CETIRIZINE HYDROCHLORIDE (ALLERGY)- cetirizine hydrochloride tablet

SPL UNCLASSIFIED SECTION

Drug Facts
Active ingredient (in each tablet)

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.
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 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 SEAL OVER BOTTLE OPENING 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:
Innovus Pharmaceuticals, Inc.
Reno, NV 89511
www.crclehealth.com

Made in India
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (365's Tablet Container Label)
*Compare to the
active ingredient
of Zyrtec®

Crcle™

NDC: 57483-190-14

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
365 TABLETS 10 mg each

INGREDIENTS AND APPEARANCE

CETIRIZINE HYDROCHLORIDE (ALLERGY)
cetirizine hydrochloride tablet

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)	CETIRIZINE HYDROCHLORIDE	10 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 57483-190-14	365 in 1 BOTTLE; Type 0: Not a Combination Product	04/28/2025

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA090760	04/28/2025

Labeler - INNOVUS PHARMACEUTICALS, INC. (962507187)

Registrant - Aurohealth LLC (078728447)

Name	Address	ID/FEI	Business Operations
Establishment
APL HEALTHCARE LIMITED		650844777	ANALYSIS(57483-190) , MANUFACTURE(57483-190)

Name	Address	ID/FEI	Business Operations
Establishment
Aurobindo Pharma Limited		918917642	ANALYSIS(57483-190) , MANUFACTURE(57483-190)

Cetirizine Hydrochloride (Allergy) by