Yuvafem (Page 10 of 10)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AvKARE
NDC 42291- 962 -18
Yuvafem®
(estradiol vaginal inserts, USP)
10 mcg
3 Blister packs each containing 6 vaginal inserts

(with disposable applicators)
18 Vaginal Inserts
(with disposable applicators)
Rx only

Contents:
18 vaginal inserts with disposable applicators.
Each insert contains: estradiol, USP 10 mcg; corn starch, hypromellose, lactose monohydrate and magnesium stearate.
The film coating contains hypromellose and polyethylene glycol.
Dosage:
One (1) Yuvafem insert inserted vaginally once per day for two weeks, then one (1) insert inserted twice weekly (for example, Tuesday and Friday).
Each insert is contained in a disposable single-use applicator.
Please read the Patient Package Insert for complete product information.
Dispenser:
This carton contains information intended for the patient.
This information is to be provided to the patient with each package dispensed.
Keep out of reach of children.
This package is not child-resistant.
Store at 20° to 25° (68° to 77°F); excursions permitted to 15° to 30°C

(59° to 86°F) [ see USP Controlled Room Temperature].
Do not refrigerate.

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478
Mfg. Rev. 03-2018-05 AV 03/18 N3 42291 96218 7

Label
(click image for full-size original)

Label 2
(click image for full-size original)
YUVAFEM estradiol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-962
Route of Administration VAGINAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESTRADIOL (ESTRADIOL) ESTRADIOL 10 ug
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
Product Characteristics
Color white (off-white) Score no score
Shape ROUND Size 6mm
Flavor Imprint Code AN;276
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42291-962-08 8 APPLICATOR in 1 CARTON contains a APPLICATOR (42291-962-11)
1 NDC:42291-962-11 1 TABLET in 1 APPLICATOR This package is contained within the CARTON (42291-962-08)
2 NDC:42291-962-18 18 APPLICATOR in 1 CARTON contains a APPLICATOR (42291-962-11)
2 NDC:42291-962-11 1 TABLET in 1 APPLICATOR This package is contained within the CARTON (42291-962-18)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205256 10/19/2016
Labeler — AvKARE (796560394)

Revised: 01/2020 AvKARE

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