FDA.reportPublic FDA data

Cetirizine HCl 10 mg film coated tablet

Manufacturer
Medline Industries, LP
Effective date
2026-09-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-09-18 01:00:55

Label at a glance#

ProductMedline Industries
Active ingredientCETIRIZINE HYDROCHLORIDE
Label structure11 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 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

Storage and handling

store between 20-25ºC (68-77ºF) do not use if printed foil under cap is broken or missing

Label contents#

Full prescribing information#

Active ingredient

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 if you have ever had any 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
  • 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. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 6 years and overone 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 overask a doctor
children under 6 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor

Other information

STORAGE AND HANDLING SECTION

  • store between 20-25ºC (68-77ºF)
  • do not use if printed foil under cap is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, FD&C blue no.1 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, polydextrose, polyethylene glycol, povidone, titanium dioxide, triacetin

Questions or comments?

OTC - QUESTIONS SECTION

call 1-800-MEDLINE (633-5463)

Monday - Friday, 7 a.m. to 7 p.m. CST

Manufacturing information

SPL UNCLASSIFIED SECTION

**This product is not manufactured or

distributed by Kenvue, Inc., ownder of

the registered trademark Zyrtec®

www.medline.com ©2026 Medline

Manufactured for: Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

1-800 MEDLINE

OTHER SAFETY INFORMATION

IMPORTANT: READ ALL PRODUCT INFORMATION

BEFORE USING. KEEP THIS PACKAGE FOR

IMPORTANT INFORMATION

DO NOT USE IF PRINTED FOIL

UNDER CAP IS BROKEN OR MISSING

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Box labelBox label

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53329-03653329-036-33, 53329-036-05, 53329-036-38, 53329-036-09

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETIRIZINE HYDROCHLORIDE64O047KTOAACTIB
STARCH, CORNO8232NY3SJIACT
FD&C BLUE NO. 1 ALUMINUM LAKEJ9EQA3S2JMIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT
POLYDEXTROSEVH2XOU12IEIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONEFZ989GH94EIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIACETINXHX3C3X673IACT

Source Document#

Source XML

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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078336-001CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE5MGTABLET / ORAL2007-12-27
A078336-002CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2007-12-27
A078336-003CETIRIZINE HYDROCHLORIDE HIVESCETIRIZINE HYDROCHLORIDE5MGTABLET / ORAL2007-12-27
A078336-004CETIRIZINE HYDROCHLORIDE HIVESCETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2007-12-27

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 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A078336-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-2784e616aacf4f…
2026-09-14 22:38:342026-08A078336-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-2784e616aacf4f…
2026-09-14 22:38:342026-08A078336-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-2784e616aacf4f…
2026-09-14 22:38:342026-08A078336-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-2784e616aacf4f…
2026-08-18 06:07:402026-07A078336-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-27caaa826d4ba7…
2026-08-18 06:07:402026-07A078336-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-27caaa826d4ba7…
2026-08-18 06:07:402026-07A078336-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-27caaa826d4ba7…
2026-08-18 06:07:402026-07A078336-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078336-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078336-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078336-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078336-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078336-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078336-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078336-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078336-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A078336-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078336-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078336-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078336-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078336-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078336-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078336-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078336-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078336-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078336-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078336-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078336-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078336-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078336-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078336-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078336-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078336-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078336-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078336-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078336-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078336-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078336-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078336-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078336-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-275bbf6a4d5a75…

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 14 · 267 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy ReliefCETIRIZINE HYDROCHLORIDELIDL US LLCe5fd935d-5b60-7270-e053-2995a90a71412026-09-09WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
all day allergyCETIRIZINE HYDROCHLORIDERite Aid Corporationbcbb9f5a-10b6-4a5e-a237-d29693d781032026-09-04WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDEBAJAJ MEDICAL, LLC36b24a3c-6284-5a6d-e063-6394a90a77432026-08-26WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDEBAJAJ MEDICAL, LLC36b6d0e4-8da5-9df5-e063-6294a90af3262026-08-26WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEAurohealth LLC17e93c22-1ff7-4af9-bd5a-448836aec65f2026-08-25WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Childrens Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEAurohealth LLCcd895177-3c25-4a1b-81a0-b85f4877787a2026-08-25WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEStrides Pharma, Inc.29c433eb-6cf4-4bcf-8b2a-0398fb4cdcba2026-08-24WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Zyrtec Allergy Cetirizine HClCETIRIZINE HYDROCHLORIDEJones Healthcare Group - Packaging Services, Inc59cf7672-fdde-ddbd-e063-6394a90a223b2026-08-24WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEBetter Living Brands, LLCf7e16d96-4f23-cbca-e053-6394a90aef4e2026-08-24WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
GOOD REMEDIES All Day Allergy ReliefCETIRIZINE HYDROCHLORIDEStrive Pharmaceuticals Inc.44410d76-5940-4611-be45-579e2db8a65d2026-08-24WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.4913192a-7364-3f19-e054-00144ff8d46c2026-08-20WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Zyrtec Allergy Cetirizine HClCETIRIZINE HYDROCHLORIDEJones Healthcare Group - Packaging Services, Inc59cef432-41ac-768c-e063-6294a90a38fa2026-08-19WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
allergy reliefCETIRIZINE HYDROCHLORIDEWalgreen Company678dcc09-55da-4d9d-a39a-c450c61c387b2026-08-18WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
AMAZON BASICS ALL DAY ALLERGY RELIEFCETIRIZINE HYDROCHLORIDEAmazon.com Services LLC52163488-0b56-529d-e063-6294a90afc622026-08-17WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
QUZYTTIRCETIRIZINE HYDROCHLORIDEESTEVE PHARMACEUTICALS, S.A.573770f6-b76e-f6ba-e063-6294a90aa54d2026-08-13Warnings, Adverse reactionsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDELIDL US LLCbcbbcb24-2a58-917a-e053-2a95a90af9a92026-08-07WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
equate allergy reliefCETIRIZINE HYDROCHLORIDEWal-Mart Stores Incb33eb97f-5ac3-4eb7-b23a-cf550ce462872026-08-05WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEAurohealth LLC3cf969e6-6bc9-4dae-ab6a-b24c0fc46b252026-08-03WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride (Hives Relief)CETIRIZINE HYDROCHLORIDEAurohealth LLC2b9ac0cd-9dd1-4f78-a16d-9d40f5091c0a2026-08-03WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDECardinal Health 107, LLC0b0190c7-acfd-4140-bcaf-9fe835ebaf492026-07-30WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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