ETHNOPHARMACOLOGICAL RELEVANCE: Xiao'er Feike Granules (XFG), containing eighteen incompatibilities, is an approved and widely used classical Chinese medicine prescription for the treatment of pediatric respiratory diseases. Extensive clinical studies have reported that XFG demonstrates high efficacy and minimal adverse reactions in treating acute bronchitis (AB). However, there is an urgent need for a more cohesive evaluation of the evidence regarding the safe clinical use of XFG for AB. A clearer and more systematic summary of relevant randomized controlled trials (RCTs) is necessary to assess the overall efficacy and safety of XFG. AIM OF THE STUDY: To assess the efficacy and safety of XFG for oral administration in treating AB. MATERIALS AND METHODS: RCTs comparing XFG (experimental group) with traditional Western medicine (TWM, control group) for the treatment of AB were collected by searching three English databases and four Chinese databases up to December 31, 2023. A meta-analysis was conducted by using RevMan 5.4 software, and potential publication bias was assessed by using Stata 12.0. A Grading of Recommendations Assessment, Development, and Evaluation (GRADE) evidence profile was constructed to evaluate the certainty of the evidence. RESULTS: A total of 2482 children were enrolled in 20 RCTs. The results of the meta-analysis indicated that XFG in combation with TWM is more effective than TWM alone in reducing the disappearance time of cough [MD = -1.92 days, 95% CI (-2.36, -1.47), I CONCLUSION: XFG provides benefits to children with AB regarding its effectiveness and does not increase the safety risks associated with TWM treatment. However, well-designed clinical trials are still essential. TRIAL REGISTRATION: PROSPERO registration number: CRD42023415479.