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The safety and effectiveness of Ventolin HFA in children under 4 years of age has not been established. The results of these studies did not establish the efficacy of Ventolin HFA in this age-group [see Pediatric Use (8. Table 1 lists the incidence of all adverse reactions (whether considered by the investigator to be related or unrelated to drug) from these studies that occurred at a rate of 3% or greater in the group treated with Ventolin HFA and more frequently in the group treated with Ventolin HFA than in the HFA-134a placebo inhaler group. Ventolin HFA is also supplied as an 8-g pressurized aluminum canister with dose counter fitted with a blue plastic actuator and a blue strapcap; this canister contains 60 actuations. The data from adults and adolescents is based upon 2 clinical trials in which 202 patients with asthma 12 years of age and older were treated with Ventolin HFA 2 inhalations 4 times daily for 12 weeks’ duration. Caution should be exercised when Ventolin HFA is administered to a nursing woman.
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