Children's Cetirizine Hydrochloride Chewable Tablets Antihistamine Drug Facts

Manufacturer: Jubilant Cadista Pharmaceuticals Inc. | Jubilant Generics Limited | Jubilant Generics Limited, Roorkee
Effective date: 2019-12-30
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 23:02:37

Label at a glance#

Productcetirizine hydrochloride

Active ingredientCetirizine Hydrochloride

Label structure13 sections

Indications and uses

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

Dosage and administration

● may be taken with and without water For Cetirizine Hydrochloride Chewable Tablets 5 mg adults and children 6 years and over 1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours adults 65 years and over 1 tablet once a day; do not take more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doc...

Label contents#

Full prescribing information#

Active Ingredient (in each chewable tablet)

OTC - ACTIVE INGREDIENT SECTION

Cetirizine Hydrochloride 5 mg

Cetirizine Hydrochloride 10 mg

Purpose

OTC - PURPOSE SECTION

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

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 occuring. 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 taking transquillizers or sedatives

OTC - ASK DOCTOR/PHARMACIST 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

Stop use and ask 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

Directions:

DOSAGE & ADMINISTRATION SECTION

● may be taken with and without water

For Cetirizine Hydrochloride Chewable Tablets 5 mg

adults and children 6 years and over	1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours
adults 65 years and over	1 tablet once a day; do not take more than 1 tablet in 24 hours
children under 6 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Cetirizine Hydrochloride Chewable Tablets 10 mg

adults and children 6 years and over	one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.
adults 65 years and over	ask a doctor
children under 6 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Other information:

store between 20º to 25º C (68º to 77º F).
Phenylketonurics: Contains 1.68 mg Phenylalanine (a component of Aspartame) per 5 mg
Phenylketonurics: Contains 3.36 mg Phenylalanine (a component of Aspartame) per 10 mg
do not use if carton is opened or if blister unit is broken.
see bottom panel for lot number and expiration date.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

acesulfame potassium, artificial & natural flavors,aspartame, betadex, colloidal silicon dioxide, croscarmellose sodium, dl-alpha-tocopherol, ethyl cellulose, FD&C yellow # 6 aluminum lake, fumaric acid, hypromellose, magnesium stearate, mannitol, maltodextrin, microcrystalline cellulose and talc.

Questions? call 1-800-313-4623

OTC - QUESTIONS SECTION

Manufactured by:
Jubilant Generics Ltd.
Roorkee-247661, India

Marketed by:
Jubilant Cadista Pharmaceuticals Inc.
Salisbury, MD 21801, USA

Revised : November / 2014

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CADISTA                                                               NDC 59746-285-33

Children's
Cetirizine Hydrochloride Chewable Tablets 5 mg
Antihistamine

Phenylketonurics: contains 1.68 mg Phenyalanine (a component of Aspartame ) per 5 mg tablets.

HIVES Relief
24 hour Relief of Itching due to hives

6 yrs. & older 5 mg each

TAMPER EVIDENT : Do not use if blister unit is broken or torn.

30 Chewable Tablets                                                                              Orange Chewables
5 mg each

Cetirizine Hydrochloride Chewable Tablets 5 mg Hives Relief

CADISTA NDC 59746-286-33

Children's
Cetirizine Hydrochloride Chewable Tablets 10 mg
Antihistamine

Phenylketonurics: contains 3.36 mg phenyalanine (a component of Aspartame) per 10 mg tablets.

HIVES Relief
24 hour Relief of Itching due to hives

6 yrs. & older 10 mg each

TAMPER EVIDENT : Do not use if blister unit is broken or torn.

30 Chewable Tablets Orange Chewables
10 mg each

Cetirizine Hydrochloride Chewable Tablets 10 mg Hives Relief

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1014674	cetirizine HCl 10 MG Chewable Tablet	PSN	2
1014643	cetirizine HCl 5 MG Chewable Tablet	PSN	2
1014674	cetirizine hydrochloride 10 MG Chewable Tablet	SCD	2
1014643	cetirizine hydrochloride 5 MG Chewable Tablet	SCD	2

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
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35be	Product name	1	20200304
a255659f-db40-429d-8c07-5f173f330d9c	Product name	1	20190402

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
59746-285-33	2023-01-30	C162847	48780-1	f386c649-cbc3-0266-e053-dadaa90a7c1a	Children's Cetirizine Hydrochloride Chewable Tablets Antihistamine Drug Facts
59746-286-33	2023-01-30	C162847	48780-1	f386c649-cbc3-0266-e053-dadaa90a7c1a	Children's Cetirizine Hydrochloride Chewable Tablets Antihistamine Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
59746-285-33	cetirizine hydrochloride	10 in 1 BLISTER PACK	TABLET, CHEWABLE	10	2
59746-285-33	cetirizine hydrochloride	3 in 1 CARTON	TABLET, CHEWABLE	3	2
59746-286-33	cetirizine hydrochloride	10 in 1 BLISTER PACK	TABLET, CHEWABLE	10	2
59746-286-33	cetirizine hydrochloride	3 in 1 CARTON	TABLET, CHEWABLE	3	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59746-285	CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE) TABLET, CHEWABLE [JUBILANT CADISTA PHARMACEUTICALS INC.]	2	Legacy NDC, 2 package rows	20191231_fd6dac8a-e66a-63bd-6c26-23f7dfe00215.zip
59746-286	CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE) TABLET, CHEWABLE [JUBILANT CADISTA PHARMACEUTICALS INC.]	2	Legacy NDC, 2 package rows	20191231_fd6dac8a-e66a-63bd-6c26-23f7dfe00215.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59746-285-32	EA - Each	59746-285	4709384b-f4f1-4d26-b7c4-fb38d2030531	1	2017-09-11
59746-286-32	EA - Each	59746-286	3debc694-8a05-4f4b-ab1d-e63647ea6431	1	2017-09-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Cetirizine Hydrochloride	ACTIVE INGREDIENT	64O047KTOA	1
Cetirizine	ACTIVE MOIETY	YO7261ME24	1
.alpha.-tocopherol, Dl-	INACTIVE INGREDIENT	7QWA1RIO01	1
Acesulfame Potassium	INACTIVE INGREDIENT	23OV73Q5G9	1
Aspartame	INACTIVE INGREDIENT	Z0H242BBR1	1
Betadex	INACTIVE INGREDIENT	JV039JZZ3A	1
Cellulose, Microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	1
Croscarmellose Sodium	INACTIVE INGREDIENT	M28OL1HH48	1
Ethylcelluloses	INACTIVE INGREDIENT	7Z8S9VYZ4B	1
Fd&c Yellow No. 6	INACTIVE INGREDIENT	H77VEI93A8	1
Fumaric Acid	INACTIVE INGREDIENT	88XHZ13131	1
Hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	1
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	1
Maltodextrin	INACTIVE INGREDIENT	7CVR7L4A2D	1
Mannitol	INACTIVE INGREDIENT	3OWL53L36A	1
Silicon Dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
Talc	INACTIVE INGREDIENT	7SEV7J4R1U	1

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

cetirizine hydrochloride
Cetirizine
Acesulfame Potassium
Aspartame
Betadex
Silicon Dioxide
Croscarmellose Sodium
.alpha.-tocopherol, Dl-
Ethylcelluloses
Fd&c Yellow No. 6
Fumaric Acid
Hypromelloses
Magnesium Stearate
Mannitol
Maltodextrin
Cellulose, Microcrystalline
Talc

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
59746-285	59746-285-33
59746-286	59746-286-33

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Cetirizine Hydrochloride	64O047KTOA	ACTIB
Acesulfame Potassium	23OV73Q5G9	IACT
Aspartame	Z0H242BBR1	IACT
Betadex	JV039JZZ3A	IACT
Silicon Dioxide	ETJ7Z6XBU4	IACT
Croscarmellose Sodium	M28OL1HH48	IACT
.alpha.-tocopherol, Dl-	7QWA1RIO01	IACT
Ethylcelluloses	7Z8S9VYZ4B	IACT
Fd&c Yellow No. 6	H77VEI93A8	IACT
Fumaric Acid	88XHZ13131	IACT
Hypromelloses	3NXW29V3WO	IACT
Magnesium Stearate	70097M6I30	IACT
Mannitol	3OWL53L36A	IACT
Maltodextrin	7CVR7L4A2D	IACT
Cellulose, Microcrystalline	OP1R32D61U	IACT
Talc	7SEV7J4R1U	IACT
Cetirizine Hydrochloride	64O047KTOA	ACTIB
Acesulfame Potassium	23OV73Q5G9	IACT
Aspartame	Z0H242BBR1	IACT
Betadex	JV039JZZ3A	IACT
Silicon Dioxide	ETJ7Z6XBU4	IACT
Croscarmellose Sodium	M28OL1HH48	IACT
.alpha.-tocopherol, Dl-	7QWA1RIO01	IACT
Ethylcelluloses	7Z8S9VYZ4B	IACT
Fd&c Yellow No. 6	H77VEI93A8	IACT
Fumaric Acid	88XHZ13131	IACT
Hypromelloses	3NXW29V3WO	IACT
Magnesium Stearate	70097M6I30	IACT
Mannitol	3OWL53L36A	IACT
Maltodextrin	7CVR7L4A2D	IACT
Cellulose, Microcrystalline	OP1R32D61U	IACT
Talc	7SEV7J4R1U	IACT

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 7 · 386 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER / ORAL		602 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Aspartame	ASPARTAME	Z0H242BBR1	POWDER / ORAL		63 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
Fd&c Yellow No. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET / ORAL	60.02 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	TABLET, ORALLY DISINTEGRATING / ORAL		80 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Cellulose, Microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / SUBLINGUAL	43.2 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
Hypromelloses	HYPROMELLOSE	3NXW29V3WO	GRANULE, FOR SUSPENSION / ORAL	1.7 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
Aspartame	ASPARTAME	Z0H242BBR1	TABLET, ORALLY DISINTEGRATING / ORAL		180 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	PASTE / DENTAL	34 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
Mannitol	MANNITOL	3OWL53L36A	INJECTION / INTRAVENOUS		15200 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
.alpha.-tocopherol, Dl-	.ALPHA.-TOCOPHEROL, DL-	7QWA1RIO01	TABLET, CHEWABLE / ORAL	0.02 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
Croscarmellose Sodium	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, EXTENDED RELEASE / ORAL		392 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Mannitol	MANNITOL	3OWL53L36A	POWDER, FOR SUSPENSION / INTRAMUSCULAR	6.75 %w/v		Exact identifier — unii candidate 65 equally ranked IID candidates
Ethylcelluloses	ETHYLCELLULOSE	7Z8S9VYZ4B	TABLET / ORAL		300 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
Croscarmellose Sodium	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, FILM COATED / ORAL		330 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	CAPSULE, DELAYED RELEASE / ORAL		1060 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Mannitol	MANNITOL	3OWL53L36A	CAPSULE, EXTENDED RELEASE / ORAL		160 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
Mannitol	MANNITOL	3OWL53L36A	SOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC	4.35 %w/w		Exact identifier — unii candidate 65 equally ranked IID candidates
Mannitol	MANNITOL	3OWL53L36A	SUSPENSION/ DROPS / TOPICAL	0.3 %w/v		Exact identifier — unii candidate 65 equally ranked IID candidates
Acesulfame Potassium	ACESULFAME POTASSIUM	23OV73Q5G9	GUM, CHEWING / BUCCAL		147 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
Fd&c Yellow No. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Fumaric Acid	FUMARIC ACID	88XHZ13131	TABLET, EXTENDED RELEASE / ORAL		84 mg	Exact identifier — unii candidate 7 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	TABLET, CHEWABLE / ORAL		202 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Fd&c Yellow No. 6	FD&C YELLOW NO. 6	H77VEI93A8	CAPSULE, EXTENDED RELEASE / ORAL	4.59 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
Mannitol	MANNITOL	3OWL53L36A	TABLET, CHEWABLE / ORAL		3726 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, COATED / ORAL		176 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Maltodextrin	MALTODEXTRIN	7CVR7L4A2D	TABLET, CHEWABLE / ORAL	292 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
Hypromelloses	HYPROMELLOSE	3NXW29V3WO	JELLY / TOPICAL	NA		Exact identifier — unii candidate 27 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	TABLET, FILM COATED / ORAL		91 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Mannitol	MANNITOL	3OWL53L36A	INJECTION, POWDER, FOR SUSPENSION / SUBCUTANEOUS		180 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	TROCHE / ORAL		315 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Mannitol	MANNITOL	3OWL53L36A	SOLUTION, GEL FORMING / DROPS / OPHTHALMIC		4 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, DELAYED RELEASE / ORAL		144 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	LOZENGE / ORAL		420 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Mannitol	MANNITOL	3OWL53L36A	TABLET, ORALLY DISINTEGRATING / ORAL		4364 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
Maltodextrin	MALTODEXTRIN	7CVR7L4A2D	CAPSULE / ORAL		200 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
Mannitol	MANNITOL	3OWL53L36A	SUSPENSION, EXTENDED RELEASE / ORAL	2464.6 mg		Exact identifier — unii candidate 65 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE / ORAL	5000 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
Ethylcelluloses	ETHYLCELLULOSE	7Z8S9VYZ4B	CAPSULE, EXTENDED RELEASE / ORAL		153 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
Mannitol	MANNITOL	3OWL53L36A	TABLET, COATED / ORAL	177.7 mg		Exact identifier — unii candidate 65 equally ranked IID candidates
Mannitol	MANNITOL	3OWL53L36A	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS		181 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
Aspartame	ASPARTAME	Z0H242BBR1	TABLET / SUBLINGUAL		8 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	PELLET / ORAL		24 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	INSERT / VAGINAL		8 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / VAGINAL	8 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	DROPS / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
Cellulose, Microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		1576 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Cellulose, Microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IMPLANT / INTRAVITREAL	1.66 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
Cellulose, Microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	CAPSULE, DELAYED RELEASE / ORAL		366 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Acesulfame Potassium	ACESULFAME POTASSIUM	23OV73Q5G9	SOLUTION / DENTAL	0.12 %w/w		Exact identifier — unii candidate 17 equally ranked IID candidates
.alpha.-tocopherol, Dl-	.ALPHA.-TOCOPHEROL, DL-	7QWA1RIO01	AEROSOL, FOAM / TOPICAL	0.02 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
Mannitol	MANNITOL	3OWL53L36A	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS		658 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		69 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Fd&c Yellow No. 6	FD&C YELLOW NO. 6	H77VEI93A8	CAPSULE, COATED PELLETS / ORAL	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
Croscarmellose Sodium	CROSCARMELLOSE SODIUM	M28OL1HH48	CAPSULE, EXTENDED RELEASE / ORAL		53 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Aspartame	ASPARTAME	Z0H242BBR1	LOZENGE / ORAL		136 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
Fd&c Yellow No. 6	FD&C YELLOW NO. 6	H77VEI93A8	SUSPENSION / ORAL		11 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Ethylcelluloses	ETHYLCELLULOSE	7Z8S9VYZ4B	CREAM / TOPICAL	NA		Exact identifier — unii candidate 14 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, DELAYED RELEASE / ORAL	3.2 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
Cellulose, Microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	GRANULE, DELAYED RELEASE / ORAL	789.6 mg		Exact identifier — unii candidate 28 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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A091116-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG	TABLET, CHEWABLE / ORAL	2015-02-19
A091116-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, CHEWABLE / ORAL	2015-02-19
A091116-003	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	5MG	TABLET, CHEWABLE / ORAL	2015-02-19
A091116-004	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, CHEWABLE / ORAL	2015-02-19

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 5 · 172 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	A091116-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL	2015-02-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091116-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	2015-02-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091116-003	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET, CHEWABLE / ORAL	2015-02-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091116-004	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET, CHEWABLE / ORAL	2015-02-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091116-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL	2015-02-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091116-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	2015-02-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091116-003	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET, CHEWABLE / ORAL	2015-02-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091116-004	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET, CHEWABLE / ORAL	2015-02-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091116-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL	2015-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091116-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	2015-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091116-003	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET, CHEWABLE / ORAL	2015-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091116-004	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET, CHEWABLE / ORAL	2015-02-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091116-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL	2015-02-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091116-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	2015-02-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091116-003	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET, CHEWABLE / ORAL	2015-02-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091116-004	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET, CHEWABLE / ORAL	2015-02-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091116-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL	2015-02-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091116-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	2015-02-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091116-003	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET, CHEWABLE / ORAL	2015-02-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091116-004	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET, CHEWABLE / ORAL	2015-02-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091116-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL	2015-02-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091116-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	2015-02-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091116-003	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET, CHEWABLE / ORAL	2015-02-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091116-004	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET, CHEWABLE / ORAL	2015-02-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091116-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL	2015-02-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091116-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	2015-02-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091116-003	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET, CHEWABLE / ORAL	2015-02-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091116-004	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET, CHEWABLE / ORAL	2015-02-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091116-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL	2015-02-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091116-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	2015-02-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091116-003	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET, CHEWABLE / ORAL	2015-02-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091116-004	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET, CHEWABLE / ORAL	2015-02-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091116-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL	2015-02-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091116-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	2015-02-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091116-003	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET, CHEWABLE / ORAL	2015-02-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091116-004	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET, CHEWABLE / ORAL	2015-02-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091116-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL	2015-02-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091116-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	2015-02-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091116-003	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET, CHEWABLE / ORAL	2015-02-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091116-004	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET, CHEWABLE / ORAL	2015-02-19	`5bbf6a4d5a75…`

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
074eae14-638f-49df-9574-8936813a2d00			fd6dac8a-e66a-63bd-6c26-23f7dfe00215	2019-12-30	Warnings	Exact identifier spl id: 074eae14-638f-49df-9574-8936813a2d00 spl set id: fd6dac8a-e66a-63bd-6c26-23f7dfe00215

Reported adverse events (FAERS/openFDA)#

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