Paracetamolum, Phenylephrini hydrochloridum, Guaifenesinum

Medicinal product name Theraflu 1000 mg/12.2 mg/200 mg powder for oral solution
Pharmaceutical form Powder for oral solution
Strength 1000 mg/12.2 mg/200 mg 
Information from the MAH on shortages Not available
predicted availability date: Sep 1, 2022
Legal status OTC OTC
Package leaflet MS Word document 11-05-2021
Summary of product characteristics MS Word document 21-01-2021
ATC code N02BE51 Analgesics

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.
Phenylephrini hydrochloridum No data on active substance.
Guaifenesinum No data on active substance.

Medicinal products (1)

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)
predicted availability date: Sep 1, 2022
currently no information on availability from any wholesaler N10
(1 UD)
Paper/LDPE/Al/ionomer sachet 8.71  16-0072-01 Labelling text Labelling text Jan 21, 2021

Registration information

Marketing authorisation No. 16-0072
Date of authorisation Apr 5, 2016
MA valid until For unlimited time
Marketing authorisation holder, country GlaxoSmithKline Dungarvan Ltd., Ireland