{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-08-11",
    "results": {
      "skip": 0,
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  "results": [
    {
      "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"
      ],
      "active_ingredient": [
        "Active ingredient (in each spray) Epinephrine 0.125 mg"
      ],
      "purpose": [
        "Purpose Bronchodilator"
      ],
      "indications_and_usage": [
        "Uses for temporary relief of mild symptoms of intermittent asthma ■ wheezing ■ tightness of chest ■ shortness of breath"
      ],
      "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."
      ],
      "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."
      ],
      "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)"
      ],
      "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."
      ],
      "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"
      ],
      "pregnancy_or_breast_feeding": [
        "If pregnant or breast-feeding , ask a health care professional before use"
      ],
      "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."
      ],
      "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."
      ],
      "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."
      ],
      "inactive_ingredient": [
        "Inactive ingredients dehydrated alcohol (1%), hydrofluoroalkane (HFA 134a), polysorbate 80, thymol"
      ],
      "questions": [
        "Questions or comments? call 1-8 Primatene or 1-877-462-8363 Mon.- Fri. 7 am - 5 pm PST"
      ],
      "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"
      ],
      "set_id": "95011f7e-51be-4851-80a6-a7e9c6cad82a",
      "id": "20996512-5726-4ffe-a471-1696250913f2",
      "effective_time": "20260616",
      "version": "6",
      "openfda": {
        "application_number": [
          "NDA205920"
        ],
        "brand_name": [
          "Primatene Mist"
        ],
        "generic_name": [
          "EPINEPHRINE INHALATION"
        ],
        "manufacturer_name": [
          "Armstrong Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "17270-5512",
          "17270-5530"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "RESPIRATORY (INHALATION)"
        ],
        "substance_name": [
          "EPINEPHRINE"
        ],
        "rxcui": [
          "2109083",
          "2109088"
        ],
        "spl_id": [
          "20996512-5726-4ffe-a471-1696250913f2"
        ],
        "spl_set_id": [
          "95011f7e-51be-4851-80a6-a7e9c6cad82a"
        ],
        "package_ndc": [
          "17270-5530-0",
          "17270-5512-0"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000000209",
          "N0000000245",
          "N0000175552",
          "N0000175555",
          "N0000175570",
          "M0003647"
        ],
        "pharm_class_moa": [
          "Adrenergic alpha-Agonists [MoA]",
          "Adrenergic beta-Agonists [MoA]"
        ],
        "pharm_class_epc": [
          "alpha-Adrenergic Agonist [EPC]",
          "beta-Adrenergic Agonist [EPC]",
          "Catecholamine [EPC]"
        ],
        "pharm_class_cs": [
          "Catecholamines [CS]"
        ],
        "unii": [
          "YKH834O4BH"
        ]
      }
    }
  ]
}