Childrens Allergy Relief

Manufacturer: L.N.K. International, Inc. | LNK International, Inc.
Effective date: 2020-05-13
Label type: HUMAN OTC DRUG LABEL
Version: 8
Source: legacy-cache
Hydrated at: 2026-08-01 23:30:54

Label at a glance#

ProductChildrens Allergy Relief

Active ingredientCETIRIZINE HYDROCHLORIDE

Label structure9 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

may be taken with or without water 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

Storage and handling

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store between 20°-25°C (68°-77°F) see end flap for expiration date and lot number

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-426-9391

Label contents#

Full prescribing information#

Active ingredient (in each chewable tablet)

OTC - ACTIVE INGREDIENT SECTION

Cetirizine HCl 10 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
alcohol, sedatives, and tranquilizers may increase drowsiness
avoid alcoholic drinks
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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

may be taken with or without water

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

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
store between 20°-25°C (68°-77°F)
see end flap for expiration date and lot number

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, artificial flavors, benzyl alcohol, betadex, colloidal silicon dioxide, dl-alpha-tocopherol, ferric oxide red, ferric oxide yellow, lactose monohydrate, magnesium stearate, maltodextrin, microcrystalline cellulose, propylene glycol, talc, tutti frutti flavor

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

QUALITY
PLUS

NDC 50844-578-02

*Compare to the active ingredient
in Children’s Zyrtec® Allergy

AGES 6+

CHILDREN'S
ALLERGY RELIEF

Cetirizine HCl Chewable 10 mg
Antihistamine

Indoor and Outdoor Allergies

Tutti Frutti
Flavored

12 Chewable Tablets

Actual Size

TAMPER EVIDENT: DO NOT USE IF
PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS
ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by McNeil Consumer
Healthcare, owner of the registered trademark Children’s Zyrtec® Allergy.
50844 ORG031357802 Product of India

Distributed by
LNK INTERNATIONAL, INC.
60 Arkay Drive, Hauppauge, NY 11788
USA

Quality Plus 44-578

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
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	1
BETADEX	INACTIVE INGREDIENT	JV039JZZ3A	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	1
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	1
TOCOPHERYL NICOTINATE, D-.ALPHA.	INACTIVE INGREDIENT	WI1J5UCY5C	1

Products#

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

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

Childrens Allergy Relief
Cetirizine HCl
CETIRIZINE HYDROCHLORIDE
CETIRIZINE
ACESULFAME POTASSIUM
BENZYL ALCOHOL
BETADEX
SILICON DIOXIDE
TOCOPHERYL NICOTINATE, D-.ALPHA.
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MALTODEXTRIN
MICROCRYSTALLINE CELLULOSE
PROPYLENE GLYCOL
TALC

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
50844-578	50844-578-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CETIRIZINE HYDROCHLORIDE	64O047KTOA	ACTIB
ACESULFAME POTASSIUM	23OV73Q5G9	IACT
BENZYL ALCOHOL	LKG8494WBH	IACT
BETADEX	JV039JZZ3A	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
TOCOPHERYL NICOTINATE, D-.ALPHA.	WI1J5UCY5C	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
FERRIC OXIDE YELLOW	EX438O2MRT	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MALTODEXTRIN	7CVR7L4A2D	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
TALC	7SEV7J4R1U	IACT

Source Document#

Source XML · Source PDF

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 · 397 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, COATED / ORAL		16 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE, EXTENDED RELEASE / ORAL		117 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SOLUTION / TOPICAL	2 %w/w		Exact identifier — unii candidate 50 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	TABLET, DELAYED RELEASE / ORAL	2.31 mg		Exact identifier — unii candidate 50 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / INTRAMUSCULAR		7459 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	CREAM / TOPICAL		160 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	OINTMENT / TOPICAL	2.2 %w/w		Exact identifier — unii candidate 50 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	LOTION / TOPICAL		4000 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, ORALLY DISINTEGRATING / ORAL		2 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / DENTAL	2 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER, FOR SUSPENSION / ORAL		120 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / INTRAVENOUS		16624 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, ORALLY DISINTEGRATING / ORAL		1800 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LOTION, AUGMENTED / TOPICAL		2070 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	PASTE / DENTAL	34 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	CAPSULE, DELAYED RELEASE / ORAL		3 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		336 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CREAM / VAGINAL		51 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	PELLET / ORAL		34 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		53 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
ACESULFAME POTASSIUM	ACESULFAME POTASSIUM	23OV73Q5G9	TABLET, ORALLY DISINTEGRATING / ORAL		24 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION / SOFT TISSUE		23 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET / ORAL		4384 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION / SUBCUTANEOUS		90 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FILM COATED / ORAL		91 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SUSPENSION / ORAL		400 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	TABLET / BUCCAL	0.4 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	SYSTEM / INTRAVITREAL	0.02 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET, DELAYED RELEASE / ORAL		2313 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii candidate 81 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
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	LIQUID / INTRAVENOUS	1.04 %w/v		Exact identifier — unii candidate 50 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		144 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	OINTMENT / TOPICAL	74.6 %w/w		Exact identifier — unii candidate 35 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED PELLETS / ORAL		69 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	CAPSULE, EXTENDED RELEASE / ORAL		5364 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET, FILM COATED / ORAL		968 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	SUSPENSION, EXTENDED RELEASE / ORAL		1120 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	LOZENGE / TRANSMUCOSAL		100 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER, FOR SUSPENSION / ORAL		2553 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	GRANULE, FOR SUSPENSION / ORAL	NA		Exact identifier — unii candidate 38 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER / ORAL		25 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
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, SOLUTION / INTRA-ARTICULAR		23 mg	Exact identifier — unii candidate 50 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
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / NASAL		20 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, DELAYED RELEASE / ORAL		36 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		47 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	FILM, SOLUBLE / ORAL		2 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	GRANULE, FOR SUSPENSION / ORAL		296 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER, FOR SOLUTION / ORAL		280 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET, CHEWABLE / ORAL		1412 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	TABLET / ORAL		8 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	LOZENGE / ORAL		50 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	FILM, SOLUBLE / BUCCAL		5 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FOR SUSPENSION / ORAL		24 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	WAFER / ORAL	66 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	TABLET, EXTENDED RELEASE / ORAL		7 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CLOTH / TOPICAL	0.03 mg/mg		Exact identifier — unii candidate 81 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SUSPENSION / TOPICAL	1 %w/w		Exact identifier — unii candidate 50 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 44.

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
A078692-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG	TABLET, CHEWABLE / ORAL			2008-02-14
A078692-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, CHEWABLE / ORAL		RS	2008-02-14

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 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A078692-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL		2008-02-14	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078692-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	RS	2008-02-14	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A078692-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL		2008-02-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078692-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	RS	2008-02-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078692-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL		2008-02-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078692-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	RS	2008-02-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078692-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL		2008-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078692-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	RS	2008-02-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078692-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL		2008-02-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078692-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	RS	2008-02-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078692-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL		2008-02-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078692-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	RS	2008-02-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078692-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL		2008-02-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078692-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	RS	2008-02-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078692-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL		2008-02-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078692-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	RS	2008-02-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078692-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL		2008-02-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078692-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	RS	2008-02-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078692-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL		2008-02-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078692-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	RS	2008-02-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078692-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL		2008-02-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078692-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	RS	2008-02-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078692-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL		2008-02-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078692-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	RS	2008-02-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078692-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL		2008-02-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078692-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	RS	2008-02-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078692-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL		2008-02-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078692-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	RS	2008-02-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078692-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL		2008-02-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078692-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	RS	2008-02-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078692-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL		2008-02-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078692-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	RS	2008-02-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078692-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL		2008-02-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078692-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	RS	2008-02-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078692-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL		2008-02-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078692-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	RS	2008-02-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078692-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL		2008-02-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078692-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	RS	2008-02-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078692-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL		2008-02-14	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078692-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	RS	2008-02-14	`4b0b4de00fa7…`

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
e5c4d1fa-b9b0-4ee1-b6e0-11204e72463d			9f230fa7-fdc9-4b56-aa61-2acc5197ac3a	2021-05-07	Warnings	Exact identifier spl set id: 9f230fa7-fdc9-4b56-aa61-2acc5197ac3a

Reported adverse events (FAERS/openFDA)#

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