For children under 2 with colds, don’t give them over-the-counter multi-ingredient cold and cough medicines on your own

The National Medical Products Administration requires a warning on 14 kinds of combination cold medicines for children. The warning says it does not recommend that a parent give the medicine to a child under 2 on their own. It should be used with a doctor or a pharmacist guiding it. In trials done on children, cough medicines and anti-allergy medicines worked no better than a placebo (a dummy pill).

Cost

There is no cost at all; you even save money by not buying these medicines.

Benefit

In its Announcement No. 57 of 2021, the National Medical Products Administration updated the instructions for 14 such medicines, including paracetamol, pseudoephedrine and dextromethorphan oral solution, pediatric paracetamol, artificial cow-bezoar and chlorpheniramine maleate granules, and pediatric paracetamol and amantadine hydrochloride granules. The new warning reads: “It is not recommended for parents or guardians to give these products to infants under 2 years old on their own; they should only be used under the guidance of a doctor or pharmacist.” An additional note was added: “These products must be used strictly according to the dosage instructions on the package to avoid overdosing.” Another note states: “Concurrent use of other cold medicines containing the same or similar active ingredients should be avoided.” A Cochrane systematic review included 29 randomized controlled trials, 10 of which were conducted on children. For all these medicine types, no better effect than placebo was observed in pediatric trials: cough medicines, antihistamines (the anti-allergy component), antihistamines combined with decongestants (the ingredient that relieves nasal congestion), and cough medicines combined with bronchodilators. Adverse reactions were reported in 21 studies, with formulations containing antihistamines and dextromethorphan showing a higher incidence of side effects.

Notes

Many of these 14 medicines have “paracetamol” in their name, as they contain acetaminophen. Taking them together with other fever reducers will lead to redundant intake, as noted in Section 1 of this chapter (on acetaminophen). One trial included in the review found honey to be more effective than placebo for treating coughs, but honey should not be given to children under 1 year old, as detailed in Section 20, Item 6 (on honey). The evidence grade is set to B because there are very few trials for each type of medicine in the review, and the authors could not calculate a combined statistical figure. The benefit level is rated “moderate” as there is no proven benefit of these medicines for children, while the main risks are overdosing and redundant intake of similar active ingredients.

Sources · 2

1. 国家药监局关于修订氨酚麻美口服溶液等14个品种药品说明书的公告（2021年第57号）及附件. nmpa.gov.cn/directory/web/nmpa/xxgk/ggtg/ypgg…
2. Smith SM, Schroeder K, Fahey T (2014). Over-the-counter (OTC) medications for acute cough in children and adults in community settings. Cochrane Database of Systematic Reviews, (11):CD001831. doi.org/10.1002/14651858.CD001831.pub5