FDA Label for Cetirizine Hydrochloride
View Indications, Usage & Precautions
- ACTIVE INGREDIENT IN EACH CHEWABLE TABLET
- PURPOSE
- USES
- WARNINGS
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING
- KEEP OUT OF THE REACH OF CHILDREN
- DIRECTIONS
- INACTIVE INGREDIENTS
- QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Cetirizine Hydrochloride Product Label
The following document was submitted to the FDA by the labeler of this product Novel Laboratories, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient In Each Chewable Tablet
For 5 mg:
Cetirizine hydrochloride 5 mg
For 10 mg:
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
Do not use if you have ever had an allergic reactions 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.
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
Stop Use And Ask 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 The Reach Of Children
In case of overdose, get medical help or contact a Poison Control Center right away at (1-800-222-1222).
Directions
- may be taken with or without water
- store between 20° to 25°C (68° to 77°F)
- Do not use if individual blister unit is open or torn
For Cetirizine Hydrochloride Chewable Tablets, 5 mg
| adults and children 6 years
| 1 to 2 tablets once daily depending upon severity of symptoms; do not take
|
| and over
| 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
| ask a doctor
|
| age
| |
| consumers with liver or
| ask a doctor
|
| kidney disease
|
For Cetirizine Hydrochloride Chewable Tablets, 10 mg
| adults and children 6
| one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A
|
| years and over
| 5 mg product may be appropriate for less severe symptoms.
|
| adults 65 years and
| ask a doctor
|
| over
| |
| children under 6 years of age
| ask a doctor
|
| consumers with liver
| ask a doctor
|
| or kidney disease
|
Other information
Inactive Ingredients
acesulfame potassium, colloidal silicon dioxide, D&C YELLOW # 10, FD&C RED # 40, FD&C YELLOW # 6, low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polacrilex resin, sodium starch glycolate, sucralose and tutti frutti flavor
Questions
Call 1-866-403-7592
Manufactured by:
Novel Laboratories, Inc.
Somerset, NJ 08873
Package Label.Principal Display Panel
For 5 mg Allergy:
NDC 40032-653-03
Children's
Cetirizine Hydrochloride Chewable Tablets
5 mg
ALLERGY
Antihistamine
Indoor & Outdoor Allergies
Tutti-frutti Flavor
6 yrs. & older
30 CHEWABLE TABLETS
Container Label
Container Carton
For 10 mg Allergy:
NDC 40032-652-31
Children's
Cetirizine Hydrochloride Chewable Tablets
10 mg
ALLERGY
Antihistamine
Indoor & Outdoor Allergies
Tutti-frutti Flavor
6 yrs. & older
Blister Label
Blister Carton
NDC 40032-652-30
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