Other
Cetirizine HCl Capsules 10 mg (Allergy)
Drug Facts
Cetirizine Hydrochloride (allergy) Capsule
FDA Label NDC 58602-863
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aurohealth Llc for the product Cetirizine Hydrochloride (allergy) (NDC 58602-863). 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 other, active ingredient (in each capsule), purpose, uses, warnings, otc - ask doctor, otc - ask doctor/pharmacist, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Capsule)
Cetirizine HCl USP 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 reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.
Otc - Ask Doctor
Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
Otc - Ask Doctor/Pharmacist
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 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. (1-800-222-1222)
Directions
| adults and children 6 years and over | one 10 mg capsule once daily; do not take more than one 10 mg capsule 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 at 20°-25°C (68°-77°F)
- avoid high humidity and excessive heat above 40°C (104°F)
- protect from light
- do not use if seal imprinted with SEALED for YOUR PROTECTION under the bottle cap is broken or missing.
Inactive Ingredients
black iron oxide, gelatin, glycerin, hypromellose, polyethylene glycol, propylene glycol, purified water, sodium hydroxide, sorbitol sorbitan solution
Questions Or Comments?
call 1-855-274-4122 (Monday - Friday 8:30 AM to 5:00 PM EST)
Distributed by:
AUROHEALTH LLC
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Made in India
Code: TS/DRUGS/16/2014
Package Label-Principal Display Panel - 10 Mg (40'S Capsule Container Label)
PrimaryHealth NDC 58602-863-12 Package Label-principal Display Panel (10 mg (12's Capsule Container Label))
ALLERGY
Original
Prescription Strength
Cetirizine HCl Capsules
10 mg
Antihistamine
INDOOR + OUTDOOR ALLERGIES
40 LIQUID GELS*
* LIQUID-FILLED CAPSULES 
Package Label-Principal Display Panel -10 Mg (40'S Capsule Container Carton Label)
NDC 58602-863-12
PrimaryHealth
COMPARE TO Zyrtec®
active ingredient*
Original Prescription Strength
ALLERGY
Cetirizine HCl Capsules
10 mg
Antihistamine
INDOOR +OUTDOOR ALLERGIES
24 HOUR
RELIEF OF
- Sneezing
- Runny Nose
- Itchy, Watery Eyes
- Itchy Throat or Nose
CZ10 Package Label-principal Display Panel -10 mg (12's Capsule Container Carton Label) (Cetirizine Allergy Fig2)
(Actual size)
40 LIQUID GELS*
* LIQUID-FILLED CAPSULES 
* Please review the disclaimer below.
