FDA.reportPublic FDA data

Cetirizine Hydrochloride Oral Solution 1 mg/mL

Manufacturer
APOZEAL PHARMACEUTICALS INC
Effective date
2026-05-18
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:57:57

Label at a glance#

ProductCetrizine Hydrochloride
Active ingredientCETIRIZINE HYDROCHLORIDE
Label structure11 sections

Indications and uses

temporarily relieves these symptoms due to hay fever or upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat

Dosage and administration

use only with enclosed dosing cup  adults and children 6 years and over: 1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours.  adults 65 years and over: 1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours.  children 2 to under 6 years of age: 1/2 teaspoonful (2.5 mL) once daily. I...

Storage and handling

Store between 20° to 25°C (68° to 77°F).  Excursions permitted to 15°–30°C (59°–86°F) [see USP Controlled Room Temperature]. Tamper Evident  Do not use if foil seal over mouth of the bottle is torn, broken or missing Dosing cup should be washed and left to air dry after each use.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 5 mL teaspoonful)       Purpose

OTC - ACTIVE INGREDIENT SECTION

Cetirizine HCl 5 mg----------------------------------Antihistamine

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms due to hay fever or 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

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 
  • adults and children 6 years and over: 1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours. 
  • adults 65 years and over: 1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours. 
  • children 2 to under 6 years of age: 1/2 teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or 1/2 teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours. 
  • children under 2 years of age: ask a doctor 
  • consumers with liver or kidney disease: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • Store between 20° to 25°C (68° to 77°F). Excursions permitted to 15°–30°C (59°–86°F) [see USP Controlled Room Temperature].
  • Tamper Evident 
  • Do not use if foil seal over mouth of the bottle is torn, broken or missing
  • Dosing cup should be washed and left to air dry after each use.

Inactive ingredients

INACTIVE INGREDIENT SECTION

glacial acetic acid, glycerine, grape flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate, sucrose

Questions or comments?

OTC - QUESTIONS SECTION

1-833-688-7848

*This product is not manufactured or distributed by McNeil Consumer Healthcare, Division of McNeil-PPC, Inc., distributor of Children’s Zyrtec®.

SPL UNCLASSIFIED SECTION

Distributed by:
Apozeal Pharmaceuticals Inc.
Hartel St, Levittown PA 19057

PRINCIPAL DISPLAY PANEL 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 83745-188-12

Cetirizine Hydrochloride Oral Solution, USP

1mg/mL

Grape Flavored Syrup

120 mL

containerlabel120containerlabel120

NDC 83745-188-24

Cetirizine Hydrochloride Oral Solution, USP

1mg/mL

Grape Flavored Syrup

120 mL

containerlabel240mlcontainerlabel240ml

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSN5
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCD5
1014673cetirizine HCl 1 MG/ML Oral SyrupSY5
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSY5

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130383745188128GTIN-13: 0383745188128
EAN-13: 0383745188128
GTIN-12: 383745188128
UPC-A: 383745188128
GTIN storage (14 digits): 00383745188128		containerlabel120ml.jpg
BarcodeEAN-130383745188241GTIN-13: 0383745188241
EAN-13: 0383745188241
GTIN-12: 383745188241
UPC-A: 383745188241
GTIN storage (14 digits): 00383745188241		containerlabel240ml.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83745-188-04Cetrizine Hydrochloride118 mL in 1 BOTTLESOLUTION1185
83745-188-04Cetrizine Hydrochloride1 in 1 CARTONSOLUTION15
83745-188-08Cetrizine Hydrochloride1 in 1 CARTONSOLUTION15
83745-188-08Cetrizine Hydrochloride237 mL in 1 BOTTLESOLUTION2375
83745-188-12Cetrizine Hydrochloride120 mL in 1 BOTTLE, PLASTICSOLUTION1205
83745-188-16Cetrizine Hydrochloride473 mL in 1 BOTTLESOLUTION4735
83745-188-16Cetrizine Hydrochloride1 in 1 CARTONSOLUTION15
83745-188-24Cetrizine Hydrochloride240 mL in 1 BOTTLE, PLASTICSOLUTION2405
83745-188-48Cetrizine Hydrochloride480 mL in 1 BOTTLE, PLASTICSOLUTION4805

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83745-188-04ML - Milliliter83745-188198f4bca-001b-484c-be58-f700eb8ce4ed12026-02-05

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
83745-18883745-188-04, 83745-188-08, 83745-188-16, 83745-188-12, 83745-188-24, 83745-188-48

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETIRIZINE HYDROCHLORIDE64O047KTOAACTIB
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM ACETATE4550K0SC9BIACT
GRAPE6X543N684KIACT
ACETIC ACIDQ40Q9N063PIACT
SUCROSEC151H8M554IACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42026-04-26monthly-update2026-06-03 18:00:44
22026-01-31monthly-update2026-06-03 17:56:03

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
A090474-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEFCETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2009-03-30
A090474-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2009-03-30

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 22:38:342026-08A090474-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2009-03-3084e616aacf4f…
2026-09-14 22:38:342026-08A090474-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2009-03-3084e616aacf4f…
2026-08-18 06:07:402026-07A090474-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2009-03-30caaa826d4ba7…
2026-08-18 06:07:402026-07A090474-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2009-03-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090474-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2009-03-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090474-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2009-03-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090474-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2009-03-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090474-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2009-03-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A090474-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2009-03-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090474-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2009-03-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090474-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2009-03-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090474-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2009-03-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090474-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2009-03-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090474-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2009-03-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090474-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2009-03-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090474-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2009-03-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090474-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2009-03-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090474-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2009-03-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090474-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2009-03-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090474-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2009-03-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090474-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2009-03-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090474-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2009-03-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090474-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2009-03-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A090474-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2009-03-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090474-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2009-03-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090474-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2009-03-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090474-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2009-03-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090474-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2009-03-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090474-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2009-03-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090474-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2009-03-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090474-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2009-03-308072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090474-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2009-03-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090474-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSYRUP / ORAL2009-03-305c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090474-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2009-03-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090474-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSYRUP / ORAL2009-03-305d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090474-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2009-03-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090474-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSYRUP / ORAL2009-03-304b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090474-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2009-03-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090474-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSYRUP / ORAL2009-03-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090474-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2009-03-3074a2ff9319b5…

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
Cetrizine HydrochlorideCETIRIZINE HYDROCHLORIDEAPOZEAL PHARMACEUTICALS INC9c0549cf-4c93-45d9-9eac-3948fa45554e2026-05-18WarningsExact identifier
ndc (package): 83745-188-12
ndc (package): 83745-188-16
ndc (package): 83745-188-48
ndc (package): 83745-188-04
ndc (package): 83745-188-24
ndc (package): 83745-188-08
ndc (product): 83745-188
ndc11 (package): 83745018808
ndc11 (package): 83745018816
ndc11 (package): 83745018812
ndc11 (package): 83745018804
ndc11 (package): 83745018824
ndc11 (package): 83745018848
spl id: 6b714ab7-ee3a-4b6a-ab4b-de3c2b2b2499
spl set id: 9c0549cf-4c93-45d9-9eac-3948fa45554e

Reported adverse events (FAERS/openFDA)#

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