Allergo Kids PLUS

Manufacturer
Plus Distributors LLC
Effective date
2019-02-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:30:37

Label at a glance#

ProductAllergo Kids PLUS
Active ingredientCETIRIZINE HYDROCHLORIDE
Label structure10 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  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 dailly. I...

Storage and handling

store between 20º-25ºC (68º-77ºF)

Label contents#

Full prescribing information#

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
    • sneezing
    • itchy, watery eyes
    • itching of the nose or throat

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 dailly. 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 20º-25ºC (68º-77ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-888-309-9030

Principal Display Panel

SPL UNCLASSIFIED SECTION

Cetirizine Oral Solution 1 mg/mL

Anthistamine

24-hour relief of :

  • Sneezing
  • Runny nose
  • Itchy, watery eyes
  • Itchy nose or throat

For ages 2 years & older

Dye-free

Gluten free

Indoor and outdoor allergies

Grape flavor

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Allergo Kids PLUS
Allergo Kids PLUS

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72828-178-042020-12-14C16284748780-1ab0e2407-2896-f274-e053-dbdaa90a6471Drug Facts
72828-178-042020-09-27C16284748780-1ab0e2407-2896-f274-e053-dbdaa90a6471Drug Facts
72828-178-042020-09-25C16284748780-1ab0e2407-2896-f274-e053-dbdaa90a6471Drug Facts
72828-178-042020-07-22C16284748780-1ab0e2407-2896-f274-e053-dbdaa90a6471Drug Facts

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
72828-17872828-178-04

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

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
4e5fe6ee-45ca-42bc-886b-7ef13012dda73776f3b7-04d2-47d7-83de-bef28eb4241d2020-12-14WarningsExact identifier
spl set id: 3776f3b7-04d2-47d7-83de-bef28eb4241d

Reported adverse events (FAERS/openFDA)#

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