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

  • High value
  • Evidence B
  • Buys life
  • For: Child under 3
  • Free
  • Takes minutes
  • No willpower

In plain words

The National Medical Products Administration (国家药监局) required 14 combination cold medicines for children to carry a warning: parents are advised not to give them to children under 2 on their own, and they should be used only under the guidance of a doctor or pharmacist. In trials in children, cough medicines and antihistamines (allergy drugs) worked no better than placebo.

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 under 2; 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. 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. 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