REMEDYREPACK INC.
FULL PRESCRIBING INFORMATION: CONTENTS*
FULL PRESCRIBING INFORMATION
OTC - ACTIVE INGREDIENT
OTC - PURPOSE
USES
-
● itching of the nose or throat
WARNINGS
OTC - ASK DOCTOR
OTC - ASK DOCTOR/PHARMACIST
OTC - WHEN USING
OTC - STOP USE
OTC - PREGNANCY OR BREAST FEEDING
OTC - KEEP OUT OF REACH OF CHILDREN
DIRECTIONS
| adults and children 6 years and
over |
1 to 2 tablets once daily;
depending upon severity of symptoms; do not take more than 2 tablets in 24 hours
|
| adults 65 years and over |
1 tablet once a day; do not take
more than 1 tablet in 24 hours |
| children under 6 years of age |
ask a doctor |
| consumers with liver or kidney disease
|
ask a doctor |
STORAGE AND HANDLING
-
● Store between 20 to 25 C (68 to 77 F)
INACTIVE INGREDIENT
HOW SUPPLIED
Cetirizine Hydrochloride Tablets, USP 5 mg are supplied as white to off-white,square tablets, debossed
“APO 5mg” on obverse and plain on the reverse.
They are available as follows:
Bottles of 100: NDC 60505-2632-1
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
CETIRIZINE HYDROCHLORIDE
CETIRIZINE HYDROCHLORIDE TABLET
Product Information
|
|
Product Type
|
Human prescription drug label |
Item Code (Source)
|
NDC:49349-088(NDC:60505-2632) |
|
Route of Administration
|
ORAL |
DEA Schedule
|
|
Product Characteristics
|
|
Color
|
Size
|
Imprint Code
|
Shape
|
|
white |
6 mm |
APO;5 |
SQUARE |
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:49349-088-02 |
30 in 1 BLISTER PACK |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
ANDA |
ANDA078317 |
2010-11-23 |
|
|
