FDA.reportPublic FDA data

Children's Cetirizine Hydrochloride Oral Solution

Manufacturer
Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc. | Mission Pharmacal Company
Effective date
2026-09-25
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
daily-update
Hydrated at
2026-09-29 01:04:14

Label at a glance#

ProductChildrens Cetirizine Hydrochloride
Active ingredientCETIRIZINE HYDROCHLORIDE
Label structure12 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

• use only with enclosed dosing cup • find right dose on chart below • mL = milliliter adults and children 6 years and over 5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours. adults 65 years and older 5 mL once daily; do not take more than 5 mL in 24 hours. children 2 to under 6 years of age 2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL...

Storage and handling

each 5mL contains: sodium 4 mg do not use if carton is opened or if imprinted safety seal is broken or missing see bottom panel for lot number and expiration date store between 20° to 25°C (68° to 77°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Cetirizine HCl 5 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

OTC - DO NOT USE 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.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are 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.

OTC - STOP USE SECTION

Stop use and ask a doctor if 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.

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

• use only with enclosed dosing cup
• find right dose on chart below
• mL = milliliter

adults and children 6 years and over5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours.
adults 65 years and older5 mL once daily; do not take more than 5 mL in 24 hours.
children 2 to under 6 years of age2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every 12 hours. Do not give more than 5 mL in 24 hours.
children under 2 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each 5mL contains: sodium 4 mg
  • do not use if carton is opened or if imprinted safety seal is broken or missing
  • see bottom panel for lot number and expiration date
  • store between 20° to 25°C (68° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

artificial grape flavor, glacial acetic acid, glycerin, propylene glycol, purified water, sodium acetate anhydrous, sodium benzoate, sucralose

Questions?

OTC - QUESTIONS SECTION

Call 1-866-923-4914

SPL UNCLASSIFIED SECTION

Distributed by:
Ohm Laboratories Inc.
New Brunswick, NJ 08901

120 mL Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CartonCarton

4 FL OZ (120 mL) Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 51672-2147-8

CetirizineHydrochloride Oral Solution 1 mg/mL ALLERGY

Grape Flavor

4 FL OZ (120 mL)

CartonCarton

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130351672214784GTIN-13: 0351672214784
EAN-13: 0351672214784
GTIN-12: 351672214784
UPC-A: 351672214784
GTIN storage (14 digits): 00351672214784		Ceterizine Carton.jpg, Cetirizine_GRSF_Carton_4oz_under950KB.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51672-2147-12026-01-28C16284748780-13b156c62-25a7-fb37-e063-e6dba90a4e07Children's Cetirizine Hydrochloride Oral Solution Sugar Free -Paraben Free Grape
51672-2147-12026-01-28C16284748780-13b156c62-25a7-fb37-e063-e6dba90a4e07Children's Cetirizine Hydrochloride Oral Solution Sugar Free -Paraben Free Grape
51672-2147-12026-01-28C16284748780-13b156c62-25a7-fb37-e063-e6dba90a4e07Children's Cetirizine Hydrochloride Oral Solution Sugar Free -Paraben Free Grape
51672-2147-82026-01-28C16284748780-13b156c62-25a7-fb37-e063-e6dba90a4e07Children's Cetirizine Hydrochloride Oral Solution Sugar Free -Paraben Free Grape
51672-2147-82026-01-28C16284748780-13b156c62-25a7-fb37-e063-e6dba90a4e07Children's Cetirizine Hydrochloride Oral Solution Sugar Free -Paraben Free Grape
51672-2147-82026-01-28C16284748780-13b156c62-25a7-fb37-e063-e6dba90a4e07Children's Cetirizine Hydrochloride Oral Solution Sugar Free -Paraben Free Grape
51672-2147-12025-07-29C16284748780-13b156c62-25a7-fb37-e063-e6dba90a4e07Children's Cetirizine Hydrochloride Oral Solution Sugar Free -Paraben Free Grape
51672-2147-12025-07-29C16284748780-13b156c62-25a7-fb37-e063-e6dba90a4e07Children's Cetirizine Hydrochloride Oral Solution Sugar Free -Paraben Free Grape
51672-2147-12025-07-29C16284748780-13b156c62-25a7-fb37-e063-e6dba90a4e07Children's Cetirizine Hydrochloride Oral Solution Sugar Free -Paraben Free Grape
51672-2147-82025-07-29C16284748780-13b156c62-25a7-fb37-e063-e6dba90a4e07Children's Cetirizine Hydrochloride Oral Solution Sugar Free -Paraben Free Grape
51672-2147-82025-07-29C16284748780-13b156c62-25a7-fb37-e063-e6dba90a4e07Children's Cetirizine Hydrochloride Oral Solution Sugar Free -Paraben Free Grape
51672-2147-82025-07-29C16284748780-13b156c62-25a7-fb37-e063-e6dba90a4e07Children's Cetirizine Hydrochloride Oral Solution Sugar Free -Paraben Free Grape

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
51672-214751672-2147-8, 51672-2147-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETIRIZINE HYDROCHLORIDE64O047KTOAACTIB
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM ACETATE ANHYDROUSNVG71ZZ7P0IACT
SUCRALOSE96K6UQ3ZD4IACT
SODIUM BENZOATEOJ245FE5EUIACT
ACETIC ACIDQ40Q9N063PIACT
GLYCERINPDC6A3C0OXIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32026-06-07daily-update2026-06-16 05:10:20
22025-07-03full-release2026-06-01 01:35:23

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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEFCETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2008-04-22
A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2008-04-22

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 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-2284e616aacf4f…
2026-09-14 22:38:342026-08A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-2284e616aacf4f…
2026-08-18 06:07:402026-07A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-22caaa826d4ba7…
2026-08-18 06:07:402026-07A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-228072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSYRUP / ORAL2008-04-225c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2008-04-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSYRUP / ORAL2008-04-225d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2008-04-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSYRUP / ORAL2008-04-224b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2008-04-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSYRUP / ORAL2008-04-2274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2008-04-2274a2ff9319b5…

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
Childrens Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.30cbaa91-2216-efd2-e063-6294a90aaaed2026-06-07WarningsExact identifier
ndc (package): 51672-2147-1
ndc (package): 51672-2147-8
ndc (product): 51672-2147
ndc11 (package): 51672214701
ndc11 (package): 51672214708
spl set id: 30cbaa91-2216-efd2-e063-6294a90aaaed

Reported adverse events (FAERS/openFDA)#

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