{"active_ingredient":["Active ingredient (in each softgel) Diphenhydramine Hydrochloride USP 25mg"],"ask_doctor":["Ask a Doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland"],"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 do not take more than 6 doses in 24 hours adults and children 12 years and over 1 to 2 capsules children 6 to under 12 years 1 capsule children under 6 years do not use this product in children under 6 years of age"],"dosage_and_administration_table":["<table border=\"0\" width=\"100%\"><tbody><tr><td>adults and children 12 years and over</td><td>1 to 2 capsules</td></tr><tr><td>children 6 to under 12 years</td><td>1 capsule</td></tr><tr><td>children under 6 years</td><td>do not use this product in children under 6 years of age</td></tr></tbody></table>"],"effective_time":"20260427","id":"5003a7e3-9310-497a-e063-6394a90a31ea","inactive_ingredient":["Inactive Ingredients gelatin, glycerin, polyethylene glycol 400, propylene glycol, purified water, sorbitol sorbitan 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 temporarily relieves these symptoms due to the common cold: runny nose sneezing"],"keep_out_of_reach_of_children":["Keep out of reach of children. In case of overdose, get medical help or contact aPoison Control Center right away."],"openfda":{"application_number":["M012"],"brand_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"generic_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["SOFTGEL HEALTHCARE PRIVATE LIMITED"],"package_ndc":["35916-0435-1","35916-0435-3","35916-0435-4","35916-0435-5"],"product_ndc":["35916-0435"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1049909"],"spl_id":["5003a7e3-9310-497a-e063-6394a90a31ea"],"spl_set_id":["0203d919-dc1f-cca0-e063-6394a90aa1aa"],"substance_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["TC2D6JAD40"]},"package_label_principal_display_panel":["label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Antihistamine"],"set_id":"0203d919-dc1f-cca0-e063-6394a90aa1aa","spl_product_data_elements":["DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE GLYCERIN GELATIN POLYETHYLENE GLYCOL 400 PROPYLENE GLYCOL DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE SORBITOL WATER (Clear) (Oblong)"],"storage_and_handling":["Other Information store between 20° to 25°C (68° to 77°F). Avoid high humidity and excessive heat. Protect from light."],"version":"6","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"]}