Paracetamolum, Phenylephrini hydrochloridum, Guaifenesinum

Medicinal product name Theraflu 500 mg/6.1 mg/100 mg capsules, hard
Pharmaceutical form Capsule, hard
Strength 500 mg/6.1 mg/100 mg 
Information from the MAH on shortages No information on expected shortages
Availability of medicinal product
Product No.Package sizeWholesalers' stock state
16-0073-02N16 Is available
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 (2)

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    16-0073-01 Labelling text Labelling text Dec 20, 2018
 Is available (according to the information provided by wholesalers)
(1211 containers)
Baltfarm "Vita-Farm", Euroaptieka, Oribalt Rīga, Recipe Plus, Magnum Medical N16
(1 UD)
PVC/Al/paper blister 6.93  16-0073-02 Labelling text Labelling text Dec 20, 2018

Registration information

Marketing authorisation No. 16-0073
Date of authorisation Apr 5, 2016
MA valid until For unlimited time
Marketing authorisation holder, country GlaxoSmithKline Dungarvan Ltd., Ireland