Cetirizine Hydrochloride
Cetrizine HCL Tablet 10 mg
FULL PRESCRIBING INFORMATION: CONTENTS*
- Active ingredient (in each tablet)
- Purpose
- Cetirizine Hydrochloride Uses
- Warnings
- Directions
- Cetirizine Hydrochloride Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL -
FULL PRESCRIBING INFORMATION
Drug Facts
Active ingredient (in each tablet)
Cetirizine HCl 10 mg
Purpose
Antihistamine
Cetirizine Hydrochloride Uses
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
Warnings
Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.
Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.
- drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
If pregnant or breast-feeding:
- if breast-feeding; not recommended
- if pregnant; ask a health professional before use
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
| adults and children 6 years and over | one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms |
| adults 65 years and over | ask a doctor |
| children under 6 years of age | ask a doctor |
| consumers with liver or kidney disease | ask a doctor |
Cetirizine Hydrochloride Other information
- store between 20° and 25°C (68° - 77°F)
Inactive ingredients
Lactose Monohydrate, microcrystalline cellulose, starch (corn), magnesium stearate, hypromellose, polydextrose, polyethylene glycol, and titanium dioxide.
Questions or comments?
To Report an Adverse Event call 1-800-616-2417
Distributed By
MAJOR PHARMACEUTICALS
31778 Enterprise Drive
Livonia, MI 48150, USA
PRINCIPAL DISPLAY PANEL -
MAJOR PHARMACEUTICALS. NDC 0904-5852-61
Cetirizine 10 mg
Cetirizine Hydrochloride Tablets
Antihistamine/Original Prescription Strength
Indoor & Outdoor Allergies
24 hour
Relief of
- Sneezing
- Runny Nose
- Itchy, Watery Eyes
- Itchy Throat or Nose
Keep the Carton. It contains important information. See end panel for expiration date.
*This product is not manufactured or distrubuted by McNeil-PPC, Inc., distributor of Zyrtec®. Zyrtec® is a registered trademark of UCB Pharma, S.A.
Cetirizine Hydrochloride
Product Information
Product Type
Human otc drug label
Item Code (Source)
NDC:0904-5852(NDC:60505-2633)
Route of Administration
ORAL
DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name
Basis of Strength
Strength
CETIRIZINE HYDROCHLORIDE CETIRIZINE
10 mg
Inactive Ingredients
Ingredient Name
Strength
lactose monohydrate
cellulose, microcrystalline
STARCH, CORN
MAGNESIUM STEARATE
HYPROMELLOSES
POLYDEXTROSE
POLYETHYLENE GLYCOL 3350
titanium dioxide
Product Characteristics
Color
Size
Imprint Code
Shape
WHITE
9 mm
10MG;APO
RECTANGLE
Packaging
#
Item Code
Package Description
Marketing Start Date
Marketing End Date
1
NDC:0904-5852-41
14 in 1 BOTTLE
2
NDC:0904-5852-43
45 in 1 BOTTLE
3
NDC:0904-5852-46
30 in 1 BOTTLE
4
NDC:0904-5852-60
100 in 1 BOTTLE
5
NDC:0904-5852-61
100 in 1 BLISTER PACK
6
NDC:0904-5852-89
90 in 1 BOTTLE
Marketing Information
Marketing Category
Application Number or Monograph Citation
Marketing Start Date
Marketing End Date
ANDA
ANDA078317
2007-12-27
