CHILDREN'S CETIRIZINE HYDROCHLORIDE ORAL SOLUTION 1 mg/1 mL Antihistamine

Manufacturer
Chain Drug Consortium, LLC (Premier Value) | Taro Pharmaceuticals U.S.A., Inc. | Taro Pharmaceutical Industries Ltd.
Effective date
2019-01-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:58:28

Label at a glance#

ProductChildrens Cetirizine 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 itchy, watery eyes sneezing 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 older 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 nee...

Storage and handling

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 teaspoonful)

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
  • itchy, watery eyes
  • sneezing
  • 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding:

  • 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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • use only with enclosed dosing cup
adults and children 6 years and over1 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 older1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours.
children 2 to under 6 years of age1/2 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 ageask a doctor
consumers with liver or kidney diseaseask a doctor

Other information

STORAGE AND HANDLING SECTION

  • store between 20° to 25°C (68° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

artificial grape flavor, glacial acetic acid, glycerin, methylparaben, natural and artificial banana flavor, propylene glycol, propylparaben, purified water, sodium acetate (anhydrous), sucrose

Questions?

OTC - QUESTIONS SECTION

Call 1-866-923-4914

SPL UNCLASSIFIED SECTION

Distributed by: Chain Drug Consortium, LLC
2300 NW Corporate BLVD., Suite 115
Boca Raton, FL 33431
Made in Israel

PRINCIPAL DISPLAY PANEL - 120 mL bottle carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68016-023-43

Ages
two years
and older

Compare to
the active ingredient
in Children's Zyrtec®*

Premier
Value
®

CHILDREN'S
CETIRIZINE
HYDROCHLORIDE
ORAL SOLUTION
1 mg/1 mL
Antihistamine

Grape Flavored Syrup

24 hour Allergy Relief of:
Sneezing; Runny Nose;
Itchy,Watery Eyes;
Itchy Throat or Nose

Indoor & Outdoor Allergies

Dosing Cup
Included

PV
PREMIER VALUE GUARANTEE

4 FL OZ (120 mL)

Principal Display Panel - 120 mL bottle carton
Principal Display Panel - 120 mL bottle carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSN2
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCD2
1014673cetirizine HCl 1 MG/ML Oral SyrupSY2
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSY2

DailyMed Pharmacologic Classes#

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

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-023-43Childrens Cetirizine Hydrochloride120 mL in 1 BOTTLESOLUTION1202
68016-023-43Childrens Cetirizine Hydrochloride1 in 1 CARTONSOLUTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-023CHILDRENS CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE) SOLUTION [CHAIN DRUG CONSORTIUM, LLC (PREMIER VALUE)]2Current NDC, Legacy NDC, 2 package rows20190207_b47b0c8b-59d5-4e17-95be-a992c6861ee7.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Cetirizine HydrochlorideACTIVE INGREDIENT64O047KTOA1
CetirizineACTIVE MOIETYYO7261ME241
acetic acidINACTIVE INGREDIENTQ40Q9N063P1
glycerinINACTIVE INGREDIENTPDC6A3C0OX1
methylparabenINACTIVE INGREDIENTA2I8C7HI9T1
propylene glycolINACTIVE INGREDIENT6DC9Q167V31
propylparabenINACTIVE INGREDIENTZ8IX2SC1OH1
sodium acetate anhydrousINACTIVE INGREDIENTNVG71ZZ7P01
sucroseINACTIVE INGREDIENTC151H8M5541
waterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68016-02368016-023-43

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 14 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
propylparabenPROPYLPARABENZ8IX2SC1OHSOLUTION / ORAL100 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
sodium acetate anhydrousSODIUM ACETATE ANHYDROUSNVG71ZZ7P0SOLUTION / ORAL177 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
sodium acetate anhydrousSODIUM ACETATE ANHYDROUSNVG71ZZ7P0SOLUTION / ORAL177 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
acetic acidACETIC ACIDQ40Q9N063PSOLUTION / ORAL10 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
acetic acidACETIC ACIDQ40Q9N063PSOLUTION / ORAL10 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / ORAL22602 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
sucroseSUCROSEC151H8M554SOLUTION / ORAL70000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TSOLUTION / ORAL346 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / ORAL22602 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
sucroseSUCROSEC151H8M554SOLUTION / ORAL70000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHSOLUTION / ORAL100 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TSOLUTION / ORAL346 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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 HYDROCHLORIDEChain Drug Consortium, LLC (Premier Value)b47b0c8b-59d5-4e17-95be-a992c6861ee72019-01-23WarningsExact identifier
ndc (package): 68016-023-43
ndc (product): 68016-023
ndc11 (package): 68016002343
spl id: c067a0f7-cadb-42cb-9bd4-6b901aec98c4
spl set id: b47b0c8b-59d5-4e17-95be-a992c6861ee7

Reported adverse events (FAERS/openFDA)#

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