FDA.reportPublic FDA data

CETIRIZINE HYDROCHLORIDE - BAJAJ MEDICAL, LLC

Manufacturer
BAJAJ MEDICAL, LLC
Effective date
2026-10-01
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
daily-update
Hydrated at
2026-10-06 02:03:50

Label at a glance#

ProductCETIRIZINE HYDROCHLORIDE
Active ingredientCETIRIZINE HYDROCHLORIDE
Label structure13 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 a 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 once daily or...

Storage and handling

Store between 20º to 25ºC (68º to 77ºF)

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 SECTION

Warnings

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.

OTC - WHEN USING SECTION

When using this product

  • 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.

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. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

  • use only with a 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 over5 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

Store between 20º to 25ºC (68º to 77ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

call toll-free 1-800-581-2528 weekdays

PRINCIPAL DISPLAY PANEL: 4 fl. oz. (120 mL) - NDC 61037-480-02

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 61037-480-02

Children’s Cetirizine Hydrochloride 1 mg/mL Oral Solution, USP

2 yrs. & older

Antihistamine
Grape Flavored

ALLERGY

Indoor and Outdoor Allergies

24 Hour Relief of:
• Sneezing
• Runny Nose
• Itchy, Watery Eyes
• Itchy Throat or Nose

4 fl. oz. (120 mL)

Dosing cup should be washed and left to air dry after each use. Do not use if seal on bottle is broken or missing.

Manufactured by:
Bajaj Medical, LLC
Chicago IL 60609, USA
Issued: 01/2025

4oz14oz1

4oz24oz2

4oz34oz34oz44oz4

4oz54oz5

4oz64oz6

4oz74oz7

PRINCIPAL DISPLAY PANEL: 16 fl. oz. (480 mL) - NDC 61037-480-03

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 61037-480-03

Children’s Cetirizine Hydrochloride 1 mg/mL Oral Solution, USP

2 yrs. & older

Antihistamine
Grape Flavored

ALLERGY

Indoor and Outdoor Allergies


24 Hour Relief of:
• Sneezing
• Runny Nose
• Itchy, Watery Eyes
• Itchy Throat or Nose

16 fl. oz. (480 mL)

Dosing cup should be washed and left to air dry after each use. Do not use if seal on bottle is broken or missing.

Manufactured by:
Bajaj Medical, LLC
Chicago IL 60609, USA
Issued: 01/2025

16oz116oz1

16oz216oz2

16oz316oz3

PRINCIPAL DISPLAY PANEL: 8 fl. oz. (240 mL) - NDC 61037-480-04

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 61037-480-04

Children’s Cetirizine Hydrochloride Oral Solution, USP

1 mg/mL

2 yrs. & older

Antihistamine
Grape Flavored

ALLERGY

Indoor and Outdoor Allergies


24 Hour Relief of:
• Sneezing
• Runny Nose
• Itchy, Watery Eyes
• Itchy Throat or Nose

8 fl. oz. (240 mL)

Dosing cup should be washed and left to air dry after each use. Do not use if seal on bottle is broken or missing.

Manufactured by:
Bajaj Medical, LLC
Chicago IL 60609, USA
Issued: 08/2025

8oz-18oz-1

8oz-28oz-2

8oz-38oz-3

100 Unit-Dose Cups (Each Cup Delivers 5 mL) - NDC 61037-480-12

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 61037-480-12

2 yrs. & older

Children's

Cetirizine Hydrochloride Oral Solution, USP

5 mg/5 mL

Antihistamine

ALLERGY

Do not use if seal on cup is broken or missing.

Indoor and Outdoor Allergies

24 Hour Relief of:

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

100 Unit-Dose Cups

(Each Cup Delivers 5 mL)

Grape Flavored

For Institutional Use Only

Manufactured by:

Bajaj Medical, LLC

Chicago IL 60609, USA

Issued: 10/2026

allergy-5mlallergy-5ml

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

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
61037-48061037-480-02, 61037-480-03, 61037-480-04, 61037-480-06, 61037-480-12

Ingredients#

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

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

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

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42026-08-26daily-update2026-08-29 01:01:27
32025-08-05full-release2026-06-01 01:09:19

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
A091327-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2011-10-17
A091327-002CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEFCETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2011-10-17

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 22:38:342026-08A091327-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2011-10-1784e616aacf4f…
2026-09-14 22:38:342026-08A091327-002CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2011-10-1784e616aacf4f…
2026-08-18 06:07:402026-07A091327-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2011-10-17caaa826d4ba7…
2026-08-18 06:07:402026-07A091327-002CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2011-10-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091327-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2011-10-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091327-002CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2011-10-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091327-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2011-10-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091327-002CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2011-10-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A091327-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2011-10-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091327-002CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2011-10-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091327-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2011-10-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091327-002CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2011-10-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091327-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2011-10-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091327-002CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2011-10-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091327-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2011-10-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091327-002CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2011-10-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091327-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2011-10-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091327-002CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2011-10-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091327-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2011-10-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091327-002CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2011-10-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091327-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2011-10-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091327-002CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2011-10-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091327-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2011-10-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A091327-002CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2011-10-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091327-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2011-10-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091327-002CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2011-10-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091327-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2011-10-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091327-002CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2011-10-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091327-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2011-10-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091327-002CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2011-10-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091327-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2011-10-178072bd15b7f6…
2024-05-31 18:47 UTC2024-05A091327-002CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2011-10-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091327-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2011-10-175c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091327-002CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSYRUP / ORAL2011-10-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091327-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2011-10-175d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091327-002CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSYRUP / ORAL2011-10-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091327-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2011-10-174b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A091327-002CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSYRUP / ORAL2011-10-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091327-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2011-10-1774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091327-002CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSYRUP / ORAL2011-10-1774a2ff9319b5…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDEBAJAJ MEDICAL, LLC36b6d0e4-8da5-9df5-e063-6294a90af3262026-10-01WarningsExact identifier
ndc (product): 61037-480
59fa0fa6-075c-826c-e063-6294a90a72fb36b24a3c-6284-5a6d-e063-6394a90a77432026-08-26WarningsExact identifier
spl set id: 36b24a3c-6284-5a6d-e063-6394a90a7743

Reported adverse events (FAERS/openFDA)#

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