{"active_ingredient":["Active ingredient Minoxidil 5% w/v Purpose Hair regrowth treatment for men"],"ask_doctor":["Ask a doctor before use if you have heart disease"],"do_not_use":["Do not use if: • you are a woman • your amount of hair loss is different than that shown on the side of this carton or your hair loss is on the front of the scalp. 5% minoxidil topical solution is not intended for frontal baldness or receding hairline • you have no family history of hair loss • your hair loss is sudden and/or patchy • you do not know the reason for your hair loss • you are under 18 years of age. Do not use on babies and children • your scalp is red, inflamed, infected, irritated or painful • you use other medicines on the scalp"],"dosage_and_administration":["Directions: • apply one mL with dropper 2 times a day directly onto the scalp in the hair loss area • using more or more often will not improve results • continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again"],"effective_time":"20260126","id":"494a6bca-19c5-f856-e063-6294a90ab251","inactive_ingredient":["Inactive ingredients Alcohol, Propylene Glycol, Purified Water"],"indications_and_usage":["Uses to regrow hair on the top of the scalp (vertex only, see picture on side of carton)"],"keep_out_of_reach_of_children":["Keep out of reach of children. If swallowed, get medical help, or contact a Poison Control Center rightaway."],"openfda":{"application_number":["ANDA076239"],"brand_name":["OpusMeds Extra Strength Minoxidil"],"generic_name":["MINOXIDIL"],"is_original_packager":[true],"manufacturer_name":["Opus Meds LLC"],"nui":["N0000175379","N0000175564"],"package_ndc":["87338-983-00"],"pharm_class_epc":["Arteriolar Vasodilator [EPC]"],"pharm_class_pe":["Arteriolar Vasodilation [PE]"],"product_ndc":["87338-983"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["311724"],"spl_id":["494a6bca-19c5-f856-e063-6294a90ab251"],"spl_set_id":["eab00b6d-d49a-4090-8243-ae5e99f6a54e"],"substance_name":["MINOXIDIL"],"unii":["5965120SH1"]},"package_label_principal_display_panel":["Package Labeling: Outer Package Inner Package Box Box2"],"pregnancy_or_breast_feeding":["May be harmful if used when pregnant or breast-feeding."],"purpose":["Purpose Hair regrowth treatment for men"],"questions":["Questions or comments? 1-877-866-7870 • Visit Website at www.Opusmeds.com"],"set_id":"eab00b6d-d49a-4090-8243-ae5e99f6a54e","spl_product_data_elements":["OpusMeds Extra Strength Minoxidil MINOXIDIL ALCOHOL PROPYLENE GLYCOL WATER MINOXIDIL MINOXIDIL"],"spl_unclassified_section":["Drug Facts","Other information • see hair loss pictures on side of this carton • before use, read all information on carton and enclosed leaflet • keep the carton. It contains important information. • hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with 5% minoxidil topical solution for men • in clinical studies of mostly white men aged 18-49 years with moderate degrees of hair loss, 5% minoxidil topical solution for men provided more hair regrowth than 2% minoxidil topical solution • store at controlled room temperature 20º to 25ºC (68º to 77ºF)."],"stop_use":["Stop use and ask a doctor if • chest pain, rapid heartbeat, faintness, or dizziness occurs • sudden, unexplained weight gain occurs • your hands or feet swell • scalp irritation or redness occurs • unwanted facial hair growth occurs • you do not see hair regrowth in 4 months"],"version":"1","warnings":["Warnings: For external use only. For use by men only. Flammable: Keep away from fire or flame Do not use if: • you are a woman • your amount of hair loss is different than that shown on the side of this carton or your hair loss is on the front of the scalp. 5% minoxidil topical solution is not intended for frontal baldness or receding hairline • you have no family history of hair loss • your hair loss is sudden and/or patchy • you do not know the reason for your hair loss • you are under 18 years of age. Do not use on babies and children • your scalp is red, inflamed, infected, irritated or painful • you use other medicines on the scalp Ask a doctor before use if you have heart disease When using this product • do not apply on other parts of the body • avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water • some people have experienced changes in hair color and/or texture • it takes time to regrow hair. Results may occur at 2 months with twice a day usage. For some men, you may need to use this product for at least 4 months before you see results. • the amount of hair regrowth is different for each person. This product will not work for all men. Stop use and ask a doctor if • chest pain, rapid heartbeat, faintness, or dizziness occurs • sudden, unexplained weight gain occurs • your hands or feet swell • scalp irritation or redness occurs • unwanted facial hair growth occurs • you do not see hair regrowth in 4 months May be harmful if used when pregnant or breast-feeding. Keep out of reach of children. If swallowed, get medical help, or contact a Poison Control Center rightaway."],"when_using":["When using this product • do not apply on other parts of the body • avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water • some people have experienced changes in hair color and/or texture • it takes time to regrow hair. Results may occur at 2 months with twice a day usage. For some men, you may need to use this product for at least 4 months before you see results. • the amount of hair regrowth is different for each person. This product will not work for all men."]}