TEVA COLD RELIEF 200/30 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

IBUPROFEN PSEUDOEPHEDRINE HYDROCHLORIDE

Available from:

Procter & Gamble (Health & Beauty Care) Limited

INN (International Name):

IBUPROFEN PSEUDOEPHEDRINE HYDROCHLORIDE

Dosage:

200/30 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product not subject to medical prescription

Authorization status:

Authorised

Authorization date:

0000-00-00

Patient Information leaflet

2 

PACKAGE LEAFLET: INFORMATION FOR THE USER 

TEVA COLD RELIEF 200 MG/30 MG FILM-COATED TABLETS

Ibuprofen and Pseudoephedrine hydrochloride 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING
THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT 
INFORMATION FOR YOU. 
This medicine is available without prescription. Always take this
medicine exactly as described in this 
leaflet or as your doctor or pharmacist have told you. 
- 
KEEP THIS LEAFLET. You may need to read it again. 
- 
Ask your pharmacist if you need more information or advice. 
- 
If you get any side effects, talk to
your doctor or pharmacist. This includes any possible side
effects 
not listed in this leaflet. See section 4. 
- 
You must talk to a doctor if you do not feel better or if you
feel worse after 5 days. 

WHAT IS IN THIS LEAFLET 
1. 
What Teva Cold Relief 200 mg/30 mg Film-coated Tablets is and
what it is used for 
2. 
What you need to know before you take Teva Cold Relief 200 mg/30
mg Film-coated Tablets 
3. 
How to take Teva Cold Relief 200 mg/30 mg Film-coated Tablets 
4. 
Possible side effects 
5. 
How to store Teva Cold Relief 200 mg/30 mg Film-coated Tablets 
6. 
Contents of the pack and other information 

This medicine is called Teva Cold Relief 200 mg/30 mg Film-coated
Tablets but will be referred to as Teva 
Cold Relief 200 mg/30 mg throughout this leaflet. 

1. 
WHAT TEVA COLD RELIEF 200 MG/30 MG IS AND WHAT IT IS USED FOR 

Teva Cold Relief 200 mg/30 mg contains the active
substances ibuprofen, a non-steroidal anti-inflammatory 
drug (NSAID), and pseudoephedrine, which is
a nasal decongestant.  

  Ibuprofen reduces pain, swelling and high temperature.  

  Pseudoephedrine acts on the blood vessels in the nose to relieve
nasal congestion. 

Teva Cold Relief 200 mg/30
mg is indicated for the symptomatic relief of nasal congestion
wi

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Teva Cold Relief 200 mg/30 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 200 mg ibuprofen and 30 mg pseudoephedrine hydrochloride equivalent to 24.6 mg
pseudoephedrine
Excipients with known effect:
Colouring agent’s tartrazine (E102, 0.47 mg/film-coated tablet) and sunset yellow FCF (E110, 0.07 mg/film-coated
tablet). Soya lecithin (E322, 0.37 mg/film-coated tablet).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets
Yellow coloured, oval shaped, biconvex film-coated tablet (dimension: approx. 15.6 mm x 7.7 mm).
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Symptomatic relief of nasal/sinus congestion with headache, fever and pain associated with the common cold and
influenza.
Teva Cold Relief 200 mg/30 mg Film-coated Tablets are indicated in adults and adolescents aged 15 and over.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults and adolescents aged 15 and over:
1 tablet (equivalent to 200 mg ibuprofen and 30 mg pseudoephedrine hydrochloride) every 4-6 hours if necessary.
For more severe symptoms, 2 tablets (equivalent to 400 mg ibuprofen and 60 mg pseudoephedrine hydrochloride)
every 6-8 hours if necessary, to a maximum total daily dose.
The maximum total daily dose of 6 tablets (equivalent to 1200 mg ibuprofen and 180 mg pseudoephedrine
hydrochloride) must not be exceeded.
Treatment should not be continued for more than 5 days.
This combination product should be used where both, the decongestant action of Pseudoephedrine hydrochloride and
the analgesic and/or anti-inflammatory action of Ibuprofen, are required. If one symptom (_either _nasal congestion _or_
headache and/or fever) predominates, single-agent therapy is prefe