{"active_ingredient":["Active ingredient (in each tablet) Ephedrine HCl 12.5 mg"],"ask_doctor":["Ask a doctor before use if you have ever been hospitalized for asthma heart disease high blood pressure diabetes thyroid disease seizures narrow angle glaucoma a psychiatric or emotional condition trouble urinating due to an enlarged prostate gland"],"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 pharmacist before taking this product. if you have ever had an allergic reaction to this product or any of its ingredients"],"dosage_and_administration":["Directions do not take more than directed adults and children 12 years and over: take 1-2 tablets every 4 hours as needed. Do not take more than 12 tablets in 24 hours. children under 12 years of age: do not use"],"effective_time":"20241107","id":"2657d074-46cb-bc95-e063-6294a90aeec8","inactive_ingredient":["Inactive ingredients D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium starch glycolate, stearic acid"],"indications_and_usage":["Use 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":["M012"],"brand_name":["Primatene"],"generic_name":["EPHEDRINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Foundation Consumer Brands"],"package_ndc":["80070-600-24","80070-600-60"],"product_ndc":["80070-600"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["2534871","2591390"],"spl_id":["2657d074-46cb-bc95-e063-6294a90aeec8"],"spl_set_id":["2170f081-c03f-47e8-bc63-4052c5e653fa"],"substance_name":["EPHEDRINE HYDROCHLORIDE"],"unii":["NLJ6390P1Z"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 12.5 mg Tablet Blister Pack Carton NEW FORMULA Primatene ® TABLETS Ephedrine HCl 12.5 mg • Bronchodilator For the Temporary Relief of Mild Symptoms of INTERMITTENT ASTHMA 24 TABLETS PRINCIPAL DISPLAY PANEL - 12.5 mg Tablet Blister Pack Carton"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Bronchodilator"],"questions":["Questions or comments? Call 1-800-535-0026 weekdays 9 AM to 5 PM EST"],"set_id":"2170f081-c03f-47e8-bc63-4052c5e653fa","spl_product_data_elements":["Primatene EPHEDRINE HYDROCHLORIDE SILICON DIOXIDE DIBASIC CALCIUM PHOSPHATE DIHYDRATE D&C YELLOW NO. 10 ALUMINUM LAKE FD&C YELLOW NO. 6 MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID EPHEDRINE HYDROCHLORIDE EPHEDRINE Light yellow color PT;in;circle;engraved"],"spl_unclassified_section":["Drug Facts","Distributed by: Foundation Consumer Brands, LLC Pittsburgh, PA 15212"],"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 20-25°C (68-77°F)"],"version":"2","warnings":["Warnings Asthma alert Because asthma may be life threatening, see a doctor if you are not better in 60 minutes get worse need more than 12 tablets in 24 hours use more than 8 tablets in 24 hours for 3 or more days a week have more than 2 asthma attacks in a week These may be signs that your asthma is getting worse. This product will not give you asthma relief as quickly as an inhaled bronchodilator. 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 pharmacist before taking this product. if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have ever been hospitalized for asthma heart disease high blood pressure diabetes thyroid disease seizures narrow angle glaucoma a psychiatric or emotional condition trouble urinating due to an enlarged prostate gland 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 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 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"]}