Patient description: A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.

Clinical trial eligibility criteria: eligible ages (years): 6.0-11.0,  Nasal Congestion Associated With the Common Cold Male or female subjects, ages 6 through 11 years, are experiencing the common cold, but are otherwise healthy. 2. Subjects have an onset of cold symptoms within the past 2.5 days before screening and are experiencing self-reported nasal congestion of at least stuffy severity (score = 3 or 4). 3. Subjects have at least two of the following additional symptoms due to common cold: runny nose, sneezing, sore throat, headache, body achiness, and cough, as deemed by the parent. 4. Subjects can swallow oral tablets without chewing them (based on a pretest of successfully swallowing a placebo tablet at screening) 5. Findings from the medical history review and vital signs are within the range of clinical acceptability, as determined by the investigator. 6. Subject and legally authorized representative are likely to be compliant and complete the study. 7. Subject's legally authorized representative has signed and dated the informed consent form. Subject has given verbal assent, and has signed and dated the informed assent form. 8. Female subjects who have reached menarche must have a negative urine pregnancy test at screening. These subjects must have practiced abstinence for at least three months prior to study entry and for the duration of the study. A second pregnancy test will be given when the subject returns to the clinic after the last dose. 9. Subject and legally authorized representative can read and understand English. 10. Subject's legally authorized representative who signs informed consent is available to administer all assessments and study medication on days 1 and 2  Have any of the following medical conditions: heart disease, high blood pressure, thyroid disease, diabetes, peripheral vascular disease, increased intraocular pressure, prostatic hypertrophy 2. Are under treatment for a hyperexcitability disorder with a medication regimen that has not been stable for at least 3 months 3. Are currently experiencing an asthmatic episode 4. Are experiencing symptoms of seasonal or perennial allergic rhinitis 5. Are currently or within the last 24 hours having symptoms of vomiting or diarrhea 6. Have been exposed to immediate family members with the flu within the past week 7. Are exhibiting signs or symptoms of, or diagnosed with sinusitis, pneumonia, strep throat, acute otitis media, or influenza 8. Are experiencing a fever 103˚F or higher at screening 9. Are from homes where there is smoking in the home around the child. 10. Are currently taking a monoamine oxidase inhibitor (MAOI), or have taken a MAOI within two weeks of screening (e.g., isocarboxazid Marplan, phenelzine Nardil, selegiline Eldepryl, Emsam, Zelapar, and tranylcypromine Parnate). Note: subjects may not discontinue taking a MAOI solely of the purposes of qualifying for the study. 11. Have a known sensitivity or allergy to pseudoephedrine, phenylephrine, or acetaminophen or any of the excipients of the drug product 12. Have taken any oral cold or allergy medicine within 12 hours of enrollment, or intranasal decongestants within 24 hours of enrollment except for single-ingredient OTC analgesics 13. Have the need to take additional medications, including cough and cold (i.e., oral or intranasal antihistamines, intranasal steroids, intranasal decongestants), or herbal/dietary supplements during the study, with the exception of acetaminophen, a medication regimen for a hyperexcitability disorder that has been stable for at least three months or a daily vitamin or multivitamin/multimineral supplement 14. Have participated in another clinical study within 30 days before entry 15. Have another child from the household currently participating in this study 16. Have a history of drug, alcohol, or tobacco use (older children) 17. Are involved directly or indirectly with the conduct and administration of this study (i.e., children of principal investigator, subinvestigator, study coordinators, other study personnel, employees of Perrigo, and the families of each)