Miconazole 7

openFDA label record#

Cross-check layer: This is openFDA JSON-derived label data. Use the corresponding DailyMed SPL as the canonical label.

Brand name
Miconazole 7
Generic name
MICONAZOLE NITRATE
Manufacturer
Family Dollar (FAMILY WELLNESS)
Product type
HUMAN OTC DRUG
SPL set ID
c0249750-551a-4ab3-b5f1-409957889c8e
SPL ID
5f34aa8e-e9e8-445d-8a32-4cefa889aa0d
Version
5
Effective date
2026-03-16
Source export date
2026-08-01
Applications, Product NDCs, Package NDCs table
ApplicationsProduct NDCsPackage NDCsRxCUIsUNIIsRoutes
ANDA07416455319-57355319-573-15998540VW4H1CYW1KVAGINAL

Warnings cross-check#

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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 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 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, 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 (1-800-222-1222) right away.