Other
Drug Facts
Cetirizine Hydrochloride (allergy) Tablet
FDA Label NDC 58602-445
19 label sections · Submitted to the FDA by Aurohealth Llc · 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 58602-445). 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 tablet), purpose, uses, warnings, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, 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 Tablet)
For 5 mg:
Cetirizine hydrochloride USP 5 mg
For 10 mg:
Cetirizine hydrochloride 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.
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.
- in rare cases, you may experience itching after stopping cetirizine. Consult your healthcare provider if this happens.
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
For 5 mg:
| adults and children 6 years and over | 1 tablet (5 mg) or 2 tablets (10 mg) once daily depending upon severity of symptoms; do not take more than 2 tablets (10 mg) in 24 hours. |
| adults 65 years and over | 1 tablet (5 mg) once daily; do not take more than 1 tablet (5 mg) in 24 hours. |
| children under 6 years of age | ask a doctor |
| consumers with liver or kidney disease | ask a doctor |
For 10 mg:
| 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)
- TAMPER EVIDENT: DO NOT USE IF FOIL INNER SEAL IMPRINTED WITH "SEALED FOR YOUR PROTECTION" IS BROKEN OR MISSING.
Inactive Ingredients
colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide.
Questions?
call 1-855-274-4122
Distributed by:
AUROHEALTH LLC
279 Princeton-Hightstown,
East Windsor, NJ 08520
Made in India
Package Label-Principal Display Panel - 5 Mg (30'S Tablet Container Carton Label)
AUROHEALTH
NDC 58602-444-09
*Compare to the active
ingredient of Zyrtec®
Original Prescription Strength
Allergy Relief
Cetirizine Hydrochloride
Tablets USP 5 mg
Antihistamine
Indoor & Outdoor Allergies
5 mg Strength Tablets
24 Hour relief of
Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose
30 Tablets Package Label-principal Display Panel (5 mg (30's Tablet Container Carton Label))
5 mg each 
Package Label-Principal Display Panel -5 Mg (10 X 10 Blister Carton Label)
AUROHEALTH
NDC 58602-444-21
*Compare to the active
ingredient of Zyrtec®
Allergy Relief
Cetirizine Hydrochloride Tablets USP 5 mg
Antihistamine
Original Prescription Strength
Indoor & Outdoor Allergies
5 mg Strength Tablets
24 Hour relief of
Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose
100 (10 x 10) Package Label-principal Display Panel -5 mg (10 X 10 Blister Carton Label) (Cetirizine Fig2)
Unit-dose Tablets
5 mg each 
Package Label-Principal Display Panel - 10 Mg (30'S Tablet Container Carton Label)
AUROHEALTH
NDC 58602-445-09
*Compare to the active
ingredient of Zyrtec®
Allergy Relief
Cetirizine Hydrochloride Tablets USP 10 mg
Antihistamine
Original Prescription Strength
Indoor & Outdoor Allergies
10 mg Strength Tablets
24 Hour relief of
Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose
30 Tablets Package Label-principal Display Panel (10 mg (30's Tablet Container Carton Label))
10 mg each 
Package Label-Principal Display Panel - 10 Mg (10 X 10 Blister Carton Label)
AUROHEALTH
NDC 58602-445-21
*Compare to the active
ingredient of Zyrtec®
Allergy Relief
Cetirizine Hydrochloride Tablets USP 10 mg
Antihistamine
Original Prescription Strength
Indoor & Outdoor Allergies
10 mg Strength Tablets
24 Hour relief of
Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose
100 (10x10)Tablets Package Label-principal Display Panel (10 mg (10 x 10 Blister Carton Label))
10 mg each 
* Please review the disclaimer below.
