{"active_ingredient":["Active ingredient (in each tablet) Diphenhydramine HCl 25 mg"],"ask_doctor":["Ask a doctor before use if you have • glaucoma • a breathing problem such as emphysema or chronic bronchitis • trouble urinating due to an enlarged prostate gland"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers"],"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 tablets children 6 to under 12 years of age 1 tablet children under 6 years of age do not use this product in children under 6 years of age"],"dosage_and_administration_table":["<table> <col width=\"43%\"/> <col width=\"53%\"/> <tbody> <tr> <td styleCode=\"Rrule Botrule Toprule \"> <paragraph>adults and children 12 years of age and over</paragraph> </td> <td styleCode=\"Botrule Toprule \"> <paragraph>1 to 2 tablets</paragraph> </td> </tr> <tr> <td styleCode=\"Rrule Botrule \"> <paragraph>children 6 to under 12 years of age</paragraph> </td> <td styleCode=\"Botrule \"> <paragraph>1 tablet</paragraph> </td> </tr> <tr> <td styleCode=\"Rrule Botrule \"> <paragraph>children under 6 years of age</paragraph> </td> <td styleCode=\"Botrule \"> <paragraph>do not use this product in children under 6 years of age</paragraph> </td> </tr> </tbody> </table>"],"effective_time":"20100714","id":"59fdaf32-a7fc-4541-b402-bb03e991db24","inactive_ingredient":["Inactive ingredients corn starch, D&C red #27 aluminum lake, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide"],"indications_and_usage":["Uses • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • itchy, watery eyes • sneezing • 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. In case of overdose, get medical help or contact a Poison Control Center right away."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 25 mg NDC 51079-967-20 DIPHENHYDRAMINE HYDROCHLORIDE TABLETS 25 mg Antihistamine 100 Tablets (10 x 10) Protect from moisture. TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. Manufactured by: LNK International, Inc. Hauppauge, NY 11788 S-8806 R2 Packaged and Distributed by: UDL LABORATORIES, INC. ROCKFORD, IL 61103 This unit dose package is not child resistant. For institutional use only. Keep this and all drugs out of the reach of children. This container provides light-resistance. See window for lot number and expiration date. Diphenhydramine Hydrochloride Carton Unit Carton"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Antihistamine"],"questions":["Questions? 1-800-848-0462 • Serious side effects associated with use of this product may be reported to this number."],"set_id":"8cc11d03-7295-4ecd-9a3f-4b6998933dbf","spl_product_data_elements":["Diphenhydramine Hydrochloride diphenhydramine hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE STARCH, CORN D&C RED NO. 27 CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOLS POLYVINYL ALCOHOL SILICON DIOXIDE STEARIC ACID TALC TITANIUM DIOXIDE capsule shaped 44;329"],"spl_unclassified_section":["TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.","Other information • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. • Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] • protect from moisture • use by expiration date on blister package","HOW SUPPLIED Diphenhydramine Hydrochloride Tablets are available as follows: 25 mg - Pink film coated capsule shaped tablet imprinted with 44-329 on one side. NDC 51079-967-20 - Unit dose blister packages of 100 (10 cards of 10 tablets each). NDC 51079-967-19 - Robot Ready blister packages of 25 (25 cards of 1 tablet each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured by: LNK International, Inc. Hauppauge, NY 11788 Distributed by: UDL Laboratories, Inc. Rockford, IL 61103 S-8805 R4 7/10"],"version":"2","warnings":["Warnings Do not use • to make a child sleepy • with any other product containing diphenhydramine, even one used on skin"],"when_using":["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"]}