{"active_ingredient":["Active ingredient (in each spray) Epinephrine 0.125 mg"],"ask_doctor":["Ask a doctor before use if you have ■ ever been hospitalized for asthma ■ heart disease ■ high blood pressure ■ diabetes ■ trouble urinating due to an enlarged prostate gland ■ thyroid disease ■ seizures ■ narrow angle glaucoma"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are ■ taking prescription drugs for asthma, obesity, weight control, depression, or psychiatric or emotional conditions ■ taking any drug that contains phenylephrine, pseudoephedrine, ephedrine, or caffeine (such as for allergy, cough-cold, or pain)"],"do_not_use":["Do not use ■ unless a doctor said you have asthma ■ if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs taken for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or a pharmacist before taking this product."],"dosage_and_administration":["Directions ■ read the Consumer Information Insert for detailed directions on how to use this product ■ do not use more than directed ■ for adults and children 12 years of age and over ■ children under 12 years of age: do not use; it is not known if the drug works or is safe in children under 12 Before first use (new inhaler) activate new inhaler by shaking then spraying into air 4 separate times each time you dose ■ remove red cap (if attached) ■ shake then spray into the air 1 time ■ exhale completely, place inhaler in mouth ■ inhale deeply while pressing down on top of inhaler, then continue the deep breath ■ hold breath as long as possible, exhale ■ wait 1 minute. If symptoms not relieved, take a second inhalation by repeating steps above. after use ■ wait at least 4 hours between doses ■ do not use more than 8 inhalations in 24 hours ■ wash inhaler after each day of use. Run water through the mouthpiece for 30 seconds."],"effective_time":"20260616","id":"20996512-5726-4ffe-a471-1696250913f2","inactive_ingredient":["Inactive ingredients dehydrated alcohol (1%), hydrofluoroalkane (HFA 134a), polysorbate 80, thymol"],"indications_and_usage":["Uses for temporary relief of mild symptoms of intermittent asthma ■ wheezing ■ tightness of chest ■ shortness of breath"],"keep_out_of_reach_of_children":["Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["NDA205920"],"brand_name":["Primatene Mist"],"generic_name":["EPINEPHRINE INHALATION"],"is_original_packager":[true],"manufacturer_name":["Armstrong Pharmaceuticals, Inc."],"nui":["N0000000209","N0000000245","N0000175552","N0000175555","N0000175570","M0003647"],"package_ndc":["17270-5530-0","17270-5512-0"],"pharm_class_cs":["Catecholamines [CS]"],"pharm_class_epc":["alpha-Adrenergic Agonist [EPC]","beta-Adrenergic Agonist [EPC]","Catecholamine [EPC]"],"pharm_class_moa":["Adrenergic alpha-Agonists [MoA]","Adrenergic beta-Agonists [MoA]"],"product_ndc":["17270-5512","17270-5530"],"product_type":["HUMAN OTC DRUG"],"route":["RESPIRATORY (INHALATION)"],"rxcui":["2109083","2109088"],"spl_id":["20996512-5726-4ffe-a471-1696250913f2"],"spl_set_id":["95011f7e-51be-4851-80a6-a7e9c6cad82a"],"substance_name":["EPINEPHRINE"],"unii":["YKH834O4BH"]},"package_label_principal_display_panel":["Primatene MIST® Carton Principal Display Panel Text: Primatene MIST® Epinephrine Inhalation Aerosol 0.125 mg per spray Bronchodilator For Oral Inhalation Only For TEMPORARY relief of MILD symptoms of INTERMITTENT asthma Suspension: Shake then Spray into the air before each inhalation. This item is electronically protected NEW FORMULATION: See Important Usage Information on Insert and on Side Panels 160 Metered Sprays Net Weight: 11.7g carton","Primatene MIST® Carton Principal Display Panel Text: Primatene MIST® Epinephrine Inhalation Aerosol 0.125 mg per spray Bronchodilator For Oral Inhalation Only For TEMPORARY relief of MILD symptoms of INTERMITTENT asthma Suspension: Shake then Spray into the air before each inhalation. This item is electronically protected NEW FORMULATION: See Important Usage Information on Insert and on Side Panels 160 Metered Sprays Net Weight: 11.7g carton2"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding , ask a health care professional before use"],"purpose":["Purpose Bronchodilator"],"questions":["Questions or comments? call 1-8 Primatene or 1-877-462-8363 Mon.- Fri. 7 am - 5 pm PST"],"set_id":"95011f7e-51be-4851-80a6-a7e9c6cad82a","spl_product_data_elements":["Primatene Mist Epinephrine Inhalation EPINEPHRINE EPINEPHRINE ALCOHOL NORFLURANE POLYSORBATE 80 THYMOL Primatene Mist Epinephrine Inhalation EPINEPHRINE EPINEPHRINE ALCOHOL NORFLURANE POLYSORBATE 80 THYMOL"],"stop_use":["Stop use and ask a doctor if ■ your asthma is getting worse (see asthma alert) ■ you have difficulty sleeping ■ you have a rapid heart beat ■ you have tremors, nervousness, or seizure"],"storage_and_handling":["Other information ■ store at room temperature, between 15-25°C (59-77°F) ■ contains no sulfites ■ keep this label and enclosed materials. They contain important additional information."],"version":"6","warnings":["Warnings For oral inhalation only Asthma alert: Because asthma may be life threatening, see a doctor if you ■ are not better in 20 minutes ■ get worse ■ need more than 8 inhalations in 24 hours ■ have more than 2 asthma attacks in a week These may be signs that your asthma is getting worse. Do not use ■ unless a doctor said you have asthma ■ if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs taken for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or a pharmacist before taking this product. Ask a doctor before use if you have ■ ever been hospitalized for asthma ■ heart disease ■ high blood pressure ■ diabetes ■ trouble urinating due to an enlarged prostate gland ■ thyroid disease ■ seizures ■ narrow angle glaucoma Ask a doctor or pharmacist before use if you are ■ taking prescription drugs for asthma, obesity, weight control, depression, or psychiatric or emotional conditions ■ taking any drug that contains phenylephrine, pseudoephedrine, ephedrine, or caffeine (such as for allergy, cough-cold, or pain) When using this product ■ your blood pressure or heart rate may go up. This could increase your risk of heart attack or stroke, which may cause death. ■ your risk of heart attack or stroke increases if you: ■ have a history of high blood pressure or heart disease ■ take this product more frequently or take more than the recommended dose. ■ avoid foods or beverages that contain caffeine ■ avoid dietary supplements containing ingredients reported or claimed to have a stimulant effect ■ avoid spraying in eyes ■ contents under pressure. Do not puncture or incinerate. ■ do not store near open flame or heat above 120°F (49°C). May cause bursting. Stop use and ask a doctor if ■ your asthma is getting worse (see asthma alert) ■ you have difficulty sleeping ■ you have a rapid heart beat ■ you have tremors, nervousness, or seizure If pregnant or breast-feeding , ask a health care professional before use Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."],"when_using":["When using this product ■ your blood pressure or heart rate may go up. This could increase your risk of heart attack or stroke, which may cause death. ■ your risk of heart attack or stroke increases if you: ■ have a history of high blood pressure or heart disease ■ take this product more frequently or take more than the recommended dose. ■ avoid foods or beverages that contain caffeine ■ avoid dietary supplements containing ingredients reported or claimed to have a stimulant effect ■ avoid spraying in eyes ■ contents under pressure. Do not puncture or incinerate. ■ do not store near open flame or heat above 120°F (49°C). May cause bursting."]}