Cetirizine Hydrochloride Tablets

Manufacturer: WALMART INC. (see also Equate)
Effective date: 2026-06-18
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: monthly-update
Hydrated at: 2026-07-17 21:34:44

Label at a glance#

ProductAllergy Relief

Active ingredientCETIRIZINE HYDROCHLORIDE

Label structure16 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 to 25 o C (68 o to 77 o F) avoid high humidity and excessive heat above 40 o C (104 o F) protect from light

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-888-287-1915

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

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
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

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 (1-800-222-1222) 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 to 25^oC (68^o to 77^o F)
avoid high humidity and excessive heat above 40^oC (104^o F)
protect from light

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Butylated hydroxytolene, gelatin, glycerin, pharmaceutical ink*, polyethylene glycol 400, purified water, sodium hydroxide, Sorbitan, Sorbitol

*may contain this ingredient

Questions or comments?

OTC - QUESTIONS SECTION

1-888-287-1915

Principal Display Panel

SPL UNCLASSIFIED SECTION

Compare to ZYRTEC® active ingredient*

Allergy Relief

Cetirizine HCI

Capsules, 10 mg

Antihistamine

Indoor & Outdoor Allergies

24 Hour Relief of:

Sneezing
Runny nose
Itchy, watery eyes
Itchy throat or nose

24 HOUR

SOFTGELS**

**Liquid-filled capsules

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Zyrtec®.

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY: Walmart Inc.,

Bentonville, AR 72716

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0194346479092	GTIN-13: 0194346479092 EAN-13: 0194346479092 GTIN-12: 194346479092 UPC-A: 194346479092 GTIN storage (14 digits): 00194346479092	cetirizine-hcl-10-mg-softgel-cat-1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35be	Product name	1	20200304
a255659f-db40-429d-8c07-5f173f330d9c	Product name	1	20190402

Products#

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

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

Allergy Relief
Cetirizine HCl
CETIRIZINE HYDROCHLORIDE
CETIRIZINE
GELATIN
GLYCERIN
POLYETHYLENE GLYCOL 400
WATER
SODIUM HYDROXIDE
SORBITAN
SORBITOL
BUTYLATED HYDROXYTOLUENE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
79903-347	79903-347-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CETIRIZINE HYDROCHLORIDE	64O047KTOA	ACTIB
GELATIN	2G86QN327L	IACT
GLYCERIN	PDC6A3C0OX	IACT
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
WATER	059QF0KO0R	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
SORBITAN	6O92ICV9RU	IACT
SORBITOL	506T60A25R	IACT
BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
2	2025-04-21	full-release	2026-06-01 00:59:28

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	CAPSULE / ORAL			2020-09-21

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`a50c72e98297…`

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
Allergy Relief	CETIRIZINE HCL	WALMART INC. (see also Equate)	967be504-85b1-4e9b-9b08-2b27a43fa0aa	2026-06-18	Warnings	Exact identifier ndc (package): 79903-347-25 ndc (product): 79903-347 ndc11 (package): 79903034725 spl id: f14d4109-2aa6-4709-a64e-efb3ac5ffe7e spl set id: 967be504-85b1-4e9b-9b08-2b27a43fa0aa

Reported adverse events (FAERS/openFDA)#

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