{"active_ingredient":["OTC - ACTIVE INGREDIENT SECTION Miconazole nitrate 100 mg"],"dosage_and_administration":["DOSAGE & ADMINISTRATION SECTION Directions • before using this product, read the enclosed brochure for complete instructions • adults and children 12 years of age and over: • insert 1 suppository into the vagina at bedtime for 7 nights in a row • wash applicator after each use • children under 12 years of age: ask a doctor"],"effective_time":"20220504","id":"de34c460-1b3e-4f7f-e053-2a95a90aebc9","inactive_ingredient":["INACTIVE INGREDIENT SECTION hydrogenated vegetable oil base"],"indications_and_usage":["INDICATIONS & USAGE SECTION Use • treats vaginal yeast infections"],"keep_out_of_reach_of_children":["OTC - KEEP OUT OF REACH OF CHILDREN SECTION Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."],"openfda":{},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Miconazole Nitrate Vaginal Suppositories USP, 100 mg G&W NDC 0713-0197-57 7 Day Treatment Miconazole Nitrate Vaginal Suppositories USP, 100 mg Cures Most Vaginal Yeast Infections Contains 7 Vaginal Suppositories Drug Facts Active ingredient (in each vaginal suppository) Purpose Miconazole nitrate 100 mg .........................................................................................Vaginal antifungal Use • treats vaginal yeast infections 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 • 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 pharmacist 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 by this product and fail to prevent pregnancy or sexually transmitted diseases (STDs). • do not have vaginal intercourse 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, abdominal pain, fever, chills, nausea, vomiting, 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. Directions • before using this product, read the enclosed brochure for complete instructions • adults and children 12 years of age and over: • insert 1 suppository into the vagina at bedtime for 7 nights in a row • wash applicator after each use • children under 12 years of age: ask a doctor Drug Facts (continued) Other information • store at 15°-30°C (59°-86°F). Avoid heat over 30°C (86°F). • do not use if suppository wrapper is missing or damaged (each suppository is individually wrapped) Inactive ingredient hydrogenated vegetable oil base Drug Facts (continued) Questions? call 1-800-922-1038 Manufactured by: G&W Laboratories, Inc. 111 Coolidge Street South Plainfield, NJ 07080 Visit our website @ www.gwlabs.com 80% UPC N3-0713-0197-57 keyline does not print TAMPER-EVIDENT: For your safety each suppository is individually wrapped. If a suppository is unwrapped or there are signs of tampering, DO NOT USE. Packaging Carton"],"pregnancy_or_breast_feeding":["OTC - PREGNANCY OR BREAST FEEDING SECTION If pregnant or breast-feeding, ask a health professional before use"],"purpose":["OTC - PURPOSE SECTION Vaginal Antifungal"],"questions":["OTC - QUESTIONS SECTION QUESTION? call 1-800-922-1038"],"set_id":"915b373a-cfe6-f22f-602a-bb05cd3b4109","spl_product_data_elements":["Miconazole Nitrate Miconazole Nitrate HYDROGENATED COCONUT OIL MICONAZOLE NITRATE MICONAZOLE"],"storage_and_handling":["STORAGE AND HANDLING SECTION • store at 15°-30°C (59°-86°F). Avoid heat over 30°C (86°F). • do not use if suppository wrapper is missing or damaged (each suppository is individually wrapped)"],"version":"3","warnings":["WARNINGS SECTION 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 • 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 pharmacist 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 by this product and fail to prevent pregnancy or sexually transmitted diseases (STDs). • do not have vaginal intercourse 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, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge • In case of accidental ingestion, seek professional assistance or contact a poison control center immediately."]}