{"active_ingredient":["Active ingredient (in each tablet) Diphenhydramine hydrochloride 25 mg"],"ask_doctor":["Ask a doctor before use if you have • glaucoma • trouble urinating due to an enlarged 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 • with any other product containing diphenhydramine, even one used on skin • to make a child sleepy"],"dosage_and_administration":["Directions • take every 4 to 6 hours, not more than 6 doses in 24 hours adults and children 12 years of age and over 1 or 2 tablets children 6 to under 12 years of age 1 tablet children 4 to under 6 years of age do not use unless directed by a doctor children under 4 years of age do not use"],"dosage_and_administration_table":["<table width=\"100%\"> <col width=\"58%\"/> <col width=\"42%\"/> <tbody> <tr> <td styleCode=\"Botrule Lrule Toprule \" valign=\"top\"> <paragraph>adults and children 12 years of age and over</paragraph> </td> <td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"> <paragraph>1 or 2 tablets</paragraph> </td> </tr> <tr> <td styleCode=\"Lrule Botrule \" valign=\"top\"> <paragraph>children 6 to under 12 years of age</paragraph> </td> <td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"> <paragraph>1 tablet</paragraph> </td> </tr> <tr> <td styleCode=\"Lrule Botrule \" valign=\"top\"> <paragraph>children 4 to under 6 years of age</paragraph> </td> <td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"> <paragraph>do not use unless directed by a doctor</paragraph> </td> </tr> <tr> <td styleCode=\"Botrule Lrule \" valign=\"top\"> <paragraph>children under 4 years of age</paragraph> </td> <td styleCode=\"Rrule Botrule Lrule \" valign=\"top\"> <paragraph>do not use</paragraph> </td> </tr> </tbody> </table>"],"effective_time":"20171122","id":"79c09088-db45-40ff-a489-6d61c96224af","inactive_ingredient":["Inactive ingredients carnauba wax, crospovidone, D&C red no. 27 aluminum lake, dibasic calcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, starch, stearic acid, titanium dioxide"],"indications_and_usage":["Uses • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • sneezing • itchy, watery eyes • itchy nose or throat • temporarily relieves these symptoms of the common cold: • runny nose • sneezing"],"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":{},"package_label_principal_display_panel":["Principal Display Panel Compare to the active ingredient in Benadryl® Allergy See New Warning and Dosing Directions Allergy Tablets Diphenhydramine Hydrochloride 25 mg Antihistamine For Allergy Relief Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat Easy to Swallow Small Tablet Size Allergy Tablets Carton Allergy Tablets Carton Easy to Swallow Allergy Tablets Carton"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Antihistamine"],"questions":["Questions or comments? 1-800-719-9260"],"set_id":"eae23b64-c07b-48c5-b563-72eeb208fa9f","spl_product_data_elements":["allergy Diphenhydramine Hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE CARNAUBA WAX CROSPOVIDONE (15 MPA.S AT 5%) ANHYDROUS DIBASIC CALCIUM PHOSPHATE HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOLS POLYSORBATE 80 STEARIC ACID TITANIUM DIOXIDE dark L479"],"storage_and_handling":["Other information • each tablet contains: calcium 20 mg • store at 20°-25°C"],"version":"2","warnings":["Warnings Do not use • with any other product containing diphenhydramine, even one used on skin • to make a child sleepy Ask a doctor before use if you have • glaucoma • trouble urinating due to an enlarged 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 drinks • excitability may occur, especially in children • alcohol, sedatives and tranquilizers may increase drowsiness • 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 right away."],"when_using":["When using this product • marked drowsiness may occur • 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"]}