{"active_ingredient":["Active ingredient (in each teaspoonful (5 mL)) Diphenhydramine HCl 12.5 mg"],"ask_doctor":["Ask a doctor before use if you have • a breathing problem such as emphysema or chronic bronchitis • glaucoma • difficulty in urination due to enlargement of the prostate gland"],"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 • do not take more than 6 doses in 24 hours • mL = milliliter; FL OZ = fluid ounce • find right dose on chart below • take every 4 to 6 hours, or as directed by a doctor Age Dose adults and children 12 years and over 2 - 4 teaspoonsful (25 mg to 50 mg) children 6 to 11 years 1 - 2 teaspoonsful (12.5 mg to 25 mg) children 2 to 5 years do not use unless directed by a doctor children under 2 years do not use"],"dosage_and_administration_table":["
AgeDose
adults and children 12 years and over2 - 4 teaspoonsful (25 mg to 50 mg)
children 6 to 11 years1 - 2 teaspoonsful (12.5 mg to 25 mg)
children 2 to 5 yearsdo not use unless directed by a doctor
children under 2 yearsdo not use
"],"effective_time":"20260406","id":"32532b11-59a5-4d31-8206-5a9fc2b76f45","inactive_ingredient":["Inactive ingredients anhydrous citric acid, D&C red #33, FD&C red #40, flavors, glycerin, high fructose corn syrup, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucrose"],"indications_and_usage":["Uses • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: o runny nose o sneezing o itchy, watery eyes o itching of the nose or throat"],"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":{"application_number":["341"],"brand_name":["Diphenhydramine HCl"],"generic_name":["DIPHENHYDRAMINE HCL"],"manufacturer_name":["Preferred Pharmaceuticals Inc."],"original_packager_product_ndc":["0904-6985"],"package_ndc":["68788-8274-1"],"product_ndc":["68788-8274"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1049906"],"spl_id":["32532b11-59a5-4d31-8206-5a9fc2b76f45"],"spl_set_id":["d3f769d7-3cbb-4469-bff8-2015619ee115"],"substance_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["TC2D6JAD40"]},"package_label_principal_display_panel":["Principal display panel MAJOR® NDC 68788-8274-1 Relabeled By: Preferred Pharmaceuticals Inc. Diphenhydramine HCl Oral Solution Antihistamine 12.5 mg/5 mL Institutional Dispensing only Cherry Flavored Alcohol Free TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING 50844 REV1019A01521 Distributed by: MAJOR® PHARMACEUTICALS Livonia, MI 48152 Relabeled By: Preferred Pharmaceuticals Inc. Diphenhydramine HCl Oral Solution 12.5mg/5mL"],"package_label_principal_display_panel_table":["
Institutional Dispensing only
"],"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 Relabeled By: Preferred Pharmaceuticals Inc."],"set_id":"d3f769d7-3cbb-4469-bff8-2015619ee115","spl_product_data_elements":["Diphenhydramine HCl Diphenhydramine HCl DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE ANHYDROUS CITRIC ACID D&C RED NO. 33 FD&C RED NO. 40 GLYCERIN HIGH FRUCTOSE CORN SYRUP WATER SODIUM BENZOATE SODIUM CHLORIDE TRISODIUM CITRATE DIHYDRATE SUCROSE"],"storage_and_handling":["Other information • each teaspoonful (5 mL) contains: sodium 5 mg • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) • use by expiration date on package"],"version":"5","warnings":["Warnings Do not use • to make a child sleepy • 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 • glaucoma • difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product • avoid alcoholic beverages • alcohol, sedatives, and tranquilizers may increase drowsiness • excitability may occur, especially in children • marked drowsiness may occur • use caution when driving a motor vehicle or operating machinery If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."],"when_using":["When using this product • avoid alcoholic beverages • alcohol, sedatives, and tranquilizers may increase drowsiness • excitability may occur, especially in children • marked drowsiness may occur • use caution when driving a motor vehicle or operating machinery"]}