Phase
Condition
Common Cold
Acute Rhinitis
Treatment
Robitussin Maximum Strength Cough and Chest Congestion DM
Robitussin Maximum Strength Nighttime Cough DM
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant provides a signed and dated electronic informed consent documentindicating that the participant has been informed of and consents to all pertinentaspects of the study, before any assessment is performed and participant hasreviewed and is willing to follow the product label.
Participant aged 18 years or older at the time of electronic consent, inclusive ofall ethnicities, races and gender identities.
Participant reporting initiation of cough symptoms within 48 hours prior toinitiation of the virtual visit.
Participant reporting a minimum score of 5 (moderate) for cough associated withcommon cold symptoms and at least one other symptom of common cold (at least mildscore of 3) as per the WURSS-21 symptom domains.
Participant reporting at least one night's sleep has been disrupted in the previous 2 nights due to the symptoms of common cold.
Participant who is willing to self-treat their cough using the study treatment.
Participant who is in good general and mental health.
Participant who resides in the United States (except for Hawaii and Alaska).
Participant who owns a mobile device with access to stable internet connection andis willing to use their device to complete study surveys and assessments per theschedule of events.
Participant who has not taken any cough products containing dextromethorphan,guaifenesin, or doxylamine (example, Robitussin, Delsym, Vicks, Mucinex), or coughdrops/lozenges containing benzocaine or menthol (example, Cepacol, Halls, Ricola) orany natural cough products during the study.
Exclusion
Exclusion Criteria:
- Have a history of allergies (example, rash, hives, difficulty breathing, swelling offace, lips, tongue, or throat) to any medication or any kind or sensitivity toingredients in pain, cough, cold, and flu products; including the following activeingredients found in the Research products:
Active Ingredients - dextromethorphan, guaifenesin, doxylamine.
Inactive Ingredients - anhydrous citric acid, carboxymethylcellulose sodium,FD&C blue no. 1, FD&C red no. 40, glycerin, liquid glucose, menthol, naturaland artificial flavors, polyethylene glycol, propylene glycol, purified water,sodium benzoate, sodium citrate, sucralose, triacetin, xanthan gum.
Participant who is currently taking medications that may interact with the studyproducts.
Participant who is pregnant, lactating, or plans to be pregnant or lactating duringthe course of the study (self-report).
Participant who has taken any cough products containing dextromethorphan,guaifenesin, or doxylamine (example, Robitussin, Delsym, Vicks, Mucinex), or coughdrops/lozenges containing benzocaine or menthol (example, Cepacol, Halls, Ricola) orany natural cough products within 7 days prior to the virtual visit.
Have previously been diagnosed with:
prostate gland enlargement or difficulty urinating.
glaucoma (excessive pressure inside your eyes).
asthma, chronic bronchitis, chronic cough or chronic lung disease (difficultyin breathing and cough that won't go away).
Pneumonia (within the last 6 months).
Coronavirus disease (COVID-19) (within the last month).
- Are taking medication(s) to treat - psychiatric / mental health conditions (example,anxiety, depression) or Parkinson's disease. Medications such as:
- Monoamine oxidase inhibitor (MAOI) [example, Azilect, Emsam, Marplan, Nardil]or have stopped them within the last 2 weeks per their doctor's advice.
Are currently taking sedatives or tranquilizers (example, Ambien, Xanax, Klonopin).
Are taking drugs for heart problems such as quinidine, amiodarone or metoprolol,antidepressants such as fluoxetine and paroxetine, or antipsychotics such ashaloperidol and thioridazine.
Participant who is currently experiencing:
cough accompanied by fever, rash, or persistent headache OR
cough with too much phlegm.
Participant who is an employee of Lindus Health, either directly involved in theconduct of the study or a member of their immediate family; or a Haleon employeedirectly involved in the conduct of the study or a member of their immediate family.
Participant who has participated in other studies (including non-medicinal studies)involving investigational product(s) within 30 days prior to study entry.
Participant who has previously been enrolled in this study.
Participant sharing the same address as another participant who has been enrolled inthis study.
Participant who, in the opinion of the investigator or delegate, should notparticipate in the study, including a participant who meets any of the "stop use"criteria recommended by the label.
Study Design
Study Description
Connect with a study center
Lindus Health Limited
London, England SE1 0NW
United KingdomSite Not Available
Lindus Health Limited
New York, New York 10017
United StatesSite Not Available
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