{"active_ingredient":["Active ingredients (in each 5 mL teaspoonful) Purpose Diphenhydramine Hydrochloride 12.5mg .............................Antihistamine"],"ask_doctor":["Ask a doctor before use if you have - glaucoma - 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."],"dosage_and_administration":["Directions - take every 4 to 6 hours or as directed by a doctor - do not take more then directed - mL=milliliter - find right dose on chart below Children under 2 years Do not use Children 2 to 5 years Ask a doctor Children 6 to 11 years 1-2 teaspoonful Adults and children 12 years and over 2-4 teaspoonful"],"dosage_and_administration_table":["<table width=\"100%\"> <caption/> <tbody> <tr> <td> Children under 2 years</td> <td> Do not use</td> </tr> <tr> <td> Children 2 to 5 years</td> <td> Ask a doctor</td> </tr> <tr> <td> Children 6 to 11 years</td> <td> 1-2 teaspoonful</td> </tr> <tr> <td> Adults and children 12 years and over</td> <td> 2-4 teaspoonful</td> </tr> </tbody> </table>"],"effective_time":"20250327","id":"31583c7e-3649-d899-e063-6394a90aa63f","inactive_ingredient":["Inactive ingredients citric acid, flavor, FD&C red no. 40, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol solution, sucralose."],"indications_and_usage":["Uses - sneezing - runny nose - itchy, watery eyes - itching of the nose or throat - temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:"],"keep_out_of_reach_of_children":["Keep out of reach of children."],"openfda":{"application_number":["M012"],"brand_name":["Diphenhydramine Hydrochloride"],"generic_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Oncor Pharmaceuticals"],"package_ndc":["83720-502-16","83720-502-04"],"product_ndc":["83720-502"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1049906"],"spl_id":["31583c7e-3649-d899-e063-6394a90aa63f"],"spl_set_id":["06ecba97-c790-4672-a8c3-f9caf6272d26"],"substance_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["TC2D6JAD40"],"upc":["0383720502048","0383720502161"]},"overdosage":["In case of accidental overdose, seek professional help or contact a Poison Control Center immediately."],"package_label_principal_display_panel":["Diphenhydramine (16 oz) Diphenhydramine (4 oz)"],"pregnancy":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Principal Display Panel Oncor Pharmaceuticals NDC 83720-502-16 Diphenhydramine Hydrochloride Oral Solution 12.5 mg/5 ml Antihistamine Cherry Flavor RELIEVES - Sneezing - Itchy, Watery Eyes - Runny Nose - Itchy Throat due to Allergies DO NOT USE IF TAMPER EVIDENT SEAL UNDER CAP IS BROKEN OR MISSING Alcohol Free NET WT. 16 OZ. (473 ml) NDC 83720-502-04 Diphenhydramine Hydrochloride Oral Solution 12.5 mg/5 ml Antihistamine Cherry Flavor RELIEVES - Sneezing - Itchy, Watery Eyes - Runny Nose - Itchy Throat due to Allergies DO NOT USE IF TAMPER EVIDENT SEAL UNDER CAP IS BROKEN OR MISSING Alcohol Free NET WT. 4 OZ. (118 ml) Manufactured In USA For : Oncor Pharmaceuticals 6755 Business Pkwy Suite 202 Elkridge, MD 21075 United States. Rev. 03/25"],"questions":["Questions? You may report side effects by calling Oncor Pharmaceuticals (9 a.m. to 5 p.m. EST), at 1-443-876-7600 or FDA at 1-800-FDA-1088."],"set_id":"06ecba97-c790-4672-a8c3-f9caf6272d26","spl_product_data_elements":["Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride CITRIC ACID CHERRY FD&C RED NO. 40 GLYCERIN PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE SODIUM SACCHARIN SORBITOL SOLUTION SUCRALOSE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE"],"spl_unclassified_section":[""],"storage_and_handling":["Other information - each 1 tsp (5mL) contains: sodium 4 mg - store at 59°-86°F (15°-30°C) [see USP Controlled Room Temperature]. Protect from freezing. - tamper evident by foil seal under cap. Do not use if foil seal is broken or missing."],"version":"2","warnings":["Warnings Do not use - to make a child sleepy - with any other product containing diphenhydramine, even one used on skin"],"when_using":["When using this product - marked drowsiness may occur - avoid alcoholic drinks - alcohol, sedatives, and tranquilizers may increase drowsiness - be careful when driving a motor vehicle or operating machinery - excitability may occur, especially in children"]}