{"active_ingredient":["Active ingredient (in each banded capsule) Diphenhydramine Hydrochloride 25 mg"],"dosage_and_administration":["Directions -Take every 4 to 6 hours – do not take more than 6 doses in 24 hours adults and children 12 years of age and over 1 to 2 capsules children 6 years to under 12 years of age 1 capsule children under 6 years of age Do not use"],"dosage_and_administration_table":["<table width=\"100%\"><col width=\"49%\"/><col width=\"49%\"/><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 to 2 capsules</paragraph></td></tr><tr><td styleCode=\"Lrule Botrule \" valign=\"top\"><paragraph>children 6 years to under 12 years of age</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>1 capsule</paragraph></td></tr><tr><td styleCode=\"Lrule Botrule \" valign=\"top\"><paragraph>children under 6 years of age</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Do not use</paragraph></td></tr><tr><td colspan=\"2\" styleCode=\"Rrule Botrule Lrule \" valign=\"top\"/></tr></tbody></table>"],"effective_time":"20231120","id":"3a561e67-75b5-4bc1-9c25-dd1812a9ce64","inactive_ingredient":["Inactive ingredients D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, Gelatin, Lactose and Starch"],"indications_and_usage":["Uses- Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies and common cold- sneezing - runny nose - itchy, watery eyes - itchy throat and nose. When using this product: • Marked drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • use caution when driving a motor vehicle or operating machinery • excitability may occur, especially in children"],"keep_out_of_reach_of_children":["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 Diphenhydramine HCl Capsules 25 mg 10 Capsules bag label"],"purpose":["Purpose Antihistamine"],"set_id":"30de8b4e-fe79-4de8-81b9-985c6e8be2c3","spl_product_data_elements":["Diphenhydramine HCl Diphenhydramine HCl DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE D&C RED NO. 28 FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN, UNSPECIFIED LACTOSE, UNSPECIFIED FORM STARCH, CORN CPC;835"],"storage_and_handling":["Storage Store at 20-25 C (68-77 F); excursions permitted to 15-30 C (59-86 F). [See USP Controlled Room Temperature]. -protect from moisture -contains lactose Questions or comments? (800) 616-2471 Distributed by MAJOR® PHARMACEUTICALS 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152 MFGD By CPC, NY 11788 Distributed By: Cardinal Health Dublin, OH 43017 L36150280122"],"version":"10","warnings":["Warnings Do not use – to make a child sleepy – with any other products containing diphenhydramine, including one applied topically Ask a doctor before use if you have –glaucoma -a breathing problem such as emphysema or chronic bronchitis –difficulty in urination due to enlargement of the prostate gland This unit dose package is not child resistant and is intended for institutional use only. Keep out of the reach of children. Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. If pregnant or breast-feeding, ask a health professional before use. In case of overdose, get medical help or contact a Poison Control Center right away. DO NOT USE IF BLISTER UNIT IS BROKEN"]}