On March 22, NMPA’s official website issued the “Announcement of the State Food and Drug Administration on Amending the Instructions of Pediatric Anti-phlegm and Anti-Cough Preparations”, requiring prescription drugs and OTC two kinds of children’s anti-phlegm and anti-cough preparations On the instruction manual, “adverse reactions”, “contraindications” and “precautions” should be revised uniformly.
Among them, in the instructions of the prescription drug of the anti-phlegm and anti-cough preparations for children, it is required to add “adverse reactions”: vomiting, nausea, diarrhea, abdominal pain, rash, itching, sweating, dizziness, headache, allergy Reaction, etc.; “Contraindications” item added “Forbidden for those allergic to the ingredients contained in this product”; “Precautions” added: 1. This product contains ephedrine hydrochloride;2. Athletes should use it with caution; 3. Use with caution in children with heart disease; 4. People with spleen deficiency and diarrhea should be used with caution.
In the revised requirements for over-the-counter similar drugs, the items “adverse reactions” and “contraindications” are the same as those for prescription drugs. However, in the “Precautions”, in addition to the above 4 items, there are also 9 other items of attention such as “the symptoms are not relieved after taking the medicine for 3 days, you should go to the hospital”, a total of 13 items.
According to the “Announcement”, all marketing licensees producing pediatric anti-phlegm and anti-cough preparations must revise the instructions and report to the provincial drug administration department for record before June 17. Drugs produced from the date of filing shall not continue to use the original drug inserts.
Pediatric phlegm-relieving and cough-relieving agent is a commonly used medicine for children. It is produced by many domestic pharmaceutical companies, such as Sunflower Pharmaceutical, Jianmin Group, Taiji Group, Shenwei Pharmaceutical< /strong>And other enterprises, mostly “Children Huatan Zhike Granules”. According to regulations, these drugs will need to modify the instructions.
(Picture from Visual China)