{"active_ingredient":["Active ingredient (in each teaspoonful (5 mL)) Diphenhydramine HCl USP 12.5 mg"],"ask_doctor":["Ask a docter before use if you have glaucoma trouble urinating due to an enlarged prostate gland a sodium-restricted diet 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, even one used on skin."],"dosage_and_administration":["Directions take every 4 to 6 hours find right dose on chart below do not take more than 6 doses in 24 hours adults and children 12 years and over 2 - 4 teaspoonsful (25 mg to 50 mg) children 6 to under 12 years 1 - 2 teaspoonsful (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 width=\"50%\" align=\"left\" valign=\"top\"/> <col width=\"50%\" align=\"left\" valign=\"top\"/> <tbody> <tr styleCode=\"Botrule\"> <td styleCode=\"Rrule\">adults and children 12 years and over</td> <td>2 - 4 teaspoonsful (25 mg to 50 mg)</td> </tr> <tr styleCode=\"Botrule\"> <td styleCode=\"Rrule\">children 6 to under 12 years</td> <td>1 - 2 teaspoonsful (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":"20190925","id":"9362aa10-fbe0-0ce0-e053-2995a90a6186","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 due to 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":["PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label NDC 0904-5174-16 BANOPHEN™ ORAL SOLUTION Sugar-Free Alcohol-Free Cherry Flavor (Diphenhydramine HCl, USP) Each teaspoonful (5 mL) contains: Diphenhydramine Hydrochloride, USP 12.5 mg TAMPER-EVIDENT: Do not use this product if inner foil seal over the mouth of the bottle is cut, torn, broken or missing. This Large Size Is For Dispensing Purpose Only Distributed by MAJOR ® PHARMACEUTICALS 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152 ONE PINT (473 mL) MAJOR ® PHARMACEUTICALS Principal Display Panel - 473 mL Bottle Label"],"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":"9f40ea06-bd0b-4db8-91d6-774f65a7f345","spl_product_data_elements":["Banophen diphenhydramine hydrochloride SODIUM CITRATE, UNSPECIFIED FORM SORBITOL FD&C RED NO. 40 GLYCERIN POLYSORBATE 20 CHERRY WATER SODIUM BENZOATE SACCHARIN SODIUM D&C RED NO. 33 ANHYDROUS CITRIC ACID DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE"],"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 teaspoonful (5 mL) contains: sodium 7 mg store between 20°-25°C (68°-77°F)"],"version":"4","warnings":["Warnings Do not use to make a child sleepy with any other product containing diphenhydramine, even one used on skin. Ask a docter before use if you have glaucoma trouble urinating due to an enlarged prostate gland a sodium-restricted diet 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"]}