{"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=\"1\" 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":"20260127","id":"47b56686-42d6-15f1-e063-6294a90a2742","inactive_ingredient":["Inactive Ingredients FD & C blue no.1, FD & C red no.40, 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 a Poison 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":["35916-0436-2"],"product_ndc":["35916-0436"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1049909"],"spl_id":["47b56686-42d6-15f1-e063-6294a90a2742"],"spl_set_id":["32074a31-326b-4aaf-e063-6394a90a0d40"],"substance_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["TC2D6JAD40"]},"other_safety_information":["Other Information store between 20° to 25°C (68° to 77°F). Avoid high humidity and excessive heat. Protect from light. do not use if carton is open or blister unit is broken"],"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":"32074a31-326b-4aaf-e063-6394a90a0d40","spl_product_data_elements":["DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE GELATIN GLYCERIN POLYETHYLENE GLYCOL 400 PROPYLENE GLYCOL SORBITOL WATER DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE FD&C RED NO. 40 FD&C BLUE NO. 1 Transparent Oblong"],"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"]}