Paracetamolum, Guaifenesinum, Phenylephrini hydrochloridum

Medicinal product name Hotex 500 mg/200 mg/10 mg powder for oral solution
Pharmaceutical form Powder for oral solution
Strength 500 mg/200 mg/10 mg 
Information from the MAH on shortages Not notified
Legal status OTC OTC
Package leaflet MS Word document 14-12-2021
Summary of product characteristics MS Word document 14-06-2018
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.
Guaifenesinum No data on active substance.
Phenylephrini hydrochloridum No data on active substance.

Medicinal products (6)

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 N5
(1 UD)
Paper/LDPE/Al/ionomer sachet    18-0105-01 Labelling text Labelling text Jun 14, 2018
 Not available (according to the information provided by wholesalers) currently no information on availability from any wholesaler N6
(1 UD)
Paper/LDPE/Al/ionomer sachet    18-0105-02 Labelling text Labelling text Jun 14, 2018
 Not available (according to the information provided by wholesalers) currently no information on availability from any wholesaler N10
(1 UD)
Paper/LDPE/Al/ionomer sachet    18-0105-03 Labelling text Labelling text Jun 14, 2018
 Not available (according to the information provided by wholesalers) currently no information on availability from any wholesaler N14
(1 UD)
Paper/LDPE/Al/ionomer sachet    18-0105-04 Labelling text Labelling text Jun 14, 2018
 Not available (according to the information provided by wholesalers) currently no information on availability from any wholesaler N15
(1 UD)
Paper/LDPE/Al/ionomer sachet    18-0105-05 Labelling text Labelling text Jun 14, 2018
 Not available (according to the information provided by wholesalers) currently no information on availability from any wholesaler N20
(1 UD)
Paper/LDPE/Al/ionomer sachet    18-0105-06 Labelling text Labelling text Jun 14, 2018

Registration information

Marketing authorisation No. 18-0105
Date of authorisation Jun 18, 2018
MA valid until Jun 17, 2023
Marketing authorisation holder, country Richard Bittner AG, Austria