Don't give a child aged 2 or younger combination cold medicines or cough medicines on your own for a cold

Cost

Free, and it saves the money you would spend on medicine.

What you get

Announcement No. 57 of 2021 from the National Medical Products Administration revised the inserts of 14 products, including “氨酚麻美口服溶液”, “小儿氨酚黄那敏颗粒” and “小儿氨酚烷胺颗粒” (all pediatric combination cold medicines). The new warning reads: “Parents or guardians are advised not to use this product on their own for infants and toddlers aged 2 or younger; it should be used under the guidance of a doctor or pharmacist.” The precautions added: “Strictly follow the directions and dose in the insert, and avoid overdose.” They also added: “Avoid combining anti-cold drugs that contain the same or similar active ingredients.” A Cochrane systematic review included 29 randomized controlled trials, 10 of them in children. In the trials in children, none of these kinds of drugs was better than placebo: cough suppressants, antihistamines (allergy ingredients), antihistamines plus decongestants (ingredients that clear the nose), and cough suppressants plus bronchodilators. 21 studies reported adverse effects, and preparations containing an antihistamine and dextromethorphan had more of them.

Notes

Many of these 14 have names containing “氨酚” (ānfēn, short for acetaminophen), so they contain acetaminophen (paracetamol), and taking them together with a fever reducer doubles up; see §34.1 (acetaminophen). One trial in that review found honey better than placebo, but honey must not be given under age 1; see §20.6 (honey). Graded B because the review had few trials for each class of drug and the authors did not pool a number. The benefit is rated “medium” as a judgment: these drugs have no proven benefit for small children, and the risk is mainly overdose and duplicated ingredients.

Evidence grade

B : Supported by research but without a precise number, or based on small or single studies.

Sources

1. National Medical Products Administration Announcement on revising the package inserts of 14 products including acetaminophen-pseudoephedrine-dextromethorphan oral solution (No. 57 of 2021), with annexes [in Chinese]. https://www.nmpa.gov.cn/directory/web/nmpa/xxgk/ggtg/ypggtg/ypshmshxdgg/20210423105404141.html
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. https://doi.org/10.1002/14651858.CD001831.pub5

Translated from the Chinese original. Original book, section 34, tip 4. This section is about health and medicines. It is general information, not a substitute for a doctor’s diagnosis or prescription. Content may be out of date and rules differ by place. When you actually deal with an agency, a doctor or a court, follow what local officials, doctors and lawyers tell you. Disclaimer