{"active_ingredient":["A ctive i ngredient s Miconazole nitrate (200 mg in each vaginal insert) Miconazole nitrate 2% (external cream)"],"ask_doctor":["Ask a doctor before use if you have vaginal itching and discomfort for the first time lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You may have a more serious condition. vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes, or a weakened immune system. been exposed to the human immunodeficiency virus (HIV) that causes AIDS"],"ask_doctor_or_pharmacist":["Ask a doctor or p harmacist before use if you are taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur."],"do_not_use":["Do not use if you have never had a vaginal yeast infection diagnosed by a doctor ."],"dosage_and_administration":["Directions before using this product, read the enclosed consumer information leaflet for complete directions and information. adults and children 12 years of age and over: ▪ vaginal insert : with a disposable applicator, place the insert into the vagina at bedtime for three nights in a row. Throw applicator away after use. ▪ external cream : squeeze a small amount of cream onto your fingertip. Apply the cream onto the itchy, irritated skin outside the vagina. Use 2 times daily for up to 7 days, as needed. children under 12 years of age: ask a doctor."],"effective_time":"20260420","id":"9fd5cf39-5662-42fa-8d8c-8b96dce19875","inactive_ingredient":["Inactive ingredients vaginal insert: gelatin, glycerin, hydrogenated vegetable oil base, titanium dioxide external cream: benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60, potassium hydroxide, propylene glycol, purified water, stearyl alcohol"],"indications_and_usage":["Uses treats vaginal yeast infections relieves external itching and irritation due to a vaginal yeast infection"],"keep_out_of_reach_of_children":["Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["NDA020670"],"brand_name":["Monistat 3 Combination Pack 3 Ovule Inserts"],"generic_name":["MICONAZOLE NITRATE"],"is_original_packager":[true],"manufacturer_name":["Insight Pharmaceuticals LLC"],"package_ndc":["63736-019-03"],"product_ndc":["63736-019"],"product_type":["HUMAN OTC DRUG"],"rxcui":["992765","992766","992770","992771","998540","998541"],"spl_id":["9fd5cf39-5662-42fa-8d8c-8b96dce19875"],"spl_set_id":["910d81cd-67dc-4fdf-94cf-4eb3b1dca0fd"]},"other_safety_information":["Other i nformation do not use if printed sealed pouches containing vaginal inserts are torn, open or incompletely sealed do not use if seal over tube opening has been punctured do not purchase if carton is open store at 20°-25°C (68°-77°F) Keep this carton for future reference. It contains important information."],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL MONISTAT ® 3 COMBINATION PACK Miconazole Nitrate Vaginal Inserts (200 mg) and Miconazole Nitrate Vaginal Cream (2%) – Vaginal Antifungal 3 OVULE ® Inserts Net Wt. 2.5 g each + 0.32 oz (9 g) Tube MONISTAT® 3 COMBINATION PACK Miconazole Nitrate Vaginal Inserts (200 mg) and Miconazole Nitrate Vaginal Cream (2%) – Vaginal Antifungal 3 OVULE® Inserts Net Wt. 2.5 g each + 0.32 oz (9 g) Tube"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding , ask a health professional before use."],"purpose":["Purpose Vaginal antifungal Vaginal antifungal"],"questions":["Questions ? If you have any questions or comments, please call 1-877-666-4782 ."],"set_id":"910d81cd-67dc-4fdf-94cf-4eb3b1dca0fd","spl_product_data_elements":["Monistat 3 Combination Pack 3 Ovule Inserts Miconazole Nitrate Miconazole Nitrate Miconazole Nitrate Miconazole Nitrate Miconazole GELATIN GLYCERIN CORN OIL TITANIUM DIOXIDE Miconazole Nitrate Miconazole Nitrate Miconazole Nitrate Miconazole Benzoic Acid Cetyl Alcohol Isopropyl Myristate Polysorbate 60 Potassium Hydroxide Propylene Glycol Water Stearyl Alcohol"],"spl_unclassified_section":["Drug Fa c ts"],"stop_use":["Stop use and ask a doctor if: symptoms do not get better in 3 days symptoms last more than 7 days you get a rash or hives, abdominal pain, fever, chills, nausea, v omiting, or foul-smelling vaginal discharge"],"version":"5","warnings":["Warnings For vaginal use only . Do not use if you have never had a vaginal yeast infection diagnosed by a doctor . Ask a doctor before use if you have vaginal itching and discomfort for the first time lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You may have a more serious condition. vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes, or a weakened immune system. been exposed to the human immunodeficiency virus (HIV) that causes AIDS Ask a doctor or p harmacist before use if you are taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur. When using this product do not use tampons, douches, spermicides or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted diseases (STDs). do not have vaginal intercourse mild increase in vaginal burning, itching or irritation may occur if you do not get complete relief, ask a doctor before using another product Stop use and ask a doctor if: symptoms do not get better in 3 days symptoms last more than 7 days you get a rash or hives, abdominal pain, fever, chills, nausea, v omiting, or foul-smelling vaginal discharge If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away."],"when_using":["When using this product do not use tampons, douches, spermicides or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted diseases (STDs). do not have vaginal intercourse mild increase in vaginal burning, itching or irritation may occur if you do not get complete relief, ask a doctor before using another product"]}