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Yuvafem (Estradiol): Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx) Boxed warning
Strength:
10 mcg
Drug class:
Active ingredient:

Patient information: uses, side effects, how to take - Yuvafem

INSTRUCTIONS FOR USE

Yuvafem (estradiol vaginal inserts)

Read this Instructions for Use before you start using Yuvafem and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your menopausal symptoms or your treatment.

How should I use Yuvafem?

  • Yuvafem is an insert for use only in the vagina. Do not take by mouth.
  • Wash and dry your hands well before handling Yuvafem.

Step 1: Tear off a single applicator.

Step 2: Pull apart the plastic wrap and remove the applicator (see Figure A). If after opening the package you see that the Yuvafem insert has come out of the applicator but has not fallen out of the package, carefully put the insert back into the applicator for insertion.

Figure A

Step 3: Hold the applicator between your thumb and middle finger. Leave your index (pointer) finger free to press the applicator plunger (see Figure B).

Figure B

Step 4: Select the best position for vaginal insertion of Yuvafem (estradiol vaginal inserts) that is most comfortable for you. For insertion in the lying down position, see Figure C. For insertion in the standing position, see Figure D.

Figure C

Figure D

Step 5: Gently insert the end of the applicator into your vagina as far as it will comfortably go or until half of the applicator is inside your vagina, whichever is less. Do not use force. If the insert falls out of the applicator before insertion, throw away (dispose of) the insert and applicator. Get a new applicator.

Step 6: While holding the applicator in place, gently press the applicator plunger with your index (pointer) finger until it stops, to release the insert into your vagina. The insert will dissolve.

Step 7: Gently remove the applicator from your vagina and throw away (dispose of) after use. Insertion may be done at any time of the day. It is advisable to use the same time daily for all applications of Yuvafem (estradiol vaginal inserts). If you have any questions, please ask your healthcare provider or pharmacist.

How should I store Yuvafem?

  • Store Yuvafem at room temperature between 68ºF to 77ºF (20ºC to 25ºC).
  • Do not refrigerate.

Keep Yuvafem and all medicines out of the reach of children.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Distributed by:

Amneal Pharmaceuticals LLC

Bridgewater, NJ 08807

Rev. 01-2024-01

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: ANDA 205256 · View the label on DailyMed

Revision date stated in the text: January 2024

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Yuvafem

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Boxed warning Yes – this drug has a boxed warning (also called a black box warning), the strongest warning of the FDA.
Drug class Estrogen
Active ingredient Estradiol 10 mcg
Dosage form Tablet
Route Vaginal
Marketing status listed in the FDA NDC Directory
Company (applicant) AMNEAL PHARMS
FDA approval ANDA 205256Abbreviated New Drug Application (ANDA) – generic drug Approved May 29, 2015
Therapeutic equivalence (TE) code ABCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Manufacturers 2 labelers list this drug on DailyMed
Packages (NDC)
Package
10 mcg – 1 in 1 applicator / 8 in 1 carton NDC 65162-226-21
10 mcg – 1 in 1 applicator / 18 in 1 carton NDC 65162-226-23

Source: FDA drug labeling via NLM DailyMed, data as of November 6, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.