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:
CVS Pharmacy, Inc.
One CVS Drive,
Woonsocket, RI 02895
© 2023 CVS/pharmacy
CVS.com®
1-800-SHOP CVS

Made in India

Code: TS/DRUGS/19/1993

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (30 Tablets Container Label)

♥CVS

Health®

NDC 69842-237-09

Indoor & Outdoor
Allergies

Original Prescription Strength
Allergy Relief

CETIRIZINE
HYDROCHLORIDE
TABLETS USP 10 mg
Antihistamine

24 Hour
30 TABLETS

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (30 Tablets Container Label)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (30 Tablets Container Carton Label)

♥CVS Health®

Compare to the active

ingredient in Zyrtec® Tablets*

Indoor & Outdoor Allergies

NDC 69842-237-09

Original Prescription Strength
Allergy Relief

CETIRIZINE HYDROCHLORIDE
TABLETS USP 10 mg
Antihistamine

24 Hour

Relief of:

Sneezing
Runny nose
Itchy, watery eyes
Itchy throat or nose

Actual Size
30 TABLETS        Actual Bottle Size
                                 on Side Panel
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (30 Tablets Container Carton Label)

CETIRIZINE HYDROCHLORIDE (ALLERGY)
cetirizine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69842-237
Route of Administration	ORAL

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)

Product Characteristics
Color	WHITE (White to Off-white)	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	X;36
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69842-237-91	1 in 1 CARTON	07/26/2019	06/10/2023
1		30 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:69842-237-09	1 in 1 CARTON	07/26/2019
2		30 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:69842-237-17	1 in 1 CARTON	07/26/2019
3		45 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC:69842-237-54	1 in 1 CARTON	07/26/2019	01/11/2021
4		70 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC:69842-237-19	1 in 1 CARTON	07/26/2019
5		90 in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC:69842-237-23	1 in 1 CARTON	07/26/2019
6		120 in 1 BOTTLE; Type 0: Not a Combination Product
7	NDC:69842-237-45	2 in 1 CARTON	07/26/2019
7		120 in 1 BOTTLE; Type 0: Not a Combination Product
8	NDC:69842-237-39	365 in 1 BOTTLE; Type 0: Not a Combination Product	07/26/2019
9	NDC:69842-237-60	1 in 1 CARTON	07/26/2019	01/10/2022
9		5 in 1 BLISTER PACK; Type 0: Not a Combination Product
10	NDC:69842-237-57	1 in 1 CARTON	07/26/2019	01/08/2023
10		5 in 1 BLISTER PACK; Type 0: Not a Combination Product
11	NDC:69842-237-01	1 in 1 CARTON	07/26/2019
11		14 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA090760	07/26/2019

Labeler - CVS Pharmacy, Inc. (062312574)

Registrant - Aurohealth LLC (078728447)

Name	Address	ID/FEI	Business Operations
Establishment
Aurobindo Pharma Limited		918917642	ANALYSIS(69842-237) , MANUFACTURE(69842-237)