Cetirizine HCl

Manufacturer: Praxis, LLC
Effective date: 2023-01-01
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: legacy-cache
Hydrated at: 2026-08-01 20:37:08

Label at a glance#

ProductCetirizine HCl

Active ingredientCETIRIZINE HYDROCHLORIDE

Label structure9 sections

Indications and 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

Dosage and administration

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

Storage and handling

store at 20º-25ºC (68º-77ºF) avoid high humidity and excessive heat above 40ºC (104ºF) protect from light

Contacts and useful links#

PhoneLabel contact1-800-910-6874

Label contents#

Full prescribing information#

Active ingredient (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

Cetirizine HCl 10 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

liver or kidney disease. Your doctor should determine if you need a different dose.

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking tranquilizers or sedatives.

When using this product

OTC - WHEN USING SECTION

drowsiness may occur
alcohol, sedatives, and tranquilizers may increase drowsiness
avoid alcoholic drinks
be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

OTC - STOP USE SECTION

an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding:

OTC - PREGNANCY OR BREAST FEEDING SECTION

if breast-feeding: not recommended
if pregnant: ask a health professional before use

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

store at 20º-25ºC (68º-77ºF)
avoid high humidity and excessive heat above 40ºC (104ºF)
protect from light

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C yellow #6, gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol, purified water, sodium hydroxide, sorbitan, sorbitol

Questions?

OTC - QUESTIONS SECTION

call 1-800-910-6874

*All trademarks are property of their respective owners. This product is not affiliated with the makers/owners of Zyrtec ^®.

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

KEEP THIS CARD FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Dist. by Target Corp., Mpls., MN 55403

L0000276

R1019

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 11673-242-15

Compare to active ingredient in Zyrtec ^®*

allergy relief

cetirizine HCl capsules, 10 mg antihistamine

indoor and outdoor allergies

24 hour relief of:
• sneezing
• runny nose
• itchy, watery eyes
• itchy throat or nose

24HOUR RELIEF

ACTUAL SIZE

40SOFTGELS ^**

up & up_TM

40 SOFTGELS ^** ( ^**LIQUID-FILLED CAPSULES)
10 mg EACH

front

40's bottle Label front

back

40's bottle Label back

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

Cetirizine HCl
FD&C YELLOW NO. 6
GELATIN
GLYCERIN
MANNITOL
POLYETHYLENE GLYCOL, UNSPECIFIED
WATER
SODIUM HYDROXIDE
SORBITAN
SORBITOL
CETIRIZINE HYDROCHLORIDE
CETIRIZINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
59368-392	59368-392-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
FD&C YELLOW NO. 6	H77VEI93A8	IACT
GELATIN	2G86QN327L	IACT
GLYCERIN	PDC6A3C0OX	IACT
MANNITOL	3OWL53L36A	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
WATER	059QF0KO0R	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
SORBITAN	6O92ICV9RU	IACT
SORBITOL	506T60A25R	IACT
CETIRIZINE HYDROCHLORIDE	64O047KTOA	ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
36e9041d-9bc3-c4ee-e063-6394a90a1196			36e91451-619d-c4cb-e063-6394a90a728e	2023-01-01	Warnings	Exact identifier spl id: 36e9041d-9bc3-c4ee-e063-6394a90a1196 spl set id: 36e91451-619d-c4cb-e063-6394a90a728e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.