Cetirizine Hydrochloride Chewable Tablets

Manufacturer: Sun Pharmaceutical Industries, Inc. | Sun Pharmaceutical Industries Limited
Effective date: 2018-10-26
Label type: Human OTC Drug Label
Version: 2
Source: legacy-cache
Hydrated at: 2026-08-02 00:48:18

Label at a glance#

ProductCetirizine Hydrochloride

Active ingredientCETIRIZINE HYDROCHLORIDE

Label structure16 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 or without water For 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 For 10 mg: adults and children 6 years an...

Storage and handling

store between 20° to 25°C (68° to 77°F) do not use if inner safety seal is open or torn see top layer for lot number and expiration date

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-818-4555

Label contents#

Full prescribing information#

Active ingredient (in each chewable tablet)

OTC - ACTIVE INGREDIENT SECTION

For 5 mg:
Cetirizine hydrochloride 5 mg

For 10 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
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 a 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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

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.

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

may be taken with or without water

For 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

For 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

STORAGE AND HANDLING SECTION

store between 20° to 25°C (68° to 77°F)
do not use if inner safety seal is open or torn
see top layer for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, colloidal silicon dioxide, compressible sugar, crospovidone, FD & C Blue No # 2 Aluminum Lake, FD & C Red No # 40 Aluminum Lake, guar gum, magnesium oxide light powder, magnesium stearate, mannitol, microcrystalline cellulose, pregelatinized starch, prosweet N & A flavor powder, talc, tutti frutti flavor

Questions?

SPL UNCLASSIFIED SECTION

Call toll free 1-800-818-4555 weekdays

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

For 5 mg Hives Relief:
Original Prescription Strength
NDC 47335-343-16
Children's
Cetirizine Hydrochloride Chewable Tablets
5 mg
HIVES Relief
Antihistamine
24 hour Relief of ITCHING Due to Hives
Tutti-frutti Flavor
6 yrs. & older
100 CHEWABLE TABLETS
SUN PHARMACEUTICAL INDUSTRIES LTD.

For 10 mg Hives Relief:
Original Prescription Strength
NDC 47335-344-16
Children's
Cetirizine Hydrochloride Chewable Tablets
10 mg
HIVES Relief
Antihistamine
Tutti-frutti Flavor
6 yrs. & older
100 CHEWABLE TABLETS
SUN PHARMACEUTICAL INDUSTRIES LTD.

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0347335344165	GTIN-13: 0347335344165 EAN-13: 0347335344165 GTIN-12: 347335344165 UPC-A: 347335344165 GTIN storage (14 digits): 00347335344165	10mg-hives-relief-1.jpg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
47335-343-83	EA - Each	47335-343	dd3fb5df-57c2-4133-8639-9bc175692699	1	2013-02-13
47335-344-83	EA - Each	47335-344	2f6a2325-3993-475b-ac3a-8bd9cdfb34b7	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
CETIRIZINE HYDROCHLORIDE	ACTIVE INGREDIENT	64O047KTOA	1
CETIRIZINE	ACTIVE MOIETY	YO7261ME24	1
ACESULFAME POTASSIUM	INACTIVE INGREDIENT	23OV73Q5G9	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	1
GUAR GUM	INACTIVE INGREDIENT	E89I1637KE	1
MAGNESIUM OXIDE	INACTIVE INGREDIENT	3A3U0GI71G	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	1

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

Cetirizine Hydrochloride
CETIRIZINE
ACESULFAME POTASSIUM
SILICON DIOXIDE
SUCROSE
CROSPOVIDONE
FD&C BLUE NO. 2
FD&C RED NO. 40
GUAR GUM
MAGNESIUM OXIDE
MAGNESIUM STEARATE
MANNITOL
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
TALC

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
47335-343	47335-343-15, 47335-343-16
47335-344	47335-344-15, 47335-344-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CETIRIZINE HYDROCHLORIDE	64O047KTOA	ACTIB
ACESULFAME POTASSIUM	23OV73Q5G9	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
SUCROSE	C151H8M554	IACT
CROSPOVIDONE	68401960MK	IACT
FD&C BLUE NO. 2	L06K8R7DQK	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
GUAR GUM	E89I1637KE	IACT
MAGNESIUM OXIDE	3A3U0GI71G	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MANNITOL	3OWL53L36A	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
STARCH, CORN	O8232NY3SJ	IACT
TALC	7SEV7J4R1U	IACT
CETIRIZINE HYDROCHLORIDE	64O047KTOA	ACTIB
ACESULFAME POTASSIUM	23OV73Q5G9	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
SUCROSE	C151H8M554	IACT
CROSPOVIDONE	68401960MK	IACT
FD&C BLUE NO. 2	L06K8R7DQK	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
GUAR GUM	E89I1637KE	IACT
MAGNESIUM OXIDE	3A3U0GI71G	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MANNITOL	3OWL53L36A	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
STARCH, CORN	O8232NY3SJ	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 · 366 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
MANNITOL	MANNITOL	3OWL53L36A	LOZENGE / ORAL		20546 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	INJECTION, SOLUTION / INTRAVENOUS	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	SOLUTION / SUBCUTANEOUS	4.54 %w/v		Exact identifier — unii candidate 65 equally ranked IID candidates
ACESULFAME POTASSIUM	ACESULFAME POTASSIUM	23OV73Q5G9	TABLET / ORAL		111 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
GUAR GUM	GUAR GUM	E89I1637KE	TABLET / SUBLINGUAL	1.1 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET / BUCCAL	109 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, DELAYED RELEASE PARTICLES / ORAL		580 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C BLUE NO. 2	FD&C BLUE NO. 2	L06K8R7DQK	TABLET, EXTENDED RELEASE / ORAL	2.78 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, CHEWABLE / ORAL		254 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET / SUBLINGUAL		495 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FOR SUSPENSION / ORAL		20100 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / BUCCAL	16.6 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	GRANULE / ORAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	SOLUTION / RECTAL	35.42 %w/v		Exact identifier — unii candidate 48 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CAPSULE, EXTENDED RELEASE / ORAL		194 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / TOPICAL		6 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	PELLET / ORAL		1140 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TROCHE / ORAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	INJECTION, SOLUTION / SUBCUTANEOUS		99 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MAGNESIUM OXIDE	MAGNESIUM OXIDE	3A3U0GI71G	TABLET, FILM COATED / ORAL		80 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	CAPSULE, EXTENDED RELEASE / ORAL		1246 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE, COATED / ORAL		87 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, ORALLY DISINTEGRATING / ORAL		68 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET / SUBLINGUAL	32.4 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	SUSPENSION / ORAL		1600 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	DROPS / ORAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, COATED / ORAL		920 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	POWDER, FOR SOLUTION / ORAL		690 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	GRANULE, FOR SUSPENSION / ORAL		278 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE, EXTENDED RELEASE / ORAL		5119 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	CONCENTRATE / INTRAVENOUS		220 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	SUSPENSION/ DROPS / ORAL		3750 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET, ORALLY DISINTEGRATING / ORAL		4364 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	PASTILLE / ORAL	426 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, CHEWABLE / ORAL		1725 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C BLUE NO. 2	FD&C BLUE NO. 2	L06K8R7DQK	TABLET, FILM COATED / ORAL		2 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	900 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	LOZENGE / BUCCAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	POWDER, FOR SOLUTION / ORAL		38666 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	SUSPENSION, EXTENDED RELEASE / ORAL	2464.6 mg		Exact identifier — unii candidate 65 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET / SUBLINGUAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	INJECTION / SUBCUTANEOUS		675 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
FD&C BLUE NO. 2	FD&C BLUE NO. 2	L06K8R7DQK	CAPSULE / ORAL		4 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / SUBLINGUAL	43.2 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	GRANULE / ORAL		1328 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
GUAR GUM	GUAR GUM	E89I1637KE	SUSPENSION / ORAL	4.93 mg/5ml		Exact identifier — unii candidate 15 equally ranked IID candidates
FD&C BLUE NO. 2	FD&C BLUE NO. 2	L06K8R7DQK	TABLET, DELAYED RELEASE / ORAL	0.2 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE, EXTENDED RELEASE / ORAL		117 mg	Exact identifier — unii candidate 39 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 / INTRAMUSCULAR		164 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
ACESULFAME POTASSIUM	ACESULFAME POTASSIUM	23OV73Q5G9	POWDER, FOR SUSPENSION / ORAL	45 mg/5ml		Exact identifier — unii candidate 17 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER / ORAL		602 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	POWDER, FOR SUSPENSION / ORAL		7093 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		18 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	PASTILLE / ORAL	NA		Exact identifier — unii candidate 22 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
A090142-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG	TABLET, CHEWABLE / ORAL	2011-08-30
A090142-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, CHEWABLE / ORAL	2011-08-30
A090142-003	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	5MG	TABLET, CHEWABLE / ORAL	2011-08-30
A090142-004	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, CHEWABLE / ORAL	2011-08-30

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 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	A090142-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL	2011-08-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090142-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	2011-08-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090142-003	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET, CHEWABLE / ORAL	2011-08-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090142-004	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET, CHEWABLE / ORAL	2011-08-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090142-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL	2011-08-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090142-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	2011-08-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090142-003	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET, CHEWABLE / ORAL	2011-08-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090142-004	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET, CHEWABLE / ORAL	2011-08-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090142-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL	2011-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090142-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	2011-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090142-003	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET, CHEWABLE / ORAL	2011-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090142-004	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET, CHEWABLE / ORAL	2011-08-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090142-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL	2011-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090142-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	2011-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090142-003	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET, CHEWABLE / ORAL	2011-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090142-004	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET, CHEWABLE / ORAL	2011-08-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090142-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL	2011-08-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090142-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	2011-08-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090142-003	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET, CHEWABLE / ORAL	2011-08-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090142-004	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET, CHEWABLE / ORAL	2011-08-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090142-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL	2011-08-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090142-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	2011-08-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090142-003	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET, CHEWABLE / ORAL	2011-08-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090142-004	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET, CHEWABLE / ORAL	2011-08-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090142-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL	2011-08-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090142-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	2011-08-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090142-003	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET, CHEWABLE / ORAL	2011-08-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090142-004	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET, CHEWABLE / ORAL	2011-08-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090142-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL	2011-08-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090142-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	2011-08-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090142-003	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET, CHEWABLE / ORAL	2011-08-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090142-004	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET, CHEWABLE / ORAL	2011-08-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090142-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL	2011-08-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090142-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	2011-08-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090142-003	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET, CHEWABLE / ORAL	2011-08-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090142-004	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET, CHEWABLE / ORAL	2011-08-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090142-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL	2011-08-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090142-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	2011-08-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090142-003	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET, CHEWABLE / ORAL	2011-08-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090142-004	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET, CHEWABLE / ORAL	2011-08-30	`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
780b12b3-7c49-4f10-8d49-e5aac217273a			54812a5b-ce4a-47ff-a481-0ed36ca17f5d	2024-12-09	Warnings	Exact identifier spl set id: 54812a5b-ce4a-47ff-a481-0ed36ca17f5d

Reported adverse events (FAERS/openFDA)#

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