{"active_ingredient":["Active ingredient (in each tablet) Diphenhydramine HCl 25 mg"],"dosage_and_administration":["Directions • take every 4 to 6 hours, or as directed by a doctor • do not take more than 6 times in 24 hours adults and children 12 years and over 1 to 2 tablets children 6 to under 12 years 1 tablet children under 6 years do not use"],"dosage_and_administration_table":["<table width=\"50%\"><colgroup><col width=\"70%\" align=\"left\" valign=\"middle\"/><col width=\"30%\" align=\"left\" valign=\"middle\"/></colgroup><tbody><tr styleCode=\"Botrule First\"><td styleCode=\"Lrule Rrule\" align=\"left\"> adults and children 12 years and over</td><td styleCode=\"Rrule\" align=\"left\"> 1 to 2 tablets</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" align=\"left\"> children 6 to under 12 years</td><td styleCode=\"Rrule\" align=\"left\"> 1 tablet</td></tr><tr><td styleCode=\"Lrule Rrule\" align=\"left\"> children under 6 years</td><td styleCode=\"Rrule\" align=\"left\"> do not use</td></tr></tbody></table>"],"effective_time":"20250102","id":"452adf86-1162-449c-a974-469bfaa20da9","inactive_ingredient":["Inactive ingredients croscarmellose sodium, dicalcium phosphate DT, D&C red #27, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, 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 • itching of the nose or throat • temporarily relieves these symptoms due to the common cold: • runny nose • sneezing"],"keep_out_of_reach_of_children":["Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms."],"openfda":{"application_number":["M012"],"brand_name":["Allergy Relief Caplet"],"generic_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["TOPCO ASSOCIATES LLC"],"package_ndc":["36800-937-40","36800-937-01"],"product_ndc":["36800-937"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1049630"],"spl_id":["452adf86-1162-449c-a974-469bfaa20da9"],"spl_set_id":["126c05e7-2cd9-47d3-96c3-82305714e1db"],"substance_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["TC2D6JAD40"],"upc":["0036800163263"]},"package_label_principal_display_panel":["Packaging image description"],"purpose":["Purpose Antihistamine"],"questions":["Questions or comments: Call 1-888-423-0139"],"set_id":"126c05e7-2cd9-47d3-96c3-82305714e1db","spl_product_data_elements":["Allergy Relief Caplet Diphenhydramine Hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE CROSCARMELLOSE SODIUM DIBASIC CALCIUM PHOSPHATE DIHYDRATE D&C RED NO. 27 MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED SILICON DIOXIDE TALC TITANIUM DIOXIDE S2"],"spl_unclassified_section":["Drug Facts","COMPARE TO BENADRYL ® ALLERGY ULTRATAB ® ACTIVE INGREDIENT* TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION *This product is not manufactured or distributed by Johnson & Johnson Consumer Inc. owner of the registered trademark Benadryl® Allergy ULTRATAB®. DISTRIBUTED BY TOPCO ASSOCIATES LLC ITASCA, IL 60143 ©TOPCO STVA1023 topcare@topco.com www.topcarebrand.com PRODUCT OF INDIA QUALITY GUARANTEED"],"storage_and_handling":["Other information • store between 20-25°C (68-77°F) • avoid excessive heat, cold and humidity • close cap tightly after use"],"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 • a breathing problem such as emphysema or chronic bronchitis • glaucoma • trouble urinating due to an enlarged prostate gland 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 • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery • excitability may occur, especially in children If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms."]}