Paracetamolum, Guaifenesinum, Phenylephrini hydrochloridum

Medicinal product name Colcaps 500 mg/100 mg/6.1 mg hard capsules
Pharmaceutical form Capsule, hard
Strength 500 mg/100 mg/6.1 mg 
Information from the MAH on shortages Not notified
Legal status OTC OTC
Package leaflet MS Word document 29-07-2021
Summary of product characteristics MS Word document 29-07-2021
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.
Guaifenesinum No data on active substance.
Phenylephrini hydrochloridum No data on active substance.

Medicinal products (4)

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 N8
(1 UD)
PVC/Al/paper blister    21-0123-01 Labelling text Labelling text Jul 29, 2021
 Not available (according to the information provided by wholesalers) currently no information on availability from any wholesaler N16
(1 UD)
PVC/Al/paper blister    21-0123-02 Labelling text Labelling text Jul 29, 2021
 Not available (according to the information provided by wholesalers) currently no information on availability from any wholesaler N24
(1 UD)
PVC/Al/paper blister    21-0123-03 Labelling text Labelling text Jul 29, 2021
 Not available (according to the information provided by wholesalers) currently no information on availability from any wholesaler N32
(1 UD)
PVC/Al/paper blister    21-0123-04 Labelling text Labelling text Jul 29, 2021

Registration information

Marketing authorisation No. 21-0123
Date of authorisation Jul 30, 2021
MA valid until Jul 29, 2026
Marketing authorisation holder, country Richard Bittner AG, Austria