FDA.reportPublic FDA data

CETIRIZINE HYDROCHLORIDE

Manufacturer
QUAGEN PHARMACEUTICALS LLC
Effective date
2025-12-26
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:28:44

Label at a glance#

ProductCETIRIZINE HYDROCHLORIDE
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

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 over  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 onc...

Storage and handling

store between 20° to 25°C (68° to 77°F) Protect from light do not use if carton is opened or if carton tape or bottle wrap imprinted "SEALED FOR YOUR PROTECTION" is broken or missing see bottom panel for lot number and expiration date

Label contents#

Full prescribing information#

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.

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
  • 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.
  • Side effects occur: You may report side effects to FDA at 1-800-FDA-1088.

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 over 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 once daily or 2.5 mL every 12 hours. Do not give more than 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)
  • Protect from light
  • do not use if carton is opened or if carton tape or bottle wrap imprinted "SEALED FOR YOUR PROTECTION" is broken or missing
  • see bottom panel for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

Bubble Gum Syrup: anhydrous citric acid, artificial bubble gum flavor, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose

Grape Syrup: anhydrous citric acid, artificial grape flavor, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose

Questions?

OTC - QUESTIONS SECTION

Call 1-888-344-9603 (toll-free)

SPL UNCLASSIFIED SECTION

Manufactured by:
Quagen Pharmaceuticals LLC
West Caldwell, NJ 07006

51001 & 51002
Rev. 10/18

PRINCIPAL DISPLAY PANEL - Grape Flavor - Container Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cetirizine Hydrochloride Oral Solution, 1 mgmL - Grape Flavor - LabelCetirizine Hydrochloride Oral Solution, 1 mgmL - Grape Flavor - Label

PRINCIPAL DISPLAY PANEL - Grape Flavor-Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cetirizine Hydrochloride Oral Solution, 1 mgmL - Grape Flavor - Container LabelCetirizine Hydrochloride Oral Solution, 1 mgmL - Grape Flavor - Container Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSN9
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCD9
1014673cetirizine HCl 1 MG/ML Oral SyrupSY9
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSY9

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-130370752104067GTIN-13: 0370752104067
EAN-13: 0370752104067
GTIN-12: 370752104067
UPC-A: 370752104067
GTIN storage (14 digits): 00370752104067		containergrapesyrup.jpg

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70752-103-062025-12-26C16284748780-1ba0f9c33-1c34-a910-e053-dadaa90a0b85Children's Cetirizine Hydrochloride Oral Solution, USP 1 mg/mL (Bubble Gum & Grape Flavor) Important: Read all product information before using. Keep this box for important information. This product is intended for use in children. DRUG FACTS
70752-104-062025-12-26C16284748780-1ba0f9c33-1c34-a910-e053-dadaa90a0b85Children's Cetirizine Hydrochloride Oral Solution, USP 1 mg/mL (Bubble Gum & Grape Flavor) Important: Read all product information before using. Keep this box for important information. This product is intended for use in children. DRUG FACTS
70752-103-062025-01-30C16284748780-1ba0f9c33-1c34-a910-e053-dadaa90a0b85Children's Cetirizine Hydrochloride Oral Solution, USP 1 mg/mL (Bubble Gum & Grape Flavor) Important: Read all product information before using. Keep this box for important information. This product is intended for use in children. DRUG FACTS
70752-104-062025-01-30C16284748780-1ba0f9c33-1c34-a910-e053-dadaa90a0b85Children's Cetirizine Hydrochloride Oral Solution, USP 1 mg/mL (Bubble Gum & Grape Flavor) Important: Read all product information before using. Keep this box for important information. This product is intended for use in children. DRUG FACTS
70752-103-062023-02-02C16284748780-1ba0f9c33-1c34-a910-e053-dadaa90a0b85Children's Cetirizine Hydrochloride Oral Solution, USP 1 mg/mL (Bubble Gum & Grape Flavor) Important: Read all product information before using. Keep this box for important information. This product is intended for use in children. DRUG FACTS
70752-104-062023-02-02C16284748780-1ba0f9c33-1c34-a910-e053-dadaa90a0b85Children's Cetirizine Hydrochloride Oral Solution, USP 1 mg/mL (Bubble Gum & Grape Flavor) Important: Read all product information before using. Keep this box for important information. This product is intended for use in children. DRUG FACTS
70752-103-062023-01-30C16284748780-1ba0f9c33-1c34-a910-e053-dadaa90a0b85Children's Cetirizine Hydrochloride Oral Solution, USP 1 mg/mL (Bubble Gum & Grape Flavor) Important: Read all product information before using. Keep this box for important information. This product is intended for use in children. DRUG FACTS
70752-104-062023-01-30C16284748780-1ba0f9c33-1c34-a910-e053-dadaa90a0b85Children's Cetirizine Hydrochloride Oral Solution, USP 1 mg/mL (Bubble Gum & Grape Flavor) Important: Read all product information before using. Keep this box for important information. This product is intended for use in children. DRUG FACTS
70752-104-062021-12-30C16284748780-1ba0f9c33-1c34-a910-e053-dadaa90a0b85Children's Cetirizine Hydrochloride Oral Solution, USP 1 mg/mL (Bubble Gum & Grape Flavor) Important: Read all product information before using. Keep this box for important information. This product is intended for use in children. DRUG FACTS
70752-104-062021-01-29C16284748780-1ba0f9c33-1c34-a910-e053-dadaa90a0b85Children's Cetirizine Hydrochloride Oral Solution, USP 1 mg/mL (Bubble Gum & Grape Flavor) Important: Read all product information before using. Keep this box for important information. This product is intended for use in children. DRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70752-103-06CETIRIZINE HYDROCHLORIDE1 in 1 CARTONSOLUTION19
70752-103-06CETIRIZINE HYDROCHLORIDE118 mL in 1 BOTTLE, PLASTICSOLUTION1189
70752-104-06CETIRIZINE HYDROCHLORIDE1 in 1 CARTONSOLUTION19
70752-104-06CETIRIZINE HYDROCHLORIDE118 mL in 1 BOTTLE, PLASTICSOLUTION1189

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70752-104-06ML - Milliliter70752-104c0e4c4cd-17b2-4d07-b170-2e97354e1ccd12022-12-07

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70752-10370752-103-06
70752-10470752-104-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETIRIZINE HYDROCHLORIDE64O047KTOAACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
CETIRIZINE HYDROCHLORIDE64O047KTOAACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT

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 44.

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
A212266-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2019-05-16

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 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A212266-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2019-05-16c2088c7a36db…
2026-09-14 22:38:342026-08A212266-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2019-05-1684e616aacf4f…
2026-08-18 06:07:402026-07A212266-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2019-05-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212266-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2019-05-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212266-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2019-05-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A212266-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2019-05-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212266-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2019-05-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212266-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2019-05-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212266-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2019-05-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212266-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2019-05-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212266-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2019-05-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212266-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2019-05-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212266-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2019-05-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212266-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2019-05-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212266-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2019-05-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212266-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2019-05-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212266-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2019-05-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212266-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2019-05-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212266-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2019-05-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212266-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2019-05-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A212266-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2019-05-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A212266-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2019-05-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A212266-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2019-05-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A212266-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2019-05-1687673890dc5c…
2021-03-12 10:30 UTC2021-03A212266-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2019-05-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A212266-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2019-05-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11A212266-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2019-05-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12A212266-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2019-05-163f01610625f2…
2019-09-15 20:21 UTC2019-09A212266-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2019-05-16b00525d2431f…
2019-07-19 19:46 UTC2019-07A212266-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2019-05-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A212266-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2019-05-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A212266-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2019-05-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A212266-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2019-05-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A212266-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2019-05-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A212266-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2019-05-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A212266-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2019-05-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A212266-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2019-05-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A212266-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2019-05-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A212266-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2019-05-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A212266-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2019-05-163a93d1ddd44b…

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 HYDROCHLORIDEQUAGEN PHARMACEUTICALS LLC9163cd2e-0be7-4009-b905-729014773d6e2025-12-26WarningsExact identifier
ndc (package): 70752-104-06
ndc (package): 70752-103-06
ndc (product): 70752-103
ndc (product): 70752-104
ndc11 (package): 70752010406
ndc11 (package): 70752010306
spl id: eb119bad-6e21-4378-a556-41b1b790d84c
spl set id: 9163cd2e-0be7-4009-b905-729014773d6e

Reported adverse events (FAERS/openFDA)#

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