FDA.reportPublic FDA data

Allergy Relief Cetirizine Hydrochloride Tablets USP, 5 mg and 10 mg

Manufacturer
MARKSANS PHARMA LIMITED
Effective date
2026-07-10
Label type
Human OTC Drug Label
Version
14
Source
daily-update
Hydrated at
2026-07-18 05:10:19

Label at a glance#

ProductCetirizine Hydrochloride Tablets, 5 mg
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

For 5 mg: adults and children 6 years and over 1 tablet (5 mg) or 2 tablets (10 mg) once daily depending upon severity of symptoms; do not take more than 2 tablets (10 mg) in 24 hours adults 65 years and ove r 1 tablet (5 mg) once daily; do not take more than 1 tablet (5 mg) in 24 hours. children under 6 years of age ask a doctor  consumers with liver or kidney disease ask a doctor     For 10 mg: adults and childr...

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

For 5 mg:

Cetirizine HCl USP 5 mg


For 10 mg:

Cetirizine HCl USP 10 mg


For 10 mg (Oval Shape):

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

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.

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

For 5 mg:


adults and children 6 years and over1 tablet (5 mg) or 2 tablets (10 mg) once daily depending upon severity of symptoms; do not take more than 2 tablets (10 mg) in 24 hours
adults 65 years and over1 tablet (5 mg) once daily; do not take more than 1 tablet (5 mg) in 24 hours.
children under 6 years of ageask a doctor 
consumers with liver or kidney diseaseask a doctor  

 

For 10 mg:


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

SPL UNCLASSIFIED SECTION

•store between 20° to 25°C (68° to 77°F)
•do not use if foil seal under cap is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, titanium dioxide


Questions or comments? Call 1-877-376-4271
(weekdays 9 AM to 5 PM)

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 25000-219-03
Cetirizine Hydrochloride Tablets USP, 5 mg
30s count bottle label

  

cetirizine-hcl-5-mg-30ct-bottle
cetirizine-hcl-5-mg-30ct-bottle

NDC 25000-219-03
Cetirizine Hydrochloride Tablets USP, 5 mg
30s count carton label

cetirizine-hcl-5-mg-30ct-ifccetirizine-hcl-5-mg-30ct-ifc



NDC 25000-219-08
Cetirizine Hydrochloride Tablets USP, 5 mg
100s count bottle label

 

cetirizine-hcl-5-mg-100ct-bottle
cetirizine-hcl-5-mg-100ct-bottle


NDC 25000-219-08
Cetirizine Hydrochloride Tablets USP, 5 mg
100s count carton label

cetirizine-hcl-5-mg-100ct-ifccetirizine-hcl-5-mg-100ct-ifc

 


NDC 25000-219-14 
Cetirizine Hydrochloride Tablets USP, 5 mg
1000s count bottle label  

cetirizine-hcl-5-mg-1000ct-bottlecetirizine-hcl-5-mg-1000ct-bottle

 


NDC 25000-220-03
Cetirizine Hydrochloride Tablets USP, 10 mg

30s count bottle label

 

cetirizine-hcl-10-mg-30s-bottle
cetirizine-hcl-10-mg-30s-bottle


NDC 25000-220-03
Cetirizine Hydrochloride Tablets USP, 10 mg

30s count carton label

cetirizine-hcl-10-mg-30s-ifccetirizine-hcl-10-mg-30s-ifc

 


NDC 25000-220-08
Cetirizine Hydrochloride Tablets USP, 10 mg
100s count bottle label

 

cetirizine-hcl-10-mg-100s-bottle
cetirizine-hcl-10-mg-100s-bottle


NDC 25000-220-08
Cetirizine Hydrochloride Tablets USP, 10 mg

100s count carton label

cetirizine-hcl-10-mg-100ct-ifccetirizine-hcl-10-mg-100ct-ifc

 


NDC 25000-220-14
Cetirizine Hydrochloride Tablets USP, 10 mg
1000s count bottle label

cetirizine-hcl-10-mg-1000s-labelcetirizine-hcl-10-mg-1000s-label

 


NDC 25000-220-78
Cetirizine Hydrochloride Tablets USP, 10 mg

7s count carton label

cetirizine-hcl-10-mg-7s-ifccetirizine-hcl-10-mg-7s-ifc

 


NDC 25000-220-81
Cetirizine Hydrochloride Tablets USP, 10 mg

14s count carton label

cetirizine-hcl-10-mg-14s-ifccetirizine-hcl-10-mg-14s-ifc

 


NDC 25000-160-81
Cetirizine Hydrochloride Tablets USP, 10 mg (Oval Shape)

14s count carton label

cetirizine-hcl-10-mg-oval-14s-carton-labelcetirizine-hcl-10-mg-oval-14s-carton-label

 


NDC 25000-160-03
Cetirizine Hydrochloride Tablets USP, 10 mg (Oval Shape)

30s count carton label

cetirizine-hcl-10-mg-oval-30s-cartoncetirizine-hcl-10-mg-oval-30s-carton

 


NDC 25000-160-03 (Oval Shape)
Cetirizine Hydrochloride Tablets USP, 10 mg

30s count bottle label

cetirizine-hcl-10-mg-oval-30s-labelcetirizine-hcl-10-mg-oval-30s-label

 


NDC 25000-160-14
Cetirizine Hydrochloride Tablets USP, 10 mg (Oval Shape)

1000s count bottle label

cetirizine-hcl-10-mg-oval-1000s-labelcetirizine-hcl-10-mg-oval-1000s-label


Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130325000160036GTIN-13: 0325000160036
EAN-13: 0325000160036
GTIN-12: 325000160036
UPC-A: 325000160036
GTIN storage (14 digits): 00325000160036		cetirizine-hcl-10-mg-oval-30s-carton.jpg
BarcodeEAN-130325000160142GTIN-13: 0325000160142
EAN-13: 0325000160142
GTIN-12: 325000160142
UPC-A: 325000160142
GTIN storage (14 digits): 00325000160142		cetirizine-hcl-10-mg-oval-1000s-label.jpg
BarcodeEAN-130325000160814GTIN-13: 0325000160814
EAN-13: 0325000160814
GTIN-12: 325000160814
UPC-A: 325000160814
GTIN storage (14 digits): 00325000160814		cetirizine-hcl-10-mg-oval-14s-carton-label.jpg
BarcodeEAN-130325000219031GTIN-13: 0325000219031
EAN-13: 0325000219031
GTIN-12: 325000219031
UPC-A: 325000219031
GTIN storage (14 digits): 00325000219031		cetirizine-hcl-5-mg-30ct-ifc.jpg
BarcodeEAN-130325000219086GTIN-13: 0325000219086
EAN-13: 0325000219086
GTIN-12: 325000219086
UPC-A: 325000219086
GTIN storage (14 digits): 00325000219086		cetirizine-hcl-5-mg-100ct-ifc.jpg
BarcodeEAN-130325000219147GTIN-13: 0325000219147
EAN-13: 0325000219147
GTIN-12: 325000219147
UPC-A: 325000219147
GTIN storage (14 digits): 00325000219147		cetirizine-hcl-5-mg-1000ct-bottle.jpg
BarcodeEAN-130325000220037GTIN-13: 0325000220037
EAN-13: 0325000220037
GTIN-12: 325000220037
UPC-A: 325000220037
GTIN storage (14 digits): 00325000220037		cetirizine-hcl-10-mg-30s-ifc.jpg
BarcodeEAN-130325000220082GTIN-13: 0325000220082
EAN-13: 0325000220082
GTIN-12: 325000220082
UPC-A: 325000220082
GTIN storage (14 digits): 00325000220082		cetirizine-hcl-10-mg-100ct-ifc.jpg
BarcodeEAN-130325000220143GTIN-13: 0325000220143
EAN-13: 0325000220143
GTIN-12: 325000220143
UPC-A: 325000220143
GTIN storage (14 digits): 00325000220143		cetirizine-hcl-10-mg-1000s-label.jpg
BarcodeEAN-130325000220785GTIN-13: 0325000220785
EAN-13: 0325000220785
GTIN-12: 325000220785
UPC-A: 325000220785
GTIN storage (14 digits): 00325000220785		cetirizine-hcl-10-mg-7s-ifc.jpg
BarcodeEAN-130325000220815GTIN-13: 0325000220815
EAN-13: 0325000220815
GTIN-12: 325000220815
UPC-A: 325000220815
GTIN storage (14 digits): 00325000220815		cetirizine-hcl-10-mg-14s-ifc.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402

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
25000-16025000-160-81, 25000-160-03, 25000-160-14
25000-21925000-219-03, 25000-219-08, 25000-219-14
25000-22025000-220-03, 25000-220-08, 25000-220-14, 25000-220-78, 25000-220-81

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETIRIZINE HYDROCHLORIDE64O047KTOAACTIB
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
STARCH, CORNO8232NY3SJIACT
POVIDONE K30U725QWY32XIACT
MAGNESIUM STEARATE70097M6I30IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
CETIRIZINE HYDROCHLORIDE64O047KTOAACTIB
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
STARCH, CORNO8232NY3SJIACT
POVIDONE K30U725QWY32XIACT
MAGNESIUM STEARATE70097M6I30IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
CETIRIZINE HYDROCHLORIDE64O047KTOAACTIB
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
STARCH, CORNO8232NY3SJIACT
POVIDONE K30U725QWY32XIACT
MAGNESIUM STEARATE70097M6I30IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
132025-07-31full-release2026-06-01 01:09:02

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
A078933-001CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE5MGTABLET / ORAL2010-06-15
A078933-002CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2010-06-15
A078933-003CETIRIZINE HYDROCHLORIDE HIVESCETIRIZINE HYDROCHLORIDE5MGTABLET / ORAL2010-06-15
A078933-004CETIRIZINE HYDROCHLORIDE HIVESCETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2010-06-15

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 22:38:342026-08A078933-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2010-06-1584e616aacf4f…
2026-09-14 22:38:342026-08A078933-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2010-06-1584e616aacf4f…
2026-09-14 22:38:342026-08A078933-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2010-06-1584e616aacf4f…
2026-09-14 22:38:342026-08A078933-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2010-06-1584e616aacf4f…
2026-08-18 06:07:402026-07A078933-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2010-06-15caaa826d4ba7…
2026-08-18 06:07:402026-07A078933-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2010-06-15caaa826d4ba7…
2026-08-18 06:07:402026-07A078933-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2010-06-15caaa826d4ba7…
2026-08-18 06:07:402026-07A078933-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2010-06-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078933-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2010-06-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078933-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2010-06-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078933-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2010-06-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078933-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2010-06-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078933-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2010-06-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078933-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2010-06-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078933-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2010-06-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078933-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2010-06-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A078933-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2010-06-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078933-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2010-06-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078933-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2010-06-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078933-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2010-06-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078933-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2010-06-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078933-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2010-06-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078933-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2010-06-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078933-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2010-06-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078933-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2010-06-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078933-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2010-06-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078933-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2010-06-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078933-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2010-06-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078933-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2010-06-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078933-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2010-06-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078933-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2010-06-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078933-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2010-06-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078933-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2010-06-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078933-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2010-06-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078933-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2010-06-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078933-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2010-06-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078933-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2010-06-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078933-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2010-06-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078933-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2010-06-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078933-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2010-06-155bbf6a4d5a75…

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
Cetirizine Hydrochloride Tablets, 10 mg (Oval Shape)CETIRIZINE HYDROCHLORIDEMARKSANS PHARMA LIMITED652b0c65-a3f2-4454-9cf2-51a3389282cc2026-07-10WarningsExact identifier
ndc (package): 25000-219-14
ndc (package): 25000-220-81
ndc (package): 25000-219-08
ndc (package): 25000-220-78
ndc (package): 25000-220-03
ndc (package): 25000-219-03
ndc (package): 25000-160-14
ndc (package): 25000-220-14
ndc (package): 25000-220-08
ndc (package): 25000-160-03
ndc (package): 25000-160-81
ndc (product): 25000-220
ndc (product): 25000-219
ndc (product): 25000-160
ndc11 (package): 25000016081
ndc11 (package): 25000022014
ndc11 (package): 25000022078
ndc11 (package): 25000021914
ndc11 (package): 25000016014
ndc11 (package): 25000022008
ndc11 (package): 25000022003
ndc11 (package): 25000021908
ndc11 (package): 25000016003
ndc11 (package): 25000021903
ndc11 (package): 25000022081
spl id: 172d56b9-ba90-4e1b-934a-f75307564ea3
spl set id: 652b0c65-a3f2-4454-9cf2-51a3389282cc

Reported adverse events (FAERS/openFDA)#

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