Miconazole 7 100 mg/1

Miconazole Nitrate · SUPPOSITORY · Strategic Sourcing Services LLC

1 Recall on Record

Plain English

Miconazole 7 is an over-the-counter vaginal suppository used to treat vaginal yeast infections. You insert one suppository vaginally each day for seven days to relieve itching, burning, and other symptoms of the infection.

Key Facts

Brand Name: Miconazole 7
Generic Name: Miconazole Nitrate
NDC Code (Product): 49348-833
Manufacturer: Strategic Sourcing Services LLC
Strength: 100 mg/1
Dosage Form: SUPPOSITORY
Route: VAGINAL
Marketing Status
Application #: ANDA073507
Marketing Start: 12/09/2011

Recall History

1 Recall on Record

Class II03/15/2021

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

vulvovaginal burning sensation568 reports

drug ineffective532 reports

condition aggravated236 reports

vulvovaginal pain206 reports

vulvovaginal pruritus180 reports

vulvovaginal discomfort149 reports

vaginal haemorrhage86 reports

off label use76 reports

vulvovaginal swelling72 reports

hypersensitivity64 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses • treats vaginal yeast infections • relieves external itching and irritation due to a vaginal yeast infection

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: • applicators: insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. Throw applicator away after use. • use the same tube of cream if you have itching and irritation on the skin outside the vagina. 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

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…

Frequently Asked Questions

What is Miconazole 7 used for?

Is Miconazole 7 a controlled substance?

Miconazole 7 is not classified as a controlled substance by the DEA.

What is the generic name for Miconazole 7?

The generic name for Miconazole 7 is Miconazole Nitrate. There are 12 other brand versions of Miconazole Nitrate.

What is the NDC code for Miconazole 7 100 mg/1?

The NDC (National Drug Code) for Miconazole 7 100 mg/1 is 49348-833, listed by Strategic Sourcing Services LLC.

Product NDC

49348-833

Package NDC

49348-833-61

Other Miconazole Brands

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

Data from openFDA · Public domain (CC0 1.0)