{"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=\"43%\"/> <col width=\"37%\"/> <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":"20171118","id":"544b7766-57f7-4964-866b-af0d923802b2","inactive_ingredient":["Inactive ingredients carnauba wax, crospovidone, D&C red no. 27 aluminum lake, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid, titanium dioxide"],"indications_and_usage":["Uses temporarily relieves symptoms due to hay fever, other upper respiratory allergies and the common cold"],"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 OF BENADRYL® ALLERGY Allergy Tablets Diphenhydramine Hydrochloride 25 mg Antihistamine For Allergy Relief Sneezing Itchy, watery eyes Runny nose Itchy throat 25 mg each Easy to swallow Allergy Label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Antihistamine"],"questions":["Questions? 1-800-934-1204"],"set_id":"379d9648-1143-4415-a528-3b18cddcfa9e","spl_product_data_elements":["berkley and jensen allergy Diphenhydramine Hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE CARNAUBA WAX CROSPOVIDONE (15 MPA.S AT 5%) HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOLS POLYSORBATE 80 STEARIC ACID TITANIUM DIOXIDE DIBASIC CALCIUM PHOSPHATE DIHYDRATE 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"]}