Valacyclovir Hydrochloride (Page 8 of 8)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AvKARE NDC 42291-889-30
Valacyclovir Hydrochloride Tablets

1 g*
30 Tablets Rx Only

PHARMACIST: PLEASE DISPENSE WITH ATTACHED PATIENT INFORMATION LEAFLET.
Do not use if safety seal under cap is broken or missing.
*Each film-coated tablet contains valacyclovir hydrochloride equivalent to 1 g valacyclovir.
Usual Dosage: See package insert for full prescribing information.

Store at 20o to 25o C (68o to 77o F) [See USP Controlled Room Temperature].
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478
Mfg. Iss. 12/09
AV 05/13 (P)

N 3 42291 88930 9

label
(click image for full-size original)
VALACYCLOVIR HYDROCHLORIDE
valacyclovir hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-889(NDC:0093-7259)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VALACYCLOVIR HYDROCHLORIDE (ACYCLOVIR) VALACYCLOVIR 1 g
Inactive Ingredients
Ingredient Name Strength
POWDERED CELLULOSE
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 2
ALUMINUM OXIDE
HYPROMELLOSE 2910 (6 MPA.S)
STARCH, CORN
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
SODIUM STEARYL FUMARATE
TITANIUM DIOXIDE
Product Characteristics
Color BLUE Score 2 pieces
Shape OVAL (capsule-shaped) Size 23mm
Flavor Imprint Code 93;7259
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42291-889-30 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077655 07/11/2013
Labeler — AvKARE, Inc. (796560394)

Revised: 07/2013 AvKARE, Inc.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.