Paracetamolum, Pseudoephedrini hydrochloridum

Medicinal product name Theraflu SN 500 mg/30 mg powder for oral solution
Pharmaceutical form Powder for oral solution
Strength 500 mg/30 mg 
Information from the MAH on shortages No information on expected shortages
Legal status OTC OTC
Package leafletMS Word document 05-11-2020
Summary of product characteristicsMS Word document 20-08-2020
ATC code N02BE51 Analgesics
R05X Cough and cold preparations

Important notice

Additional information regarding the use for persons aged 75+

If used as "ANALGESICS"
SubstanceClassComment
ParacetamolumASuitable for older persons. Maximum dose in regular use 2-3 g/day. Note paracetamol in OTC drugs and combination products. Overdose is hepatotoxic. Concurrent use with warfarin is possible if INR values are monitored.
Pseudoephedrini hydrochloridum No data on active substance.
If used as "COUGH AND COLD PREPARATIONS"
SubstanceClassComment
Paracetamolum No data on active substance.
Pseudoephedrini hydrochloridum No data on active substance.

Medicinal products (5)

Availability of medicinal product Wholesalers Package size, content Primary packaging Maximum admissible pharmacy price (€ incl. VAT) Product No. Labelling
 Not available (according to the information provided by wholesalers) currently no information on availability from any wholesaler N6
(500 mg/30 mg)
PE terephthalate/ LDPE/Al/LDPE sachet    14-0136-01 Labelling text Labelling text Jan 24, 2019
 Not available (according to the information provided by wholesalers) currently no information on availability from any wholesaler N8
(500 mg/30 mg)
PE terephthalate/ LDPE/Al/LDPE sachet    14-0136-02 Labelling text Labelling text Jan 24, 2019
 Not available (according to the information provided by wholesalers) currently no information on availability from any wholesaler N10
(500 mg/30 mg)
PE terephthalate/ LDPE/Al/LDPE sachet 8.48  14-0136-03 Labelling text Labelling text Jan 24, 2019
 Not available (according to the information provided by wholesalers) currently no information on availability from any wholesaler N12
(500 mg/30 mg)
PE terephthalate/ LDPE/Al/LDPE sachet    14-0136-04 Labelling text Labelling text Jan 24, 2019
 Not available (according to the information provided by wholesalers) currently no information on availability from any wholesaler N14
(500 mg/30 mg)
PE terephthalate/ LDPE/Al/LDPE sachet    14-0136-05 Labelling text Labelling text Jan 24, 2019

Registration information

Marketing authorisation No. 14-0136
Date of authorisation Jun 20, 2014
MA valid until For unlimited time
Marketing authorisation holder, country GlaxoSmithKline Dungarvan Ltd., Ireland