Claim Verification Information for Day and Night Nurse Range

The UK Codes of Non-broadcast and Broadcast Advertising (the CAP and BCAP Codes) require that advertisers provide sufficient information, about comparisons with identifiable competitor products, to enable consumers to check the comparison for themselves.

GSK are currently using the claims ‘Nothing Stronger for Cold and Flu Relief’, ‘Unbeatable Strength for Cold and Flu Relief’ and ‘Nothing is stronger to knock out Cold and Flu’ on various Day Nurse and Night Nurse promotional materials.

The claims are supported by the information set out below.

Introduction

The Day and Night Nurse products are available as a range of medicines, each with more than one active ingredient, intended to treat the various symptoms of colds, chills and influenza (flu). The Day and Night Nurse range is sold over the counter from pharmacies. The products in the range, their active ingredients and the symptoms treated are shown in the table below.

Table 1

Product Active Ingredient How they work
Day Nurse Paracetamol 1000 mg/30 ml Pain relief and fever reduction
Pseudoephedrine hydrochloride 60 mg/30 ml Decongestant
Pholcodine 10 mg/30 ml Cough suppressant
Night Nurse Paracetamol 1000 mg/20 ml Pain relief and fever reduction
Promethazine hydrochloride 20 mg/20 ml Antihistamine
Dextromethorphan hydrobromide 15 mg/20 ml Cough suppressant
Day Nurse Capsules Paracetamol 500 mg/cap Pain relief and fever reduction
Pseudoephedrine hydrochloride 30 mg/cap Decongestant
Pholcodine 5 mg/cap Cough suppressant
Night Nurse Capsules Paracetamol 500 mg/cap Pain killer
Promethazine hydrochloride 10 mg/cap Antihistamine
Dextromethorphan hydrobromide 7.5 mg/cap Cough suppressant
Day & Night Nurse Capsules
Day Time Capsules
Paracetamol 500 mg/cap Pain killer and fever reduction
Pseudoephedrine hydrochloride 30 mg/cap Decongestant
Pholcodine 5 mg/cap Cough suppressant
Day & Night Nurse Capsules
Night Time Capsules
Paracetamol 500 mg/cap Pain relief and fever reduction
Promethazine hydrochloride 10 mg/cap Antihistamine
Dextromethorphan hydrobromide 7.5 mg/cap Cough suppressant

The claims are based on a comparative review of all medicines with: more than one active ingredient (multi-active), relieving more than one symptom (multi-symptom), that are recommended for cold and flu, and are available without a prescription.

Medicines containing only one ingredient are not included in the comparison as they are not comparable to medicines in the Day and Night Nurse range i.e. those with more than one active, that provide multi-symptom relief.

Maximum UK permitted doses for active ingredients used in cold and flu treatments

Maximum doses for the active ingredients in medicines detailed in Table 2 below, were taken from the MHRA lists of maximum allowable strengths for Over The Counter (OTC) medicines and from the British National Formulary.* The above searches confirmed that all Day Nurse and Night Nurse products contain the maximum dose of each of the active ingredients.

Active ingredients in cold and flu products along with the maximum dose in Pharmacy-only products

Active Ingredient Maximum Dose
Pseudoephedrine Hydrochloride 60 mg1
Paracetamol 1000 mg – (500 mg max strength tablet)1
Pholcodine 10 mg2
Promethazine Hydrochloride 20 mg2
Dextromethorphan Hydrobromide 15 mg1
Guaifenesin 200 mg1
Phenylephrine hydrochloride 10 mg (12.2mg with salt)1
Caffeine 60 mg3
Diphenhydramine hydrochloride 50 mg3
Cetylpyridinium chloride 3 mg tablet/5 mg liquid1
Ibuprofen 400 mg1
Doxylamine succinate 10 mg3
Codeine phosphate 30 mg2
Aspirin 500 mg - max strength; 32 tabs or caps3

1 Maximum dose taken from List A, B or C on the MHRA website.

2 Maximum dose extrapolated from the BNF, as a guide, since the active ingredient is not detailed in List A, B or C.

3 Maximum dose included as a guide based on this being the maximum dose for the active ingredient that has been observed through the search of medical literature conducted; where Lists A, B and C and the BNF do not refer to these active ingredients.

Multi-active and multi-symptom products for cold and flu

Multi-active and multi-symptom medicines were identified using an active specific search on the MHRA website, based on a preliminary search of the medicines listed in the PAGB OTC Directory. Additionally,

*BNF is a publication written by the British Medical Association and the Royal Pharmaceutical Society and can be used as a reference guide for prescribing and dispensing

**RAMA is an MHRA (Medicines and Healthcare Regulatory Agency) maintained database that documents all current granted licence details for medicinal products in the United Kingdom.

the Electronic Medicines Compendium website (medicines.org.uk) was utilised along with conducting two RAMA** searches for the indications of ‘COLD’ and ‘FLU’ with all products checked and included/excluded based on the criteria below.

Search Criteria
The search was based on the following criteria:

Search Inclusions:

  • All medicines licensed for purchase without a prescription
  • All medicines containing 2 or more active ingredients, indicated for cold and flu

Search Exclusions:

  • Medicines indicated for cold and flu only containing 1 active ingredient
  • Medicines which are only available on prescription
  • Medicines which only treat one symptom (e.g. headache)
  • Traditional Herbal Registration (THR) Licensed Products
  • Products not currently marketed

The results of the search can be found in Appendix 1 which is a tabulated list of multi-active medicines, which meet the criteria described above.

Conclusion

The information presented above and in Appendix 1 indicates that there is no multi active product available over the counter in the UK, for the treatment of colds, chills and influenza, which is stronger than the Nurses products. This is supported by a significant data review capturing multi-active and multi-symptom products for cold and flu and reviewing the quantities of the active ingredients in the products meeting the maximum dose as outlined by MHRA.

From this data, GSK believe that the claims ‘Nothing Stronger for Cold and Flu Relief’, ‘Unbeatable Strength for Cold and Flu Relief’, and ‘Nothing is stronger to knock out Cold and Flu’ are adequately supported.

*BNF is a publication written by the British Medical Association and the Royal Pharmaceutical Society and can be used as a reference guide for prescribing and dispensing.

**RAMA is an MHRA (Medicines and Healthcare Regulatory Agency) maintained database that documents all current granted licence details for medicinal products in the United Kingdom.

Appendix 1:Tabulated list of multi-active medicines available for purchase without prescription, for the symptoms of cold and flu

Product Legal Class Active Ingredient Quantity Maximum Dose Active Ingredient Quantity Maximum Dose Active Ingredient Quantity Maximum Dose Active Ingredient Quantity Maximum Dose
Boots Pharmacy Cold & Flu Night Capsules (1 dose is 2 tablets)/Boots Night Cold & Flu Relief CapsulesOTCParacetamol500mg1000mgPseudoephedrine hydrochloride30mg60mgPholcodine5mg10mgDiphenhydramine Hydrochloride12.5mg25mg
Covonia Cold & Flu Formula (20ml dose)OTCParacetamol1000mg1000mgPhenylephrine hydrochloride12.18mg12.18mgGuaifenesin200mg200mgCetylpyridinium chloride3mg3mg
Covonia Night Time Formula (5ml)OTCDextromethorphan Hydrobromide6.65mg6.65mgDiphenhydramine hydrochloride10mg10mgLiquid Maltitol1.125g1.125mgEthanol7.3Vol%7.3Vol%
Vicks VaporubOTCLEVOMENTHOL2.75%w/wN/ACAMPHOR5% w/w20mgEUCALYPTUS OIL1.5% w/w0.25mlTURPENTINE OIL5% w/w5% (Max. Strength)
Vicks Medinite/Vicks Cold & Flu Care MEDINITE Complete Syrup (30ml)OTCParacetamol2.0%w/v2.0%w/vPseudoephedrine hydrochloride0.2%w/v0.2%w/vDextromethorphan hydrobromide0.05%w/v0.05%w/vDoxylamine succinate0.025%w/v0.025%w/v
Boots 24 Hour Cold & Flu Relief Capsules (1 dose-2capsules)/Boots Pharmacy Cold & Flu 24 Hour Capsules - day and nightOTCParacetamol500mg1000mgPseudoephedrine hydrochloride30mg60mgPholcodine5mg10mg
OTCParacetamol500mg1000mgPseudoephedrine hydrochloride30mg60mgPholcodine5mg10mgDiphenhydramine Hydrochloride12.5mg25mg
Day & Night Nurse Capsules (2 tablets per dose)OTCParacetamol500mg1000mgPseudoephedrine hydrochloride30mg60mgPholcodine5mg10mg
OTCParacetamol500mg1000mgPromethazine Hydrochloride10mg20mgDextromethorphan Hydrobromide7.5mg15mg
Day Nurse CapsulesOTCParacetamol500mg1000mgPseudoephedrine hydrochloride30mg60mgPholcodine5mg10mg
Night Nurse CapsulesOTCParacetamol500mg1000mgPromethazine Hydrochloride10mg20mgDextromethorphan Hydrobromide7.5mg15mg
BEECHAMS Ultra All In One Capsules, Hard PL 00079/0655OTCParacetamol500mg1000mgPhenylephrine hydrochloride6.1mg12.2mgGuaifenesin100mg200mg
Beechams All-in-one Liquid/Beechams Multi-symptom relief oral solution (in 20ml dose)OTCParacetamol500mg500mgGuaifenesin200mg200mgPhenylephrine hydrochloride10mg10mg
Beechams All-in-one Tablets (in each tablet. 2 tablets per dose)OTCParacetamol250mg500mgGuaifenesin100mg200mgPhenylephrine hydrochloride5mg10mg
Night Nurse (20ml dose - liquid)OTCParacetamol1000mg1000mgPromethazine Hydrochloride20mg20mgDextromethorphan Hydrobromide15mg15mg
Day Nurse (30ml dose - liquid)OTCParacetamol1000mg1000mgPseudoephedrine hydrochloride60mg60mgPholcodine10mg10mg
NIGHT NURSE Hot Lemon Menthol Powder for Oral Solution PL 00079/0671 (1 dose=1 sachet)OTCParacetamol1000mg1000mgPromethazine Hydrochloride20mg20mgDextromethorphan Hydrobromide15mg15mg
BEECHAMS Flu-Plus Caplets / BEECHAMS Active Cold Relief Caplets; PL 00079/0335OTCParacetamol500mg1000mgPhenylephrine hydrochloride5mg10mgCaffeine25mg50mg
Benylin 4 Flu Liquid (20ml dose)OTCParacetamol1000mg1000mgPseudoephedrine hydrochloride45mg45mgDiphenhydramine hydrochloride25mg25mg
Benylin 4 Flu Tablets (2 tablets)OTCParacetamol500mg1000mgPseudoephedrine hydrochloride22.5mg45mgDiphenhydramine hydrochloride12.5mg25mg
Lemsip Max All in One Lemon/Lemsip Cough Max for Mucus Cough & Cold 1000mg/200mg/12.2mg powder for Oral Solution (powder - 1 dose is 1 sachet)OTCParacetamol1000mg1000mgPhenylephrine hydrochloride12.2mg12.2mgGuaifenesin200mg200mg
Almus Cold & Flu Day Liquid (30ml dose)/Boots Day Cold & Flu Relief Oral Solution (PL 00014/0565)OTCParacetamol1000mg1000mgPseudoephedrine hydrochloride60mg60mgPholcodine10mg10mg
Almus Cold & Flu Night Liquid/Boots Night Cold & Flu Relief Oral Solution PL 00014/0571 (30 ml dose)OTCParacetamol1000mg1000mgDiphenhydramine hydrochloride25mg25mgPholcodine10mg10mg
Boots Night Cold & Flu Relief Oral Solution (30 ml dose)OTCParacetamol1000mg1000mgDiphenhydramine hydrochloride25mg25mgPholcodine10mg10mg
Boots Pharmacy Cold & Flu Day Capsules/Boots Day Cold & Flu Relief Capsules/Nirolex Day Cold & Flu (1 dose-2 capsules)OTCParacetamol500mg1000mgPseudoephedrine hydrochloride30mg60mgPholcodine5mg10mg
Vitabiotics Cold and Flu Capsules, hard (PL 00387/0061; 1 dose=2 tablets)OTCParacetamol300mg600mgPhenylephrine hydrochloride5mg10mgCaffeine25mg50mg
PBH Cold Relief Capsules/Paracetamol Cold Relief with Decongestant (PL 00387/0061; PL 00387/0062; PL 00387/0063; 1 dose=2 tablets)OTCParacetamol300mg600mgPhenylephrine hydrochloride5mg10mgCaffeine25mg50mg
Fedril Night Cold and Flu, Oral Solution/Lloyds Pharmacy Night Cold and Flu Relief, Oral Solution/Numark Night Cold and Flu, Oral Solution/Tesco Night Cold and Flu, Oral Solution (20ml-1dose)OTCParacetamol1000mg1000mgPromethazine hydrochloride20mg20mgDextromethorphan hydrobromide15mg15mg
Cold Relief Capsules/Superdrug Paracetamol Cold Relief with Decongestant/Sudafed Blocked Nose & Headache Capsules/Non-Drowsy Decongestant with Paracetamol/Wilko Non-Drowsy Decongestant with Paracetamol/Sainsbury’s Sinus Dual Relief Capsules/Tesco Sinus Dual Relief Capsules/Teva Cold Relief Capsules/Boots Blocked Nose & Headache Relief Capsules/Health Essentials Cold Relief Capsules/ Boots Cold & Flu Relief Capsules (1 dose=2 tablets)OTCParacetamol300mg600mgPhenylephrine hydrochloride5mg10mgCaffeine25mg50mgDiphenhydramine Hydrochloride12.5mg25mg
Extra Power Pain Reliever Tablets/Extra Power Pain Reliever Caplets/Aspirin Extra Tablets/Paramed Extra Power Pain Reliever Tablets/Superdrug Extra Power Pain Reliever/Wilko Extra Power Pain Reliever Tablets/Teva Extra Power Pain Reliever Tablets (1 dose=2 tablets) PL 12063/0009; PL 16028/0147OTCParacetamol200mg400mgAspirin300mg600mgCaffeine45mg90mg
Cold Relief Capsules (PL 17907/0346; 1 dose=2 capsules) - Bristol LaboratoriesOTCParacetamol300mg600mgPhenylephrine hydrochloride5mg10mgCaffeine25mg50mg
Wockhardt Cold Relief Capsules with Decongestant/Wockhardt Sinus Dual Relief Capsules/Superdrug Non Drowsy Sinus Relief Capsules (1 dose=2 tablets) PL 29831/0173OTCParacetamol300mg600mgPhenylephrine hydrochloride5mg10mgCaffeine25mg50mg
Clear Dissolving Pain Relief Tablets (Max Remedies PL 31308/0019; 1 dose=2 tablets)OTCparacetamol powder EP250mg500mgParacetamol DC FP 272 GSR HSE260mg520mgAnhydrous caffeine30mg60mg
Maximum Flu Strength Caplets (1 dose=2 tablets) PL 29831/0436 (Wockhardt)OTCParacetamol500mg1000mgPseudoephedrine hydrochloride6mg12mgCaffeine25mg50mg
Sainsbury’s Cold Relief Capsules (PL 29831/0438; 1 dose=2 tablets)OTCParacetamol300mg600mgPseudoephedrine hydrochloride5mg10mgCaffeine25mg50mg
Benylin Day & Night Tablets/Sudafed Decongestant & Pain Tablets (1 dose = 1 tablet)OTCParacetamol500mg500mgPseudoephedrine hydrochloride60mg60mg
OTCParacetamol500mg500mgDiphenhydramine hydrochloride25mg25mg
Contac Non Drowsy Dual Relief Tablets (1 dose=2 tablets)OTCParacetamol500mg1000mgPseudoephedrine hydrochloride30mg60mg
Lemsip Max Flu Lemon (powder - 1 dose is 1 sachet)OTCParacetamol1000mg1000mgPseudoephedrine hydrochloride60mg60mg
Multi-Action Actified Tablets (1 dose = 1 tablet)OTCPseudoephedrine hydrochloride60mg60mgTripolidine hydrochloride2.5mg2.5mg
Non-Drowsy Sinutab (2 tablet = 1 dose)OTCParacetamol500mg1000mgPseudoephedrine hydrochloride30mg60mg
Nurofen Cold & Flu/Nurofen Sinus Relief (tablets - 1/2 a day 3x a day)OTCIbuprofen200mg400mgPseudoephedrine hydrochloride30mg60mg
Nurofen Cold & Flu Relief 200mg/5mg Tablets (2 tablets every 8 hours. Leave 4 hours between doses)OTCIbuprofen200mg400mgPseudoephedrine hydrochloride5mg10mg
Nurofen Day & Night Cold & Flu 200mg/5mg Tablets (2 tablets every 8 hours. Leave 4 hours between doses)OTCIbuprofen200mg400mgPseudoephedrine hydrochloride5mg10mg
Otrivine mu-cron/Boots Decongestant with Pain Relief Tablets (1 tablet, max of 4 a day)OTCParacetamol500mg500mgPseudoephedrine hydrochloride60mg60mg
Sudafed Sinus Pressure & Pain Tablets (1-2 tablets)OTCIbuprofen200mg400mgPseudoephedrine hydrochloride30mg60mg
Almus Chesty Cough Linctus with Decongestant/Boots Chesty Cough & Congestion Relief Oral Solution (1 dose=10ml)OTCPseudoephedrine hydrochloride30mg30mgGuaifenesin100mg100mg
Boots Cold & Flu Relief with Ibuprofen (2 tablets)OTCIbuprofen200mg400mgPseudoephedrine hydrochloride30mg60mg
Boots Cough and Decongestant Syrup 6 Years + (1 dose is 2x5ml spoonfuls)OTCPseudoephedrine hydrochloride0.2%w/v0.4%w/vGuaifenesin1.0%w/v2.0%w/v
Almus Dry Cough Linctus with Decongestant/Boots Dry Cough & Congestion Relief Oral Solution (5ml x 2= 1 dose)OTCPseudoephedrine hydrochloride30mg60mgDextromethorphan hydrobromide10mg20mg
Day Nurse Sinus and Pain Relief, 500 mg/ 30 mg film-coated tablet (2 tablets - 1 dose)OTCParacetamol500mg1000mgPseudoephedrine hydrochloride30mg60mg
Ibuprofen and pseudoephedrine hydrochloride 200mg/30mg film coated tablets (2 tablets = 1 dose)OTCIbuprofen200mg400mgPseudoephedrine hydrochloride30mg60mg
Lasynac 200mg/30mg film coated tablets (2 tablets = 1 dose)OTCIbuprofen200mg400mgPseudoephedrine hydrochloride30mg60mg
Orbifen Cold & Flu Oral Suspension (5ml. 20ml = 1 dose)OTCIbuprofen100mg400mgPseudoephedrine hydrochloride15mg60mg
Panadol Cold & Sinus (1 dose is 2 tablets)OTCParacetamol500mg1000mgPseudoephedrine hydrochloride30mg60mg
RobiSinus & Congestion Relief 200 mg, 30 mg Tablets (1 dose=2 tablets) Pfizer PL 00165/0391OTCIbuprofen200mg400mgPseudoephedrine hydrochloride30mg60mg
Benylin Day and Night Tablets/Sudafed Decongestant & Pain Tablets (day and night-1 tablet is 1 dose)OTCParacetamol500mg500mgPseudoephedrine hydrochloride60mg60mg
OTCParacetamol500mg500mgDiphenhydramine hydrochloride25mg25mg
Sudafed Sinus Pressure & Pain Tablets (1 dose = 2 tablets)OTCIbuprofen200mg400mgPseudoephedrine hydrochloride30mg60mg
Dozol Oral Solution (5ml. 1 dose=20ml) PL 01648/0004OTCParacetamol120mg480mgDiphenhydramine Hydrochloride12.5mg50mg
Medised for Children (5ml. 1 dose=20ml) PL 17905/0090 SSL InternationalOTCParacetamol120mg480mgDiphenhydramine Hydrochloride12.5mg50mg
Panadol Extra Advance 500 mg/65 mg Tablets (1 dose=2 tablets)OTCParacetamol500mg1000mgCaffeine65mg130mg
PANADOL Cold & Flu 500 mg/30 mg Film-Coated Tablets PL 00079/0383OTCParacetamol500mg1000mgPseudoephedrine hydrochloride30mg60mg
Nuromol 200mg/500mg tablets (1 dose=1 tablet)OTCParacetamol500mg1000mgIbuprofen6.1mg6.1mg
Mandanol Plus (1 dose=2 tablets)OTCParacetamol500mg1000mgCaffeine65mg130mg
GeloProm Oral Powder (1 dose=1 sachet) imported product name: LEMSIP MAX COLD & FLU DIRECTOTCParacetamol1000mg1000mgPhenylephrine hydrochloride12.2mg12.2mg
Flu Relief Capsules with Decongestant/Vicks Sinex Decongestant Capsules (1 tablet=1 dose)OTCParacetamol500mg500mgPhenylephrine hydrochloride12.18mg12.18mg
Co-Codamol 8mg/500mg Tablets; PL 29831/0045; 1 dose=2 tabletsOTCParacetamol500mg1000mgCodeine phosphate8mg16mg
Paracetamol and Caffeine Tablets/Moss Paracetamol Extra Strength/Safeway Paracetamol Plus Caplets/Unichem Paracetamol Extra Strength/Asda Paracetamol Extra Strength Tablets/Superdrug Paracetamol Plus (1 dose=2 tablets) PL 31308/0034OTCCoated Paracetamol 90% DC555.6mg1111.2mgCaffeine50mg100mg
RobiSinus & Congestion Relief 200 mg, 30 mg Tablets (1 dose=2 tablets) PfizerOTCIbuprofen200mg400mgPseudoephedrine hydrochloride30mg60mg
Co-codamol Effervescent Tablets 8/500mg; Fannin (UK) Ltd; (1 dose=2 tablets) PL 20417/0028OTCParacetamol500mg1000mgCodeine phosphate hemihydrate8mg16mg
Co-Codamol Tablets (Consilient Health Ltd) - (1 dose=2 tablets) PL 24837/0011; Consilient Health LtdOTCParacetamol500mg1000mgCodeine phosphate8mg16mg
Paracetamol and Caffeine 500 mg / 65 mg Tablets (1 dose=2 tablets) SmithKline Beecham t/a GSK PL 00071/0659OTCParacetamol500mg1000mgCaffeine65mg130mg
Co-Codaprin Aspirin & Codeine Tablets (Ayrton Saunders)OTCAspirin400mg800mgCodeine phosphate8mg16mg

KEY

Quantity: quantity of active ingredient in a tablet, capsule, spoonful or cap full

Maximum Dose: Representing the quantity of active ingredient per dose as indicated in Section 4.2 of the SPC.

Note The quantity of paracetamol contained within the product: ‘Paracetamol and Caffeine tablets/ Moss Paracetamol Extra Strength/Safeway Paracetamol Plus Caplets/Unichem Paracetamol Extra Strength/Asda Paracetamol Extra Strength Tablets/Superdrug Paracetamol Plus’ is 1111.2mg, however this is not above the maximum dose as the tablets are formulated of 90% paracetamol (i.e. 1000mg paracetamol) and 10% excipients.

References

MHRA Lists A, B C:

http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingofmedicines/Legalstatusandreclassification/Listsofsubstances/index.htm#l1

Joint Formulary Committee British National Formulary, Pharmaceutical Press

Chemist & Druggist Monthly Pricelist

EMC - https://www.medicines.org.uk/emc/

RAMA – accessed via the MHRA Portal. Membership required to gain access.

Date of preparation: 16-Aug-18

CHGBI/CHNRS/0033/18