Do not give a child under two a combination cold or cough medicine without professional guidance
China's National Medical Products Administration requires warnings on 14 combination cold medicines for children: parents should not independently give them to children under two, and use should be guided by a doctor or pharmacist. In the pediatric trials reviewed, cough suppressants and antihistamines did not work better than placebo.
What it takes
Nothing; it can also save the cost of unnecessary medicine.
What you may gain
Announcement No. 57 of 2021 from China's National Medical Products Administration revised labeling for 14 products, including acetaminophen/pseudoephedrine/dextromethorphan oral solution, pediatric acetaminophen/artificial calculus bovis/chlorpheniramine granules, and pediatric acetaminophen/amantadine granules. The added warning advises parents and guardians against giving the products to children under two without a doctor or pharmacist's guidance. Precautions require following the labeled dose and administration instructions strictly to avoid overdose, and avoiding combinations with other cold medicines containing the same or similar active ingredients. A Cochrane systematic review included 29 randomized controlled trials, ten involving children. In the pediatric trials, cough suppressants, antihistamines, antihistamine/decongestant combinations, and cough suppressant/bronchodilator combinations did not outperform placebo. Antihistamines are allergy medicines; decongestants relieve a blocked nose. Twenty-one studies reported adverse effects, which were more frequent with preparations containing antihistamines or dextromethorphan.
Context & considerations
Many of these 14 products have 氨酚 in their Chinese names and contain acetaminophen. Adding a fever reducer can duplicate the ingredient; see entry 34-1. One trial in the review found honey better than placebo, but honey must not be given to children under one; see entry 20-6. The evidence is rated B because there were few trials of each drug class and the reviewers did not pool results into a single effect estimate. The medium benefit rating is a judgment: these medicines have no established benefit for children in the cited trials, while the main risks are overdose and duplicated ingredients.
Research & references
China's National Medical Products Administration, Announcement on Revisions to the Labeling of 14 Products Including Acetaminophen/Pseudoephedrine/Dextromethorphan Oral Solution (No. 57 of 2021), with attachments. https://www.nmpa.gov.cn/directory/web/nmpa/xxgk/ggtg/ypggtg/ypshmshxdgg/20210423105404141.html; 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. https://doi.org/10.1002/14651858.CD001831.pub5