Medsafe Logo
Hide menus
Show menus

Safety Information

Revised: 13 December 2007

Cough and cold products - Information regarding use in children under 2 years of age

The Medicines Adverse Reactions Committee (MARC) reviewed the safety and efficacy of cough and cold medicines for use in children in December 2007. The Committee considered that the risk-benefit profile for the use of cough and cold medicines in children under two years is unfavourable. The review concluded that there is:

To address these concerns, Medsafe has been working together with New Zealand sponsors to amend the product packaging for cough and cold products to include the statement “Must not be used in children under two years of age”, or words to this effect.

The packaging amendments are required for all cough and cold products containing the following ingredients:

It is expected that all affected stock in retail will carry this warning by 1 May 2009.

A list of currently marketed (as of 1 March 2009) cough and cold products for which the packing is expected to include the new warning is provided in the table below.

A  B  C  D  H  L  M  O  P  R  S  T  V

Brand Name Active Ingredient

A
At-Eze - nasal spray oxymetazoline hydrochloride

B
Baxters Lung Preserver - oral solution ipecacuanha liquid extract
Baxters Tickly Cough Mixture - oral solution dextromethorphan hydrobromide monohydrate
Benadryl Chesty Forte - oral solution guaifenesin
+ bromhexine hydrochloride
Benadryl Dry Forte - oral solution dextromethorphan hydrobromide monohydrate
Benadryl Nightime - syrup dextromethorphan hydrobromide monohydrate

+ diphenhydramine hydrochloride

Bisolvon Chesty Forte - oral solution bromhexine hydrochloride
Bisolvon Chesty - tablet bromhexine hydrochloride
Bisolvon Sinus - elixir bromhexine hydrochloride
+ pseudoephedrine hydrochloride
Buckleys DM - oral solution dextromethorphan hydrobromide monohydrate

C
Cepacol Cough - lozenge dextromethorphan hydrobromide monohydrate
Codral 4 Flu - tablet
Note: name changed to Codral Original Cold & Flu Max
pseudoephedrine hydrochloride
+ chlorphenamine maleate
Codral Cold & Flu - tablet
Note: name changed to Codral Original Cold & Flu
pseudoephedrine hydrochloride
Codral Cough, Cold & Flu Day & Night - capsule
Note: name changed to Codral Original Cold & Flu + Cough
pseudoephedrine hydrochloride
+ dextromethorphan hydrobromide monohydrate
Codral Daytime/Nightime - tablet
Note: name changed to Codral Original Day & Night
pseudoephedrine
Codral Nightime Cold & Flu - tablet phenylephrine hydrochloride
+ chlorphenamine maleate
Codral Original Cold & Flu - tablet
Note: previously marketed as Codral Cold & Flu
pseudoephedrine hydrochloride
Codral Original Cold & Flu + Cough - capsule
Note: previously marketed as Codral Cough, Cold & Flu Day & Night
pseudoephedrine hydrochloride
+ dextromethorphan hydrobromide monohydrate
Codral Original Cold & Flu Max - tablet
Note: previously marketed as Codral 4 Flu
pseudoephedrine hydrochloride
+ chlorphenamine maleate
Codral Original Day & Night - tablet
Note; previously marketed as Codral Daytime/Nightime
pseudoephedrine
Coldrex Cold & Flu - tablet
Note: previously marketed as Coldrex Head Cold
pseudoephedrine hydrochloride
Coldrex Cough & Cold - tablet
Note: previously marketed as Coldrex Head & Chest Cold
dextromethorphan hydrobromide monohydrate
+ pseudoephedrine
Coldrex Day & Night - tablet
Note: previously marketed as Coldrex Day/Night
pseudoephedrine hydrochloride
+ chlorphenamine maleate
Coldrex Day/Night Tablet - tablet
Note: name changed to Coldrex Day & Night
pseudoephedrine hydrochloride
+ chlorphenamine maleate
Coldrex Head & Chest Cold - tablet
Note: name changed to Coldrex Cough & Cold
dextromethorphan hydrobromide monohydrate
+ pseudoephedrine
Coldrex Head Cold - tablet
Note: name change to Coldrex Cold & Flu
pseudoephedrine hydrochloride
Coldrex PE Cold & Flu Plus - tablet phenylephrine hydrochloride
Coldrex PE Cough, Cold & Flu - tablet phenylephrine hydrochloride
+ guaifenesin

D
Day & Night Cold & Flu + Cough Combination - capsule dextromethorphan hydrobromide monohydrate
+ phenylephrine hydrochloride
Demazin Cold Relief Blue Paediatric Oral Drops - syrup chlorphenamine maleate
+ phenylephrine hydrochloride
Demazin Cold Relief Paediatric Oral Drops, Colour Free - syrup chlorphenamine maleate
+ phenylephrine hydrochloride
Demazin Cold Relief Blue - syrup phenylephrine hydrochloride
+ chlorphenamine maleate
Demazin Cold Relief, Colour Free - syrup phenylephrine hydrochloride
+ chlorphenamine maleate
Difflam Anti-Inflammatory - lozenge pholcodine
Dimetapp 12 Hour - nasal spray oxymetazoline hydrochloride
Dimetapp Chest Congestion Paediatric Drops - syrup
Note: name changed to Dimetapp Chest Congestion Drops
guaifenesin
Dimetapp Chest Congestion Drops - syrup
Note: previously marketed as Dimetapp Chest Congestion Paediatric Drops
guaifenesin
Dimetapp Chesty Cough - elixir bromhexine hydrochloride
+ guaifenesin
Dimetapp Cough Cold & Flu Day & Night - capsule dextromethorphan hydrobromide monohydrate
+ doxylamine succinate
+ pseudoephedrine hydrochloride
Dimetapp DM Cold & Cough - elixir brompheniramine maleate
+ dextromethorphan hydrobromide monohydrate

+ phenylephrine hydrochloride

Dimetapp DM Cold & Cough, Colour Free - elixir brompheniramine maleate
+ dextromethorphan hydrobromide monohydrate

+ phenylephrine hydrochloride

Dimetapp DM Cold & Cough Drops, Colour Free - oral drops
Note: previously marketed as Dimetapp DM Cold & Cough Paediatric, Colour Free
brompheniramine maleate
+ dextromethorphan hydrobromide monohydrate

+ phenylephrine hydrochloride

Dimetapp DM Cold & Cough Paediatric, Colour Free - oral drops
Note: name changed to Dimetapp DM Cold & Cough Drops, Colour Free
brompheniramine maleate
+ dextromethorphan hydrobromide monohydrate
+ phenylephrine hydrochloride
Dimetapp Cold & Allergy - elixir brompheniramine maleate
+ phenylephrine hydrochloride
Dimetapp Cold & Allergy, Colour Free - elixir brompheniramine maleate
+ phenylephrine hydrochloride
Dimetapp Extra Strength Cold & Allergy, Colour Free - oral drops
Note: previously marketed as Dimetapp Infant, Colour Free
brompheniramine maleate
+ phenylephrine hydrochloride
Dimetapp Infant, Colour Free - oral drops
Note: name changed to Dimetapp Extra Strength Cold & Allergy, Colour Free
brompheniramine maleate
+ phenylephrine hydrochloride
Drixine Adult Metered Dose - nasal spray oxymetazoline hydrochloride
Drixine Adult - nasal spray oxymetazoline hydrochloride
Dry Tickly Cough Mixture - linctus pholcodine
Duro-Tuss Chesty Cough Liquid Regular - oral solution bromhexine hydrochloride
Duro-Tuss Chesty Cough Liquid plus Nasal Decongestant - oral solution bromhexine hydrochloride
+ pseudoephedrine hydrochloride
Duro-Tuss Cough Liquid Expectorant - syrup bromhexine hydrochloride
+ pholcodine
Duro-Tuss Dry Cough Liquid Forte - linctus pholcodine
Duro-Tuss Dry Cough Liquid Regular - linctus pholcodine
Duro-Tuss Dry Cough Liquid plus Nasal Decongestant - linctus pseudoephedrine hydrochloride
+ pholcodine
Duro-Tuss Dry Cough Orange - lozenge pholcodine
Duro-Tuss Dry Cough Lemon - lozenge pholcodine
Duro-Tuss Junior Dry Cough Liquid - linctus pholcodine

H
Histafen - elixir chlorphenamine maleate

L
Lemsip Chesty Cough Medicine - linctus guaifenesin
Logicin Rapid Relief - nasal spray oxymetazoline hydrochloride

M
Maxiclear Cold and Flu Relief - tablet phenylephrine hydrochloride
Maxiclear Hayfever and Sinus Relief - tablet phenylephrine hydrochloride
Maxiclear Sinus and Pain Relief - tablet phenylephrine hydrochloride
Maxiclear Sinus Relief - tablet phenylephrine hydrochloride

O
Otrivin Adult - nasal drops xylometazoline hydrochloride
Otrivin Adult - nasal spray xylometazoline hydrochloride
Otrivin Junior - nasal drops xylometazoline hydrochloride
Otrivin Junior - nasal spray xylometazoline hydrochloride
Otrivin Menthol Adult - nasal spray xylometazoline hydrochloride

P
Panadol Cold & Flu Max plus Decongestant - tablet phenylephrine hydrochloride
Panadol Cold & Flu Relief PE - tablet phenylephrine hydrochloride
+ dextromethorphan hydrobromide monohydrate
Panadol Flu Strength Day & Night PE - tablet phenylephrine hydrochloride
+ dextromethorphan hydrobromide monohydrate
Panadol Sinus Relief PE - tablet phenylephrine hydrochloride
Pholcodine BP - linctus pholcodine
Pholcodine Linctus BP - linctus pholcodine
Pholcodine Strong BP - linctus pholcodine

R
Robitussin Chesty Cough - oral solution guaifenesin
Robitussin Chesty Cough Forte - oral solution
Note: previously marketed as Robitussin ME Chesty Cough Forte
bromhexine hydrochloride
+ guaifenesin
Robitussin Cough & Chest Congestion - oral solution
Note: previously marketed as Robitussin DM
guaifenesin
+ dextromethorphan hydrobromide monohydrate
Robitussin DM - oral solution
Note: name changed to Robitussin Cough & Chest Congestion
guaifenesin
+ dextromethorphan hydrobromide monohydrate
Robitussin Dry Cough Forte - syrup
Note: previously marketed as Robitussin DX Dry Cough Forte
dextromethorphan hydrobromide monohydrate
Robitussin DX Dry Cough Forte - syrup
Note: name changed to Robitussin Dry Cough Forte
dextromethorphan hydrobromide monohydrate
Robitussin EX Cough - syrup guaifenesin
Robitussin ME Chesty Cough Forte - oral solution
Note: name changed to Robitussin Chesty Cough Forte
bromhexine hydrochloride
+ guaifenesin

S
Sinutab Sinus & Pain Relief - tablet pseudoephedrine hydrochloride
Sinutab Sinus Allergy & Pain Relief - tablet pseudoephedrine hydrochloride
+ chlorphenamine maleate
Strepsils Chesty Cough - syrup guaifenesin
Strepsils Dry Cough - lozenge dextromethorphan hydrobromide monohydrate
Strepsils Dry Cough - syrup dextromethorphan hydrobromide monohydrate
Strong Pholcodine Linctus BP - linctus pholcodine
Stubborn DryTickly Cough - linctus pholcodine
Sudafed PE Phenylephrine Nasal Decongestant - tablet phenylephrine hydrochloride
Sudafed PE Phenylephrine Nasal Decongestant - tablet phenylephrine hydrochloride
Sudafed PE Phenylephrine Sinus + Allergy & Pain Relief - tablet phenylephrine hydrochloride
+ chlorphenamine maleate
Sudafed PE Phenylephrine Sinus + Pain Relief - tablet phenylephrine hydrochloride
Sudafed PE Phenylephrine Sinus Day & Night Relief - tablet phenylephrine hydrochloride
Sudafed Sinus 12 Hour Relief - tablet pseudoephedrine hydrochloride
Sudafed Sinus & Nasal Decongestant - tablet pseudoephedrine hydrochloride
Sudafed Sinus + Pain Relief - tablet pseudoephedrine hydrochloride
Sudafed Sinus Day + Night Relief - tablet pseudoephedrine hydrochloride
Sudomyl - tablet pseudoephedrine hydrochloride

T
Tixylix Syrup - linctus promethazine hydrochloride
+ pholcodine

V
Vicks Dry Cough - lozenge dextromethorphan
Vicks Dry Cough - syrup dextromethorphan hydrobromide monohydrate
Vicks Formula 44 for Dry coughs - syrup dextromethorphan hydrobromide monohydrate
Vicks Formula 44 for Chesty coughs - syrup guaifenesin
Vicks Sinex 12 hour ultra fine mist - nasal spray oxymetazoline hydrochloride
0 1 2 4 5 6 7 9 [ /