{"active_ingredient":["Active ingredient (in each caplet) Diphenhydramine HCl 25 mg"],"ask_doctor":["Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland glaucoma"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers"],"do_not_use":["Do not use in children under 12 years of age with any other product containing diphenhydramine, even one used on skin"],"dosage_and_administration":["Overdose warning: In case of overdose get medical help or contact a Poison Control Center right away. Directions adults and children 12 years and over take 2 caplets at bedtime if needed or as directed by a doctor children under 12 years do not use"],"dosage_and_administration_table":["<table width=\"75%\"> <col width=\"50%\" align=\"left\" valign=\"top\"/> <col width=\"50%\" align=\"left\" valign=\"top\"/> <tbody> <tr styleCode=\"Botrule\"> <td>adults and children 12 years and over</td> <td styleCode=\"Lrule\">take 2 caplets at bedtime if needed or as directed by a doctor</td> </tr> <tr> <td>children under 12 years</td> <td styleCode=\"Lrule\">do not use</td> </tr> </tbody> </table>"],"effective_time":"20100203","id":"8841b9a3-1a06-4828-9eef-bec7331b6206","inactive_ingredient":["Inactive ingredients carnauba wax, cellulose, croscarmellose sodium dibasic calcium phosphate, FD&C blue #1, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, titanium dioxide"],"indications_and_usage":["Use relief of occasional sleeplessness"],"keep_out_of_reach_of_children":["Keep out of reach of children."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 25 mg Label DIPHENHYDRAMINE HCL TABLETS 25 mg BLUE Each Film coated Tablet Contains: DIPHENHYDRAMINE HCL 25 MG Lot No : Jar No. : MFG. DATE : Quantity : 100,000 Tablets Exp. Date : NDC. No : 65437-037-10 WARNING : KEEP OUT OF THE REACH OF CHILDREN STORE CONTROLLED ROOM TEMPRATURE OF 59° –86°F (15° – 30°C) PROTECT FROM LIGHT, MOISTURE AND FREEZING THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY. CONTENTS SHOULD BE APPROVED,REPACKAGED IMMEDIATELY AND LABELED IN STRICT CONFORMANCE WITH THE FDA AND REGULATIONS THEREUNDER MANUFACTURED BY: MANUFACTURED CODE No Guj/Drugs/G/1362 LABELER CODE # 14803 MANUFACTURED FOR: HIMPRIT PHARMACHEM PVT. LTD \"LAKULISH\", R.V.DESAI ROAD, NEXT TO NAVAPURA POLICE STATION BARODA, INDIA – 390 001 CAUTION : \"FOR MANUFACTURING, PROCESSING OR REPACKING\" Principal Display Panel"],"package_label_principal_display_panel_table":["<table width=\"75%\"> <col width=\"15%\" align=\"left\" valign=\"top\"/> <col width=\"15%\" align=\"left\" valign=\"top\"/> <col width=\"15%\" align=\"left\" valign=\"top\"/> <col width=\"15%\" align=\"left\" valign=\"top\"/> <col width=\"15%\" align=\"left\" valign=\"top\"/> <col width=\"25%\" align=\"left\" valign=\"top\"/> <tbody> <tr styleCode=\"Toprule\"> <td>Lot No</td> <td>:</td> <td/> <td/> <td>Jar No.</td> <td>:</td> </tr> <tr> <td>MFG. DATE</td> <td>:</td> <td/> <td/> <td>Quantity</td> <td>: 100,000 Tablets</td> </tr> <tr styleCode=\"Botrule\"> <td>Exp. Date</td> <td>:</td> <td/> <td/> <td>NDC. No</td> <td>: 65437-037-10</td> </tr> </tbody> </table>"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Nighttime sleep aid"],"set_id":"d46fff27-1a0f-42b8-b247-d2d9d4d17ac7","spl_product_data_elements":["DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE CELLULOSE, MICROCRYSTALLINE SILICON DIOXIDE ANHYDROUS DIBASIC CALCIUM PHOSPHATE CROSCARMELLOSE SODIUM MAGNESIUM STEARATE POLYETHYLENE GLYCOL POLYVINYL ALCOHOL TITANIUM DIOXIDE WATER D&C RED NO. 27 CAPSULE-SHAPED S5"],"spl_unclassified_section":["Drug Facts"],"stop_use":["Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness."],"storage_and_handling":["Other information each caplet contains: calcium 20 mg store between 20-25°C (68-77°F) do not use if carton is opened or blister unit is broken see side panel for lot number and expiration date"],"version":"1","warnings":["Warnings Do not use in children under 12 years of age 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 trouble urinating due to an enlarged prostate gland glaucoma Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product avoid alcoholic drinks drowsiness will occur do not drive a motor vehicle or operate machinery Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children."],"when_using":["When using this product avoid alcoholic drinks drowsiness will occur do not drive a motor vehicle or operate machinery"]}