Active Ingredient In Each Chewable Tablet
For 5 mg:
Cetirizine hydrochloride 5 mg
For 10 mg:
Cetirizine hydrochloride 10 mg
The following Structured Product Label (SPL) was submitted to the FDA by Novel Laboratories, Inc. for the product Cetirizine Hydrochloride (NDC 40032-652). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding 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, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
For 5 mg:
Cetirizine hydrochloride 5 mg
For 10 mg:
Cetirizine hydrochloride 10 mg
Antihistamine
Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
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.
liver or kidney disease. Your doctor should determine if you need a different dose.
if you are taking tranquilizers or sedatives.
an allergic reaction to this product occurs. Seek medical help right away.
In case of overdose, get medical help or contact a Poison Control Center right away at (1-800-222-1222).
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
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
Call 1-866-403-7592
Manufactured by:
Novel Laboratories, Inc.
Somerset, NJ 08873
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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