{"active_ingredient":["Active ingredient (in each 5 mL) Diphenhydramine HCl USP 12.5 mg"],"ask_doctor":["Ask a doctor before use if you have glaucoma a sodium restricted diet trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers."],"do_not_use":["Do not use to make a child sleepy with any other product 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 use only with enclosed dosing cup. Do not use with any other device find right dose on chart below mL = milliliter adults and children 12 years and over 10-20mL (25 mg to 50 mg) children 6 to under 12 years 5-10mL (12.5 mg to 25 mg) children 2 to 5 years of age do not use unless directed by a doctor children under 2 years of age do not use"],"dosage_and_administration_table":["<table width=\"50%\"> <col align=\"left\" valign=\"top\" width=\"50%\"/> <col align=\"left\" valign=\"top\" width=\"50%\"/> <tbody> <tr styleCode=\"Botrule\"> <td styleCode=\"Rrule\">adults and children 12 years and over</td> <td>10-20mL (25 mg to 50 mg)</td> </tr> <tr styleCode=\"Botrule\"> <td styleCode=\"Rrule\">children 6 to under 12 years</td> <td>5-10mL (12.5 mg to 25 mg)</td> </tr> <tr styleCode=\"Botrule\"> <td styleCode=\"Rrule\">children 2 to 5 years of age</td> <td>do not use unless directed by a doctor</td> </tr> <tr> <td styleCode=\"Rrule\">children under 2 years of age</td> <td>do not use</td> </tr> </tbody> </table>"],"effective_time":"20190201","how_supplied":["HOW SUPPLIED Product: 50090-2935 NDC: 50090-2935-0 118 mL in a BOTTLE / 1 in a CARTON"],"id":"0ce14b81-98a5-45d0-a166-7f9eea190c94","inactive_ingredient":["Inactive ingredients artificial cherry flavor, citric acid, D&C Red #33, FD&C Red #40, glycerin, polysorbate 20, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol solution"],"indications_and_usage":["Uses temporarily relieves these symptoms of hay fever or other upper respiratory allergies runny nose sneezing itchy, watery eyes itching of the nose or throat"],"keep_out_of_reach_of_children":["Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)."],"openfda":{},"package_label_principal_display_panel":["Diphenhydramine HCl Label Image"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Antihistamine"],"questions":["Questions or comments? (800) 616-2471"],"set_id":"bbe3f9ed-b3b0-4d05-bcaf-6c810a65773e","spl_product_data_elements":["banophen Diphenhydramine HCl ANHYDROUS CITRIC ACID D&C RED NO. 33 FD&C RED NO. 40 WATER SODIUM BENZOATE SACCHARIN SODIUM SODIUM CITRATE, UNSPECIFIED FORM SORBITOL GLYCERIN POLYSORBATE 20 CHERRY DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE Bluish-Red"],"spl_unclassified_section":["Drug Facts","Distributed by: MAJOR ® PHARMACEUTICALS 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152"],"storage_and_handling":["Other information each (5 mL) contains: sodium 7 mg TAMPER-EVIDENT: Do not use this product if inner foil seal over the mouth of the bottle is cut, torn, broken or missing store at room temperature 20°-25°C (68°-77°F)"],"version":"3","warnings":["Warnings Do not use to make a child sleepy with any other product containing diphenhydramine, including one applied topically. Ask a doctor before use if you have glaucoma a sodium restricted diet trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis 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 use caution 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 the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)."],"when_using":["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"]}