Cetirizine Hydrochloride Oral Solution - Allergy

Manufacturer: A-S Medication Solutions
Effective date: 2021-04-16
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 23:39:45

Label at a glance#

ProductCetirizine Hydrochloride

Active ingredientCETIRIZINE HYDROCHLORIDE

Label structure14 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 (tsp)(5 mL) or 2 teaspoonfuls (tsp)(10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (tsp)(10 mL) in 24 hours. adults 65 years and over 1 teaspoonful (tsp)(5 mL) once daily; do not take more than 1 teaspoonful (tsp)(5 mL) in 24 hours. children 2 to under 6 years of age 1/2 teaspoonf...

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-844-834-0530

PhoneLabel contact1-888-974-5279

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each 5 mL (teaspoonful(tsp)): Cetirizine HCl 5 mg

OTC - PURPOSE SECTION

Purpose: 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

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.

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 (tsp)(5 mL) or 2 teaspoonfuls (tsp)(10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (tsp)(10 mL) in 24 hours.
adults 65 years and over	1 teaspoonful (tsp)(5 mL) once daily; do not take more than 1 teaspoonful (tsp)(5 mL) in 24 hours.
children 2 to under 6 years of age	1/2 teaspoonful (tsp)(2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (tsp)(5 mL) once daily or 1/2 teaspoonful (tsp)(2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (tsp)(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
Store between 20º to 25ºC (68º to 77ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

calcium acetate, grape flavor, glacial acetic acid, glycerin, methylparaben, propylene glycol, propylparaben, purified water.

Questions?

OTC - QUESTIONS SECTION

Call 1-844-834-0530

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each 5 mL (teaspoonful)): Cetirizine HCl 5 mg

OTC - PURPOSE SECTION

Purpose: Antihistamine

Uses

INDICATIONS & USAGE SECTION

relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.

Warnings

WARNINGS SECTION

Severe Allergy Warning: Get emergency help immediately if you have hives along with any of the following symptoms:

trouble swallowing
dizziness or loss of consciousness
swelling of tongue
swelling in or around mouth
trouble speaking
drooling
wheezing or problems breathing

These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by health professional immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later.
Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrine injector for “anaphylaxis” or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times.

Do not use

OTC - DO NOT USE SECTION

to prevent hives from any known cause such as:
foods
insect stings
medicines
latex or rubber gloves because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause.
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
hives that are an unusual color, look bruised or blistered
hives that do not itch

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.
symptoms do not improve after 3 days of treatment
the hives have lasted more than 6 weeks

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.

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 under 6 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

Call 1-888-974-5279

SPL UNCLASSIFIED SECTION

Dosing Cup Included

Dosing cup should be washed and left to air dry after each use.

Do not use if carton is open; or if safety seal printed with “SEALED FOR YOUR PROTECTION” around cap of the bottle is broken or missing.

SAVE THIS CARTON FOR FULL LABELING INFORMATION

Cetirizine Hydrochloride

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1014673	cetirizine HCl 5 MG in 5 mL Oral Solution	PSN	3
1014673	cetirizine hydrochloride 1 MG/ML Oral Solution	SCD	3
1014673	cetirizine HCl 1 MG/ML Oral Syrup	SY	3
1014673	cetirizine HCl 5 MG per 5 ML Oral Solution	SY	3

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
CETIRIZINE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
334fe8d2-68fb-4331-a576-420e302ec069	Product name	7	20240320
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35be	Product name	1	20200304
a255659f-db40-429d-8c07-5f173f330d9c	Product name	1	20190402
48747306-602a-42cc-957b-5b0c69158eee	Product name	1	20180604
0441a8f5-3835-497c-aedd-bc78cba56b2a	Product name	1	20150317
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-4379-0	2023-01-30	C162847	48780-1	f386c64a-0c05-0266-e053-dadaa90a7c1a	Cetirizine Hydrochloride Oral Solution - Allergy

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-4379-0	Cetirizine Hydrochloride	120 mL in 1 CARTON	SOLUTION	120		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-4379	CETIRIZINE HYDROCHLORIDE SOLUTION [A-S MEDICATION SOLUTIONS]	3	Legacy NDC, 1 package rows	20210418_8b37052c-c3ec-4cd4-b21c-ac6a7be286a8.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54838-552-40	ML - Milliliter	54838-552	968da55e-f5b7-490c-aebf-c36e735d7a27	1	2012-07-24

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

Cetirizine Hydrochloride
CETIRIZINE
CALCIUM ACETATE
ACETIC ACID
GLYCERIN
METHYLPARABEN
PROPYLENE GLYCOL
PROPYLPARABEN
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
50090-4379	50090-4379-0
54838-552

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CETIRIZINE HYDROCHLORIDE	64O047KTOA	ACTIB
CALCIUM ACETATE	Y882YXF34X	IACT
ACETIC ACID	Q40Q9N063P	IACT
GLYCERIN	PDC6A3C0OX	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
WATER	059QF0KO0R	IACT

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A091130-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL			2011-04-22
A091130-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL			2011-04-22

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A091130-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2011-04-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091130-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2011-04-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091130-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2011-04-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091130-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2011-04-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091130-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2011-04-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091130-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2011-04-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091130-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2011-04-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091130-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2011-04-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091130-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2011-04-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091130-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2011-04-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091130-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2011-04-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091130-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2011-04-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091130-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2011-04-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091130-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2011-04-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091130-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2011-04-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091130-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2011-04-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091130-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2011-04-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091130-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2011-04-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091130-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2011-04-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091130-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2011-04-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091130-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2011-04-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091130-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2011-04-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091130-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2011-04-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091130-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2011-04-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091130-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2011-04-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091130-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2011-04-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091130-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2011-04-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091130-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2011-04-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091130-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2011-04-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091130-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2011-04-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091130-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SOLUTION / ORAL	2011-04-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091130-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	2011-04-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091130-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2011-04-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091130-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SYRUP / ORAL	2011-04-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091130-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2011-04-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091130-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SYRUP / ORAL	2011-04-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091130-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2011-04-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091130-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SYRUP / ORAL	2011-04-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091130-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG/5ML	SYRUP / ORAL	2011-04-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091130-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG/5ML	SYRUP / ORAL	2011-04-22	`74a2ff9319b5…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
c51f93e8-09eb-4d93-be28-c995df65909d			8b37052c-c3ec-4cd4-b21c-ac6a7be286a8	2021-04-16	Warnings	Exact identifier spl id: c51f93e8-09eb-4d93-be28-c995df65909d spl set id: 8b37052c-c3ec-4cd4-b21c-ac6a7be286a8

Reported adverse events (FAERS/openFDA)#

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