Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
SPRAY
**3\. HOW TO USE STREPSILS MAX PRO DIRECT SPRAY** **Adults aged 18 years and older:** Administer one dose of 3 sprays to the back of the throat every 3–6 hours as required, up to a maximum of 5 doses in a 24 hour period. Spray at the back of the throat only. Do not inhale whilst spraying. **Do not use more than 5 doses (15 sprays) in a 24 hours period.** **Do not give to adolescents and children under 18 years.** **Do not use for longer than 3 days** unless your doctor tells you to. If symptoms persist or the pain worsen, or if any new symptoms occur, consult your doctor or pharmacist. **If you use more Strepsils Max Pro Direct Spray than you should**, you may feel drowsy or nauseous. You should seek immediate medical advice in the event of an overdose, even if you feel well. **If you forget to use Strepsils Max Pro Direct Spray.** Do not ‘double dose’ to make up for a forgotten dose. Simply carry on with your next dose as required. **Priming the pump** When using the pump for the first time (or after storage for a long period of time) you must first prime the pump. Point the nozzle away from you and spray a minimum of four times until a fine, consistent mist is produced. The pump is then primed and ready to use. **Using the spray** Aim the nozzle towards the back of the throat.  Using a smooth rapid motion, depress the pump **three times**, taking care to fully depress the pump for each spray, whilst removing the finger from the top of the pump between each spray.  Do not inhale whilst spraying.
OROPHARYNGEAL
Medical Information
**1\. WHAT STREPSILS MAX PRO DIRECT SPRAY IS AND WHAT IT IS USED FOR** The active ingredient (which makes Strepsils Max Pro Direct Spray work) is Flurbiprofen. It belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs provide relief by changing the body’s response to pain, swelling, and high temperature. Strepsils Max Pro Direct Spray is used for the short-term symptomatic relief of sore throat such as throat soreness, pain, difficulty swallowing and swelling. This medicine is for adults of age 18 years and over.
**2\. BEFORE USING STREPSILS MAX PRO DIRECT SPRAY** **Do not use Strepsils Max Pro Direct Spray if you:** - are allergic to Flurbiprofen or any of the other ingredients (see section 6 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_) or to aspirin or other painkillers - have (or have had two or more episodes of) a stomach ulcer, perforation or bleeding - have had a worsening of asthma, skin rash, itchy runny nose or facial swelling when previously taking Flurbiprofen, aspirin or similar medicines - have had gastrointestinal bleeding or perforation when previously taking NSAIDs - are taking other NSAIDs painkillers or more than 75mg aspirin a day - have severe liver or kidney problems - have heart problems, high blood pressure or blood coagulation disorder - have breathing difficulties - are in the last 3 months of pregnancy - are under 18 years old.
R02AX01
flurbiprofen
Manufacturer Information
RECKITT BENCKISER (SINGAPORE) PTE LTD
Reckitt Benckiser Healthcare Manufacturing (Thailand) Ltd
Active Ingredients
Documents
Patient Information Leaflets
Strepsils MaxPro Direct Spray PIL.pdf
Approved: October 12, 2021