Revised: 13 December 2007
Safety Information
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:
- Very limited evidence for efficacy of these products in children under two years of age.
- An absence of evidence-based dosage advice for the use of cough and cold medicines in children aged less than two years.
- Evidence of harm in therapeutic use in this age group.
- Evidence of significant toxicity, including death, in overdose in this age group.
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:
- Bromhexine
- Brompheniramine
- Chlorphenamine
- Dextromethorphan
- Diphenhydramine
- Doxylamine
- Guaifenesin
- Ipecacuanha
- Oxymetazoline
- Phenylephrine
- Pholcodine
- Promethazine
- Pseudoephedrine
- Triprolidine
- Xylometazoline
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.
| 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 |
