miconazole 3

Miconazole nitrate · KIT · H E B

1 Recall on Record

Plain English

miconazole 3 is a kit containing miconazole nitrate. Manufactured by H E B.

Key Facts

Brand Name: miconazole 3
Generic Name: Miconazole nitrate
NDC Code (Product): 37808-242
Manufacturer: H E B
Dosage Form: KIT
Marketing Status
Application #: ANDA075329
Marketing Start: 03/14/2006

Recall History

1 Recall on Record

Class II05/29/2013

Lowlite Investments, Inc. D/B/A Olympia Pharmacy

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

OngoingVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

vulvovaginal burning sensation890 reports

drug ineffective718 reports

condition aggravated324 reports

vulvovaginal pain320 reports

vulvovaginal pruritus261 reports

vulvovaginal discomfort204 reports

vaginal haemorrhage120 reports

vulvovaginal swelling113 reports

off label use102 reports

hypersensitivity84 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses • treats vaginal yeast infections

Dosage & 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: • insert 1 applicatorful into the vagina at bedtime for 3 nights in a row. Throw applicator away after use. • children under 12 years of age: ask a doctor

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 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…

Frequently Asked Questions

What is miconazole 3 used for?

miconazole 3 contains Miconazole nitrate. It is a kit taken as directed. Consult your doctor for specific uses.

Is miconazole 3 a controlled substance?

miconazole 3 is not classified as a controlled substance by the DEA.

What is the generic name for miconazole 3?

The generic name for miconazole 3 is Miconazole nitrate. There are 12 other brand versions of Miconazole nitrate.

What is the NDC code for miconazole 3 ?

The NDC (National Drug Code) for miconazole 3 is 37808-242, listed by H E B.

Product NDC

37808-242

Package NDC

37808-242-00

Other Miconazole Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)