{"active_ingredient":["Active ingredient (in each banded capsule) Diphenhydramine Hydrochloride 50 mg"],"ask_doctor":["Ask a doctor before use if you have glaucoma difficulty in urination due to enlargement of the prostate gland a breathing problem such as emphysema or chronic bronchitis"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers."],"do_not_use":["Do not use to make a child sleepy with any other product containing diphenhydramine, even one used on skin"],"dosage_and_administration":["Directions take every 4 to 6 hours do not take more than 6 doses in 24 hours Age Dose adults and children 12 years and over 1 to 2 capsules children 6 to under 12 years of age 1 capsule children under 6 years of age do not use this product in children under 6 years of age"],"dosage_and_administration_table":["<table width=\"350px\"><colgroup><col/><col/></colgroup><tbody><tr><td styleCode=\"Botrule Lrule Rrule Toprule\"><content styleCode=\"bold\">Age</content></td><td styleCode=\"Botrule Lrule Rrule Toprule\"><content styleCode=\"bold\">Dose</content></td></tr><tr><td styleCode=\"Botrule Lrule Rrule Toprule\">adults and children 12 years and over</td><td styleCode=\"Botrule Lrule Rrule Toprule\">1 to 2 capsules</td></tr><tr><td styleCode=\"Botrule Lrule Rrule Toprule\">children 6 to under 12 years of age</td><td styleCode=\"Botrule Lrule Rrule Toprule\">1 capsule</td></tr><tr><td styleCode=\"Botrule Lrule Rrule Toprule\" rowspan=\"2\">children under 6 years of age</td><td styleCode=\"Botrule Lrule Rrule Toprule\" rowspan=\"2\">do not use this product in children under 6 years of age</td></tr></tbody></table>"],"effective_time":"20230226","id":"d89d316b-1d9b-451d-9502-a90a92e5b9bb","inactive_ingredient":["Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hard gelatin capsules, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, propyl paraben sodium."],"indications_and_usage":["Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat"],"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 (1-800-222-1222) right away."],"openfda":{},"package_label_principal_display_panel":["50mg"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Antihistamine"],"questions":["Questions or comments? Call toll-free 1-877-225-6999 Mfg Lic .No: TN/DRUGS/558/1997 Manufactured for: Akron Pharma, Inc, 373 RT US 46 W, Building E, Suite 117, Fairfield, NJ 07004"],"set_id":"aa8e72b9-ae59-4563-b3c7-9d48d0cc2c52","spl_product_data_elements":["Diphenhydramine HCl Diphenhydramine HCl DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE SILICON DIOXIDE CROSCARMELLOSE SODIUM GELATIN HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE PROPYLPARABEN SODIUM light pink AP;26"],"storage_and_handling":["Other information store at temperature 15° to 30° C (59° to 86°F) do not use if either capsule band or imprinted safety seal under cap is broken or missing protect from moisture"],"version":"5","warnings":["Warnings Do not use to make a child sleepy with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if you have glaucoma difficulty in urination due to enlargement of the prostate gland a breathing problem such as emphysema or chronic bronchitis Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product marked drowsiness may occur avoid alcoholic beverages alcohol, sedatives, and tranquilizers may increase drowsiness excitability may occur, especially in children be careful when driving a motor vehicle or operating machinery 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 (1-800-222-1222) right away."],"when_using":["When using this product marked drowsiness may occur avoid alcoholic beverages alcohol, sedatives, and tranquilizers may increase drowsiness excitability may occur, especially in children be careful when driving a motor vehicle or operating machinery"]}