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The safety and effectiveness of Ventolin HFA in children under 4 years of age has not been established. Discard Ventolin HFA when the counter reads 000 or 6 months after removal from the moisture-protective foil pouch, whichever comes first [see Dosage Forms and Strengths (3)]. Because of the potential for tumorigenicity shown for albuterol in animal studies and lack of experience with the use of Ventolin HFA by nursing mothers, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Ventolin HFA is supplied as an 18-g pressurized aluminum canister with dose counter fitted with a blue plastic actuator and a blue strapcap; this canister contains 200 actuations. Three studies have been conducted to evaluate the safety and efficacy of Ventolin HFA in patients under 4 years of age and the findings are described below.
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