FDA.reportPublic FDA data

Cetirizine Tablets 10 mg Drugs Facts

Manufacturer
Indoco Remedies Limited
Effective date
2024-10-07
Label type
Human OTC Drug Label
Version
6
Source
full-release
Hydrated at
2026-06-01 00:23:45

Label at a glance#

ProductCETIRIZINE HYDROCHLORIDE
Active ingredientCETIRIZINE HYDROCHLORIDE
Label structure7 sections

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 store between 20° to 25°C (68° to 77°F) do not use if foil inner seal is broken or missing FDA approved di...

Label contents#

Full prescribing information#

ACTIVE INGREDIENT(S)

OTC - ACTIVE INGREDIENT SECTION


Cetirizine HCl 10 mg



PURPOSE

OTC - PURPOSE SECTION

Antihistamine

USE(S)

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

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

Keep out of reach of children. 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 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


Other information

Spl Unclassified Section

  • store between 20° to 25°C (68° to 77°F)
  • do not use if foil inner seal is broken or missing
  • FDA approved dissolution test specifications differ from USP

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

Questions?

Spl Unclassified Section

Call at +1-855-642-2594

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Original Prescription Strength

NDC 14445-152-30

Cetirizine Hydrochloride Tablets
ALLERGY

Cetirizine HCl tablets
10 mg /antihistamine

Indoor & Outdoor Allergies

24 hour Relief of
• runny nose
• sneezing
• itchy, watery eyes
• itchy throat or nose
30 Tablets
10 mg each

Container Label:

 

container-label
container-label

Carton Label:

carton-labelcarton-label

    

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN6
1014678cetirizine hydrochloride 10 MG Oral TabletSCD6
1014678cetirizine HCl 10 MG Oral TabletSY6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CETIRIZINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14445-152-01CETIRIZINE HYDROCHLORIDE100 in 1 BOTTLETABLET, FILM COATED1006
14445-152-01CETIRIZINE HYDROCHLORIDE1 in 1 CARTONTABLET, FILM COATED16
14445-152-03CETIRIZINE HYDROCHLORIDE300 in 1 BOTTLETABLET, FILM COATED3006
14445-152-03CETIRIZINE HYDROCHLORIDE1 in 1 CARTONTABLET, FILM COATED16
14445-152-05CETIRIZINE HYDROCHLORIDE500 in 1 BOTTLETABLET, FILM COATED5006
14445-152-05CETIRIZINE HYDROCHLORIDE1 in 1 CARTONTABLET, FILM COATED16
14445-152-30CETIRIZINE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED306
14445-152-30CETIRIZINE HYDROCHLORIDE1 in 1 CARTONTABLET, FILM COATED16
14445-152-90CETIRIZINE HYDROCHLORIDE90 in 1 BOTTLETABLET, FILM COATED906
14445-152-90CETIRIZINE HYDROCHLORIDE1 in 1 CARTONTABLET, FILM COATED16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14445-152CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [INDOCO REMEDIES LIMITED ]6Current NDC, 10 package rows20241010_2942e093-5077-44d3-b080-8d945d03c55f.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
14445-15214445-152-30, 14445-152-90, 14445-152-01, 14445-152-03, 14445-152-05

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
NameUNIIKind
CETIRIZINE HYDROCHLORIDE64O047KTOAACTIB
ANHYDROUS LACTOSE3SY5LH9PMKIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
MAGNESIUM STEARATE70097M6I30IACT
HYPROMELLOSE 2910 (6 MPA.S)0WZ8WG20P6IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT

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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A218895-001CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2024-10-03

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A218895-001CETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2024-10-0384e616aacf4f…
2026-08-18 06:07:402026-07A218895-001CETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2024-10-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A218895-001CETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2024-10-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218895-001CETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2024-10-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A218895-001CETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2024-10-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218895-001CETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2024-10-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218895-001CETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2024-10-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218895-001CETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2024-10-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218895-001CETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2024-10-032680178bc6a6…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218895-001CETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2024-10-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A218895-001CETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2024-10-03d06236e962d9…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218895-001CETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2024-10-03a50c72e98297…

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 HYDROCHLORIDECETIRIZINE HYDROCHLORIDEIndoco Remedies Limited2942e093-5077-44d3-b080-8d945d03c55f2024-10-07WarningsExact identifier
ndc (package): 14445-152-05
ndc (package): 14445-152-30
ndc (package): 14445-152-01
ndc (package): 14445-152-03
ndc (package): 14445-152-90
ndc (product): 14445-152
ndc11 (package): 14445015203
ndc11 (package): 14445015290
ndc11 (package): 14445015230
ndc11 (package): 14445015205
ndc11 (package): 14445015201
spl id: c1a05a6d-3db7-446f-927b-787a062ad1ae
spl set id: 2942e093-5077-44d3-b080-8d945d03c55f

Reported adverse events (FAERS/openFDA)#

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