Cetirizine Hydrochloride Tablets

Manufacturer
Care One (Retail Business Services, LLC.)
Effective date
2026-11-04
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
daily-update
Hydrated at
2026-11-07 03:01:37

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

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
  • in rare cases, you may experience itching after stopping cetirizine. Consult your healthcare provider if this happens.

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 25oC (68o to 77oF)
  • avoid high humidity and excessive heat above 40oC (104o F)
  • protect from light

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Butylated hydroxytoluene, gelatin, glycerin, pharmaceutical ink*, polyethylene glycol 400, purified water, sodium hydroxide, sorbitan, sorbitol

*may contain this ingredient

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

SPL UNCLASSIFIED SECTION

Compare to the active ingredient in Zyrtec® Liquid Gels†

Allergy Relief

Cetirizine HCI CAPSULES,

10 mg Antihistamine

FOR ALLERGY RELIEF OF:

  • Sneezing
  • Runny Nose
  • Itchy, Watery eyes
  • Itchy Throat or Nose

SOFTGELS**

(**LIQUID-FILLED CAPSULES)

†This product is not manufactured or distributed by Kenvue Brands LLC, 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:

ADUSA DISTRIBUTION, LLC

SALISBURY, NC 28147

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Care One Cetirizine HCl 10 mg Softgel
Care One Cetirizine HCl 10 mg Softgel

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130341520001239GTIN-13: 0341520001239
EAN-13: 0341520001239
GTIN-12: 341520001239
UPC-A: 341520001239
GTIN storage (14 digits): 00341520001239
cetirizine-hcl-10-mg-softgel-cat-1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72476-06472476-064-25

Ingredients#

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

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

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22022-10-20full-release2026-05-31 23:51:06

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 45.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A213105-001CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE10MGCAPSULE / ORAL2020-09-21

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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-11-14 07:37:172026-10A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21d4dbc9d85df4…
2026-10-15 13:18:302026-09A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21c2088c7a36db…
2026-09-14 22:38:342026-08A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-2184e616aacf4f…
2026-08-18 06:07:402026-07A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-214b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-2187673890dc5c…
2021-03-12 10:30 UTC2021-03A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-213f0d92c62455…
2023-05-13 08:27 UTC2023-05A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21053a50430f4f…
2023-01-26 05:58 UTC2023-01A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21cb3db0bc1861…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e3d08c78-89a2-4185-8e6f-07fbdc01825404a6087e-d854-4e70-9d89-3971890a44a32022-10-20WarningsExact identifier
spl set id: 04a6087e-d854-4e70-9d89-3971890a44a3

Reported adverse events (FAERS/openFDA)#

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