Cetirizine Tablets
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Generic Name: cetirizine hydrochloride
Dosage Form: tablet, film coated
Drug Facts
Active ingredient (in each tablet)
Cetirizine hydrochloride 10 mg
Purpose
Antihistamine
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
OTC - DO NOT USE SECTION
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.
OTC - ASK DOCTOR SECTION
Ask a doctor before use if youhave liver or kidney disease. Your doctor should determine if you need a different dose.
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.
OTC - WHEN USING SECTION
When using this product
- drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery.
OTC - STOP USE SECTION
Stop use and ask a doctor if an allergic reation to this product occurs. Seek medical help right away.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding:
- if breast-feeding: not recommended.
- if pregnant: ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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 |
Other Information
store between 20° to 25°C (68° to 77°F).
Inactive ingredients
corn starch, lactose monohydrate, povidone, magnesium stearate and opadry white.
The components of opadry white are: hydroxypropyl methylcellulose, polyethylene glycol 400, titanium dioxide.
Questions or comments?
call toll free 1-866-562-4590
SPL UNCLASSIFIED SECTION
Manufactured for: Northstar Rx LLC
Memphis, TN 38141
Manufactured by: Orchid Healthcare
(A Division of Orchid Chemicals & Pharmaceuticals Ltd.)
Irungattukottai - 602 105, India
I07/09
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 16714-271-02
Cetirizine Hydrochloride Tablets 10 mg
ALLERGY
Antihistamine
24 Hour Relief of
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
DO NOT USE IF IMPRINTED FOIL INNER SEAL ON BOTTLE IS BROKEN OR MISSING
NORTHSTAR
100 Tablets
NDC 16714-271-03
Cetirizine Hydrochloride Tablets 10 mg
ALLERGY
Antihistamine
24 Hour Relief of
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
DO NOT USE IF IMPRINTED FOIL INNER SEAL ON BOTTLE IS BROKEN OR MISSING
NORTHSTAR
300 Tablets
| CETIRIZINE HYDROCHLORIDE cetirizine hydrochloride tablet, film coated |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA078862 | 10/19/2009 | |
| Labeler - Northstar Rx LLC (830546433) |
| Registrant - Orchid Chemicals & Pharmaceuticals Ltd (650133507) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Orchid Healthcare (a division of Orchid Chemicals & Pharmaceuticals Ltd) | 650288850 | analysis, manufacture | |
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