U.S. Appl. No. 16/011,700, filed Jun. 19, 2018. [cited by applicant]
All Office Actions for U.S. Appl. No. 16/109,827, filed Aug. 23, 2018. [cited by applicant]
All Office Actions for U.S. Appl. No. 16/109,830, filed Aug. 23, 2018. [cited by applicant]
All Office Actions for U.S. Appl. No. 16/109,835, filed Aug. 23, 2018. [cited by applicant]
All Office Actions, U.S. Appl. No. 15/930,540. [cited by applicant]
All Office Actions, U.S. Appl. No. 16/128,579. [cited by applicant]
Anonymous: “Alka Seltzer Plus Cold & Cough Liquid”, Internet, URL:HTTP://www.alkaseltzer.com/asp/products/colcough_liquid.html. [cited by applicant]
Anonymous: “New technologies unveiled by Magplastic at dring TEC-PET point 2005”, Magplastic, Blow-Moulding Technology, Sep. 12, 2005; http://www.magplastic.com/PressReviews/2005%20-%20New%technologies.pdf. [cited by applicant]
Bindra et. al., Pharmaceutical Research, vol. 11, Issue No. 7, 1994, pp. 1060-1064. [cited by applicant]
Chafetz, L. et al., “Phenolic Cyclization of Epinephrine, Metaproterenol, Metaraminol, Phenylephrine, and Terbutaline with Formaldehyde”, Pharmaceutical Research, 1987, Plenum Publishing, vol. 4, No. 2, pp. 158-161. [cited by applicant]
Chi, Susan, “Oxidative degradation of Monoetahnolamine”, Presentation at the First national Conference of Carbon Sequestration, Washington DC, May 14-14, 2001. [cited by applicant]
Covonia Cold & Flu Marketing Authorization dated Apr. 5, 2004—printed on Oct. 29, 2014. [cited by applicant]
Das Gupta et al., “Stability of Phenylephrine Hydrochloride nasal Drops”, American Journal of Hospital Pharmacy, vol. 29, pp. 870-873, (1972). [cited by applicant]
Drug Label for Tylenol Cold Multi-Symptom Daytime—downloaded from www.drugcite.com Oct. 29, 2014. [cited by applicant]
El-Shibini, H.A.M., et al., “The stability of Phenylephrine, Part 1: The Rate of Degradation of the Amino Group”. [cited by applicant]
Extract from Covonia website www.covonia.co.uk.com; printed Oct. 29, 2014. [cited by applicant]
Fenaroli's handbook of flavor ingredients, fifth ed. G. A. Burdock 2005, pp. 3-4, 221-222, 299-300, 671-672, 781-782, 1414-1415 and 1616-1617. [cited by applicant]
Fernandez, M.T. et al., “Iron and copper chelation by flavonoids: an electrospray mass spectrometry study”, Journal of Inorganic Biochemistry, vol. 92, pp. 105-111 (2002). [cited by applicant]
Gupta, et al., “Chemical Stabilities of Lignocaine Hydrochloride and Phenylephrine Hydrochloride in Aqueous Solution”, Journal of Clinical and Hospital Pharmacy, vol. 11, No. 6, pp. 449-452, (1986). [cited by applicant]
Li, Zhong et al., “Detection and quantification of low-molecular-weight aldehydes in pharmaceutical excipients by headspace gas chromatography”, Journal of Chromatography A, 1104 (2006) 1-10. [cited by applicant]
Luduena, F.P., et al., “Effect of Ultra-Violet Irradiation Of Phenylephrine Solutions,” J. Pharm. Pharmacol., vol. 15, pp. 538-543, 1963. [cited by applicant]
Marin, A., et al., “Major Degradation Product Identified in Several Pharmaceutical Formulations against the Common Cold”, Analytical Chemistry. vol. 77, No. 2, pp. 471-477, Jan. 15, 2005. [cited by applicant]
Metric conversion, Milliters to US Teaspoons, Jul. 22, 2018, acccessed https://metric-conversions.org/volume/milliliters-to-us-teaspoons.htm (Year: 2018). [cited by applicant]
Milliard, B.J., “The stability of aqueous solutions of phenylephrine at elevated temperatures: identification of the decomposition products”, Journal of Pharm. Pharmacol., vol. 25, pp. 24P-31P, (1973). [cited by applicant]
Pharmaceutical and Medical Packaging (PMP, Jul. 1998). [cited by applicant]
Popenoe, D.D., “P&G Poster: Global Collaboration to Overcome Phenylephrine Degradation in Latin America OTC Products”. [cited by applicant]
Public Assessment Report for PL 00240/0144; Published by Medicines and Healthcare Products Regulatory Agency, “Thornton and Ross Cold and Flu Formula Oral Solution”, printed Oct. 29, 2014. [cited by applicant]
Reckitt Benckiser Lemship Document 12: Lemon Flavour Description, issued on Jan. 13, 2000. [cited by applicant]
Reckitt Benckiser Lemsip Aldehyde Content Summary dated Oct. 27, 2014; printed Oct. 30, 2014. [cited by applicant]
Reckitt Benckiser Lemsip Assembly Method dated Oct. 24, 2014; printed Oct. 30, 2014. [cited by applicant]
Reckitt Benckiser Lemsip Document 13: Lemon flavor description, issued on Apr. 20, 2016. [cited by applicant]
Reckitt Benckiser Lemsip Document 14: Certificate of analysis for batch No. 320613, Jul. 25, 2013. [cited by applicant]
Reckitt Benckiser Lemsip Invoice dated Oct. 29, 2014; printed Oct. 30, 2014. [cited by applicant]
Reckitt Benckiser Lemsip Invoice to 3rd party, dated Apr. 6, 2004. [cited by applicant]
Reckitt Benckiser Lemsip Master Formulation Bill of Material dated Oct. 21, 2014; printed Oct. 30, 2014. [cited by applicant]
Reckitt Benckiser Lemsip Master Formulation Specification dated Oct. 21, 2014; printed Oct. 30, 2014. [cited by applicant]
Reckitt Benckiser Lemsip Packaging Pictures dated Oct. 29, 2014; printed Oct. 30, 2014. [cited by applicant]
Reckitt Benckiser Lemsip pH Summary dated Oct. 29, 2014; printed Oct. 30, 2014. [cited by applicant]
Reckitt Benckiser Lemsip Product Code dated Apr. 27, 2016. [cited by applicant]
Reckitt Benckiser Lemsip Sachets Packaging Record dated Mar. 24, 2004; printed Oct. 30, 2014. [cited by applicant]
Reckitt Benckiser Lemsip Total Aldehyde Content Summary—printed Oct. 30, 2014. [cited by applicant]
Reckitt Benckiser Lemsip Variation Application dated Oct. 1, 2001; printed Oct. 30, 2014. [cited by applicant]
Reckitt Benckiser Lemsip Variation Application Type II dated Oct. 4, 2001; printed Oct. 30, 2014. [cited by applicant]
Reckitt Benckiser Lemsip Variation Approval issued by the Medicines Control Agency dated Dec. 12, 2001; printed Oct. 30, 2014. [cited by applicant]
Remington (Science and Practice of Pharmacy), 19th ed., vol. 1, p. 806, 1995 p. 1-4. [cited by applicant]
Schou, S.A. et al., “Studies on the durability of Drugs—Manufacture and Stability of Metaoxedrine (Phenylephrine, Neo-Synephrine) Solution for Injection”, Farm., vol. 25, pp. 350-357, (1951). [cited by applicant]
Summary of Product Characteristics for Covonia Cold and Flu—printed on Oct. 29, 2014. [cited by applicant]
The United States Pharmacopeia, The National Formulary, USP 23, NF 18, Jan. 1, 1995, 8 Pages. [cited by applicant]
Third Party Opposition filed for European Patent Application Ser. No. 07735601.2, dated Nov. 7, 2014, 19 pages. [cited by applicant]
Troup, A.E., “Degradation of Phenylephrine Hydrochloride in Tablet Formulations Containing Aspirin”, Journal of Pharmaceutical Sciences, vol. 53, pp. 375-379, (1964). [cited by applicant]
United States Pharmacopeia 21st Review, National Formulary 16th Review, U.S. Pharmacopeial Convention, Rockville, MD, 1985, p. 828. [cited by applicant]
West, G.B., et al., “A note on the stability of solutions of Phenylephrine”, Journal of Pharm Pharmacol., vol. 12, pp. 113-115, (1960). [cited by applicant]
Whittet, T.D. et al., “Factors Affecting Drug Stability”, American Journal of Hospital Pharmacy, vol. 21, pp. 440-453, (1964). [cited by applicant]
All Office Actions; U.S. Appl. No. 17/498,152, filed Oct. 11, 2021. [cited by applicant]
U.S. Appl. No. 17/498,152, filed Oct. 11, 2021, to Kelly Lee Martin Schmeichel et. al. [cited by applicant]
PCT Search Report and Written Opinion for PCT/1B2007/051469 dated Jan. 27, 2009, 11 pages. [cited by applicant]
EP Search Report and Written Opinion for 13187884.5-1464 dated Mar. 27, 2014, 6 pages. [cited by applicant]
Database WPI Week 199539 1-13, Thomson Scientific, London, GB; AN1988-080731, XP002520889; 1-2 pages. [cited by applicant]
Third Party Opposition filed for European Patent Application Ser. No.07735602.0-1464, Dated Nov. 6, 2014; 14 pages. [cited by applicant]
All Office Actions; U.S. Appl. No. 17/590,796, filed on Feb. 1, 2022. [cited by applicant]