FDA label 1f7872bc-b91c-44ce-bf48-9bee528b5d02

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
1cdfb143-cdcf-4f49-8d41-7e28ceaec829
SPL ID
1f7872bc-b91c-44ce-bf48-9bee528b5d02
Version
2
Effective date
2017-11-14
Source export date
2026-09-28
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:23:03

Boxed warning cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Boxed warning sections page 1 of 1 · 1 matching rows.

boxed warning

How Should I Use This Product? This product is for adults and children 12 years of age and over. For children under 12 years, ask a doctor. Directions for using the 3 Vaginal Suppositories: Begin treatment before going to bed: 1 Tear off one suppository from the strip. Separate the plastic wrap with your thumb. With thumb and forefinger on each hand, hold the plastic tabs and pull apart (see picture). 2 Place suppository in the top of the applicator so it will not fall out. 3 Hold the applicator containing the suppository by the opposite end from where the suppository is located. 4 Gently insert the applicator into the vagina as far as it will go comfortably. This can be done while lying on your back with your knees bent (as shown in picture), or while standing with your feet apart and knees bent. 5 With one hand holding the barrel, use the other hand to push the plunger all the way in to place the suppository as far back in the vagina as possible. Then remove both parts of the applicator from the vagina. 6 REUSABLE APPLICATOR: Be sure to clean the applicator after each use. Gently pull apart the applicator pieces. Wash them with soap and warm water. To rejoin, gently push the inside piece into the ribbed end of the outside piece as far as it will go. DISPOSABLE APPLICATORS: Throw away applicator after use. Do not flush in toilet. 7 Lie down as soon as possible after inserting the suppository. This will reduce leakage. 8 Repeat steps 1-7 before bedtime for the next 2 days. You may want to use deodorant-free pads or pantyshields to protect your clothing during the time that you are using this product. This is because the suppository can leak or you may get some discharge. Do not use tampons, douches, spermicides, condoms or diaphragms until after you have completed the treatment and your symptoms are gone. Image 1 Image 2 Image 3 Image 4

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

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 a prescription blood thinning medicine, such as 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 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 right away.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.