Drugplain

CVS MICONAZOLE 1 COMBINATION PACK

Miconazole Nitrate · KIT · CVS PHARMACY, INC

No Recall History
Plain English

CVS MICONAZOLE 1 COMBINATION PACK is a kit containing miconazole nitrate. Manufactured by CVS PHARMACY, INC.

Key Facts

Brand Name
CVS MICONAZOLE 1 COMBINATION PACK
Generic Name
Miconazole Nitrate
NDC Code (Product)
51316-093
Manufacturer
CVS PHARMACY, INC
Dosage Form
KIT
Marketing Status
Application #
NDA021308
Marketing Start
01/30/2022

Recall History

No Recall History

Side Effects Reported to FDA

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

vulvovaginal burning sensation174 reports
drug ineffective130 reports
off label use59 reports
vulvovaginal pain59 reports
condition aggravated58 reports
drug interaction58 reports
vulvovaginal pruritus53 reports
international normalised ratio increased41 reports
constipation39 reports
pain39 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: ▪ vaginal insert: with the applicator, place the vaginal insert into the vagina. Throw away applicator. ▪ 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

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

Frequently Asked Questions

What is CVS MICONAZOLE 1 COMBINATION PACK used for?

CVS MICONAZOLE 1 COMBINATION PACK contains Miconazole Nitrate. It is a kit taken as directed. Consult your doctor for specific uses.

Is CVS MICONAZOLE 1 COMBINATION PACK a controlled substance?

CVS MICONAZOLE 1 COMBINATION PACK is not classified as a controlled substance by the DEA.

What is the generic name for CVS MICONAZOLE 1 COMBINATION PACK?

The generic name for CVS MICONAZOLE 1 COMBINATION PACK is Miconazole Nitrate. There are 12 other brand versions of Miconazole Nitrate.

What is the NDC code for CVS MICONAZOLE 1 COMBINATION PACK ?

The NDC (National Drug Code) for CVS MICONAZOLE 1 COMBINATION PACK is 51316-093, listed by CVS PHARMACY, INC.