{"active_ingredient":["active ingredients (in each tablet) Acetaminophen 500 mg Caffeine 60 mg Pyrilamine maleate 15 mg"],"active_ingredient_table":["<table border=\"0\" width=\"100%\"> <tbody> <tr> <td> <paragraph>active ingredients (in each tablet)</paragraph> <paragraph>   Acetaminophen 500 mg     Caffeine 60 mg     Pyrilamine maleate 15 mg </paragraph> </td> </tr> </tbody> </table>"],"ask_doctor":["Ask a doctor before use if you have difficulty in urination due to enlargement of the prostate gland liver disease glaucoma a breathing problem such as emphysema or chronic bronchitis"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers"],"ask_doctor_or_pharmacist_table":["<table border=\"0\" width=\"100%\"> <tbody> <tr> <td> <paragraph>Ask a doctor or pharmacist before use if you are</paragraph> <paragraph/> <paragraph/> <paragraph>taking the blood thinning drug warfarin   taking sedatives or tranquilizers </paragraph> </td> </tr> </tbody> </table>"],"ask_doctor_table":["<table border=\"0\" width=\"100%\"> <tbody> <tr> <td> <paragraph>Ask a doctor before use if you have</paragraph> <paragraph/> <paragraph/> <paragraph>difficulty in urination due to enlargement of the prostate gland   liver disease   glaucoma   a breathing problem such as emphysema or chronic bronchitis </paragraph> </td> </tr> </tbody> </table>"],"do_not_use":["Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist."],"do_not_use_table":["<table border=\"0\" width=\"100%\"> <tbody> <tr> <td> <paragraph>Do not use</paragraph> <paragraph/> <paragraph/> <paragraph>with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.</paragraph> </td> </tr> </tbody> </table>"],"dosage_and_administration":["Uses for the temporary relief of these symptoms associated with menstrual periods: cramps bloating water-weight gain headache backache breast tenderness fatigue muscle aches"],"dosage_and_administration_table":["<table border=\"0\" width=\"100%\"> <tbody> <tr> <td> <paragraph>Uses</paragraph> <paragraph/> <paragraph/> <paragraph>for the temporary relief of these symptoms associated with menstrual periods:</paragraph> <paragraph>cramps   bloating   water-weight gain   headache   backache   breast tenderness   fatigue   muscle aches </paragraph> </td> </tr> </tbody> </table>"],"effective_time":"20181214","id":"7cfef4a4-ab1d-2dd4-e053-2991aa0a56c5","inactive_ingredient":["Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, povidone, pregelatinized starch, stearic acid, titanium dioxide"],"inactive_ingredient_table":["<table border=\"0\" width=\"100%\"> <tbody> <tr> <td> <paragraph>Inactive ingredients</paragraph> <paragraph>colloidal silicon dioxide, croscarmellose sodium, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, povidone, pregelatinized starch, stearic acid, titanium dioxide</paragraph> </td> </tr> </tbody> </table>"],"indications_and_usage":["Uses for the temporary relief of these symptoms associated with menstrual periods: cramps bloating water-weight gain headache backache breast tenderness fatigue muscle aches"],"indications_and_usage_table":["<table border=\"0\" width=\"100%\"> <tbody> <tr> <td> <paragraph>Uses</paragraph> <paragraph/> <paragraph/> <paragraph>for the temporary relief of these symptoms associated with menstrual periods:</paragraph> <paragraph>cramps   bloating   water-weight gain   headache   backache   breast tenderness   fatigue   muscle aches </paragraph> </td> </tr> </tbody> </table>"],"keep_out_of_reach_of_children":["Keep out of reach of children."],"keep_out_of_reach_of_children_table":["<table border=\"0\" width=\"100%\"> <tbody> <tr> <td>Keep out of reach of children. </td> </tr> </tbody> </table>"],"openfda":{"application_number":["part343"],"brand_name":["Comfort-Time"],"generic_name":["ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE"],"is_original_packager":[true],"manufacturer_name":["Time Cap Labs, Inc"],"nui":["N0000175739","N0000175729","N0000175790","M0023046"],"package_ndc":["49483-347-24"],"pharm_class_cs":["Xanthines [CS]"],"pharm_class_epc":["Central Nervous System Stimulant [EPC]","Methylxanthine [EPC]"],"pharm_class_pe":["Central Nervous System Stimulation [PE]"],"product_ndc":["49483-347"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1597298"],"spl_id":["7cfef4a4-ab1d-2dd4-e053-2991aa0a56c5"],"spl_set_id":["e94a26a2-36e5-4e1e-aea1-24e035c98043"],"substance_name":["ACETAMINOPHEN","CAFFEINE","PYRILAMINE MALEATE"],"unii":["362O9ITL9D","3G6A5W338E","R35D29L3ZA"]},"overdosage":["WARNINGS Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 8 tablets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product"],"overdosage_table":["<table border=\"0\" width=\"100%\"> <tbody> <tr> <td> <paragraph>WARNINGS   Liver warning: </paragraph> <paragraph>This product contains acetaminophen. Severe liver damage may occur if you take:</paragraph> <paragraph>more than 8 tablets in 24 hours, which is the maximum daily amount   with other drugs containing acetaminophen   3 or more alcoholic drinks every day while using this product </paragraph> </td> </tr> </tbody> </table>"],"package_label_principal_display_panel":["tcl blister 24 tablets IMAGE OF CARTON"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"pregnancy_or_breast_feeding_table":["<table border=\"0\" width=\"100%\"> <tbody> <tr> <td> <paragraph>If pregnant or breast-feeding,</paragraph> <paragraph>ask a health professional before use.</paragraph> </td> </tr> </tbody> </table>"],"purpose":["active ingredients (in each tablet) Acetaminophen 500 mg Caffeine 60 mg Pyrilamine maleate 15 mg"],"purpose_table":["<table border=\"0\" width=\"100%\"> <tbody> <tr> <td> <paragraph>active ingredients (in each tablet)</paragraph> <paragraph>   Acetaminophen 500 mg     Caffeine 60 mg     Pyrilamine maleate 15 mg </paragraph> </td> </tr> </tbody> </table>"],"set_id":"e94a26a2-36e5-4e1e-aea1-24e035c98043","spl_product_data_elements":["Comfort-Time Acetaminophen, Caffeine, and Pyrilamine Maleate SILICON DIOXIDE CROSCARMELLOSE SODIUM CROSPOVIDONE HYPROMELLOSE 2910 (6 MPA.S) HYPROMELLOSE 2910 (15 MPA.S) MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE MINERAL OIL POVIDONE STARCH, CORN STEARIC ACID TITANIUM DIOXIDE ACETAMINOPHEN ACETAMINOPHEN CAFFEINE CAFFEINE PYRILAMINE MALEATE PYRILAMINE TCL;347"],"stop_use":["Stop use and ask a doctor if new symptoms occur redness or swelling is present pain gets worse or lasts more than 10 days"],"stop_use_table":["<table border=\"0\" width=\"100%\"> <tbody> <tr> <td> <paragraph>Stop use and ask a doctor if</paragraph> <paragraph/> <paragraph/> <paragraph>new symptoms occur   redness or swelling is present   pain gets worse or lasts more than 10 days </paragraph> </td> </tr> </tbody> </table>"],"storage_and_handling":["Other information store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F) use by expiration date on package"],"storage_and_handling_table":["<table border=\"0\" width=\"100%\"> <tbody> <tr> <td> <paragraph>Other information</paragraph> <paragraph/> <paragraph/> <paragraph>store at 25&#xB0;C (77&#xB0;F) excursions permitted between 15&#xB0;-30&#xB0;C (59&#xB0;-86&#xB0;F)   use by expiration date on package </paragraph> </td> </tr> </tbody> </table>"],"version":"3","warnings":["Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 8 tablets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product"],"warnings_table":["<table border=\"0\" width=\"100%\"> <tbody> <tr> <td> <paragraph>Warnings     Liver warning: </paragraph> <paragraph>This product contains acetaminophen. Severe liver damage may occur if you take:</paragraph> <paragraph>more than 8 tablets in 24 hours, which is the maximum daily amount   with other drugs containing acetaminophen   3 or more alcoholic drinks every day while using this product </paragraph> </td> </tr> </tbody> </table>"],"when_using":["When using this product you may get drowsy avoid alcoholic drinks excitability may occur, especially in children alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat. The recommended dose of this product contains about as much caffeine as a cup of coffee."],"when_using_table":["<table border=\"0\" width=\"100%\"> <tbody> <tr> <td> <paragraph>When using this product</paragraph> <paragraph/> <paragraph/> <paragraph>you may get drowsy   avoid alcoholic drinks   excitability may occur, especially in children   alcohol, sedatives, and tranquilizers may increase drowsiness   be careful when driving a motor vehicle or operating machinery   limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat. The recommended dose of this product contains about as much caffeine as a cup of coffee. </paragraph> </td> </tr> </tbody> </table>"]}