Pharmacy Label Requirements for Respiratory Medications
Pharmacy labels for Ventolin inhaler, Breo Ellipta, mometasone nasal spray, and azithromycin should include complete medication information, dosage instructions, patient identifiers, and appropriate warnings to ensure safe and effective use.
General Label Requirements for All Medications
- All pharmacy labels must include patient name, date of dispensing, prescription number, prescriber name, and pharmacy contact information 1
- Include clear directions for use with specific frequency (e.g., "Use 1-2 puffs every 4-6 hours as needed for shortness of breath") 1
- Include the total quantity dispensed and number of refills remaining 1
- Include the medication's expiration date 1
- Include appropriate storage instructions (e.g., "Store at room temperature away from moisture") 1
Ventolin (Albuterol) Inhaler Label Requirements
- Include specific instructions: "Inhale 1-2 puffs by mouth every 4-6 hours as needed for shortness of breath or wheezing" 1
- Include the statement: "Shake well before each use" 1
- Include warning: "If using more than twice per week, contact your healthcare provider as your asthma may be worsening" 1
- Include instruction: "Rinse mouth after use to prevent throat irritation" 2
- Include the number of actuations/doses contained in the inhaler (typically 200 doses) 3
Breo Ellipta (Fluticasone Furoate/Vilanterol) Label Requirements
- Include specific instructions: "Inhale contents of one blister once daily at the same time each day" 4, 5
- Include warning: "Do not use to relieve sudden breathing problems" 5
- Include instruction: "Rinse mouth with water after use without swallowing to help reduce the risk of thrush" 6
- Include storage information: "Store at room temperature. Keep in a dry place. Discard 6 weeks after opening the foil tray or when the dose counter reads '0', whichever comes first" 4, 5
- Include warning: "Increased risk of pneumonia in patients with COPD" 7, 5
Mometasone Nasal Spray Label Requirements
- Include specific instructions: "Spray (specific number) spray(s) in each nostril once daily" 2
- Include the statement: "Shake well before each use" 2
- Include instruction: "Prime pump before first use by spraying 10 times or until fine mist appears" 2
- Include warning: "May cause nasal irritation or nosebleeds" 2
- Include storage information: "Store at room temperature. Discard after (specific number) of sprays or after (specific date)" 2
Azithromycin Label Requirements
- Include specific instructions with exact dosing schedule: "Take (specific number) tablet(s) by mouth on day 1, then (specific number) tablet(s) once daily for (specific number) days" 1
- Include instruction: "Take with or without food" 1
- Include warning: "Complete the full course of treatment even if feeling better" 1
- Include warning: "May cause diarrhea, nausea, or abdominal pain" 1
- Include warning: "May cause QT prolongation in patients with certain heart conditions" 1
Common Pitfalls and Special Considerations
- Avoid using medical abbreviations that could be misinterpreted (e.g., use "twice daily" instead of "BID") 1
- For pediatric patients, include both the dose in mg and the volume if liquid medication 1
- For Ventolin inhalers, note that different brands (Ventolin HFA, Proventil HFA, and ProAir HFA) deliver different fine particle doses despite containing the same total dose of albuterol sulfate 3
- For Breo Ellipta, emphasize that it is a maintenance medication and not for rescue use during acute symptoms 4, 5
- For medications with specific administration techniques (like inhalers and nasal sprays), consider including brief instructions or referring to patient information leaflets 2, 6