{"active_ingredient":[""],"ask_doctor":["Ask a Doctor before use if you have ■ a breathing problem such as emphysema or chronic bronchitis, ■ glaucoma or ■ trouble urinating due to an enlarged prostate gland"],"ask_doctor_or_pharmacist":["Ask a Doctor/Pharmacist before use if you are taking sedatives or tranquilizers"],"do_not_use":["Do Not Use with any other products containing diphenhydramine, including one applied topically"],"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 older 25 mg to 50 mg (1 to 2 caplets) Children 6 to under 12 years of age 12.5 mg** to 25 mg (1 caplet) Children under 6 years of age Consult a doctor ** A 12.5 mg dosage strength is not available in this package. (Do not attempt to break caplet)"],"dosage_and_administration_table":["<table ID=\"inv-009bca68-bad3-40e6-8896-62419f2377d0\" frame=\"border\" border=\"1\"> <col width=\"312px\"/> <col width=\"276px\"/> <thead valign=\"bottom\"> <tr valign=\"bottom\"> <td valign=\"bottom\" styleCode=\"Botrule Lrule Rrule Toprule\">Adults and children 12 years of age and older</td> <td valign=\"bottom\" styleCode=\"Botrule Rrule Toprule\">25 mg to 50 mg (1 to 2 caplets)</td> </tr> </thead> <tbody> <tr> <td styleCode=\"Botrule Lrule Rrule\"> Children 6 to under 12 years of age</td> <td styleCode=\"Botrule Rrule\"> 12.5 mg** to 25 mg (1 caplet)</td> </tr> <tr> <td styleCode=\"Botrule Lrule Rrule\"> Children under 6 years of age</td> <td styleCode=\"Botrule Rrule\"> Consult a doctor</td> </tr> </tbody> </table>"],"effective_time":"20150504","id":"f16bbbd0-ac83-4274-8376-7f669c51ac63","inactive_ingredient":["Inactive ingredients croscarmellose sodium, D&C Red #27, hydroxypropylmethyl cellulose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide"],"indications_and_usage":["USES temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: ■ sneezing ■ runny nose ■ itchy, watery eyes ■ itching of the nose or throat ■ and these symptoms associated with the common cold ■ sneezing ■ runny nose"],"keep_out_of_reach_of_children":["Keep Out of Reach of Children. In case of accidental overdose, contact a doctor or Poison Control Center immediately."],"openfda":{},"package_label_principal_display_panel":["DISPLAY PANEL AZPALLERGYREL24.jpg"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use"],"purpose":[""],"set_id":"dd45a89c-4ded-4710-8af3-047eeb26e0d2","spl_product_data_elements":["Diphenhydramine HCl Diphenhydramine HCl DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE CROSCARMELLOSE SODIUM D&C RED NO. 27 MAGNESIUM STEARATE HYPROMELLOSES AZ048"],"version":"2","warnings":["WARNINGS Do Not Use with any other products containing diphenhydramine, including one applied topically Ask a Doctor before use if you have ■ a breathing problem such as emphysema or chronic bronchitis, ■ glaucoma or ■ trouble urinating due to an enlarged prostate gland Ask a Doctor/Pharmacist before use if you are taking sedatives or tranquilizers When using this product ■ marked drowsiness may occur ■ avoid alcoholic beverages ■ 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. In case of accidental overdose, contact a doctor or Poison Control Center immediately. 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 older 25 mg to 50 mg (1 to 2 caplets) Children 6 to under 12 years of age 12.5 mg** to 25 mg (1 caplet) Children under 6 years of age Consult a doctor ** A 12.5 mg dosage strength is not available in this package. (Do not attempt to break caplet) Other information ■ store at room temperature in a dry place ■ do not use if blister package is torn Inactive ingredients croscarmellose sodium, D&C Red #27, hydroxypropylmethyl cellulose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide"],"warnings_table":["<table ID=\"inv-009bca68-bad3-40e6-8896-62419f2377d0\" frame=\"border\" border=\"1\"> <col width=\"312px\"/> <col width=\"276px\"/> <thead valign=\"bottom\"> <tr valign=\"bottom\"> <td valign=\"bottom\" styleCode=\"Botrule Lrule Rrule Toprule\">Adults and children 12 years of age and older</td> <td valign=\"bottom\" styleCode=\"Botrule Rrule Toprule\">25 mg to 50 mg (1 to 2 caplets)</td> </tr> </thead> <tbody> <tr> <td styleCode=\"Botrule Lrule Rrule\"> Children 6 to under 12 years of age</td> <td styleCode=\"Botrule Rrule\"> 12.5 mg** to 25 mg (1 caplet)</td> </tr> <tr> <td styleCode=\"Botrule Lrule Rrule\"> Children under 6 years of age</td> <td styleCode=\"Botrule Rrule\"> Consult a doctor</td> </tr> </tbody> </table>"],"when_using":["When using this product ■ marked drowsiness may occur ■ avoid alcoholic beverages ■ alcohol, sedatives, and tranquilizers may increase drowsiness ■ be careful when driving a motor vehicle or operating machinery ■ excitability may occur, especially in children"]}