Cetirizine Hydrochloride Tablets

Manufacturer: Unichem Pharmaceuticals (USA), Inc.
Effective date: 2018-12-06
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: legacy-cache
Hydrated at: 2026-08-02 00:44:20

Label at a glance#

Productcetirizine hydrochloride

Active ingredientCETIRIZINE HYDROCHLORIDE

Label structure12 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

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 adults and children 6 years and over One 10 mg tablet once daily; do not take more than...

Storage and handling

store between 20° to 25° C (68° to 77° F)

Contacts and useful links#

PhoneLabel contact1-866-562-4616

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS

OTC - ACTIVE INGREDIENT SECTION

(IN EACH TABLET)

For 5 mg

Cetirizine HCl USP 5 mg

For 10 mg

Cetirizine HCl USP 10 mg

OTC - PURPOSE SECTION

Antihistamine

INDICATIONS AND USAGE

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

▪ 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

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 tranquilizers or sedatives.

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 a doctor if

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:

if breast-feeding: not recommended
if pregnant: ask a health professional before use.

OTC - 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.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING

STORAGE AND HANDLING SECTION

store between 20° to 25° C (68° to 77° F)

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone and titanium dioxide

OTC - QUESTIONS

OTC - QUESTIONS SECTION

call 1-866-562-4616

SPL UNCLASSIFIED SECTION

Manufactured by:

UNICHEM LABORATORIES LTD.

Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India

Distributed by:

Company Logo

Rochelle Park, NJ 07662.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cetirizine Hydrochloride Tablets 5 mg-For Hives Relief

Cetirizine Hydrochloride Tablets 10 mg-For Hives Relief

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
CETIRIZINE HYDROCHLORIDE	ACTIVE INGREDIENT	64O047KTOA	1
CETIRIZINE	ACTIVE MOIETY	YO7261ME24	1
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	1
POVIDONE K29/32	INACTIVE INGREDIENT	390RMW2PEQ	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	1

Products#

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

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

cetirizine hydrochloride
CETIRIZINE
HYPROMELLOSE 2910 (5 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 400
POVIDONE, UNSPECIFIED
STARCH, CORN
TITANIUM DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
29300-330	29300-330-13, 29300-330-45, 29300-330-75, 29300-330-19, 29300-330-01, 29300-330-99, 29300-330-00
29300-340	29300-340-13, 29300-340-45, 29300-340-75, 29300-340-19, 29300-340-01, 29300-340-99, 29300-340-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CETIRIZINE HYDROCHLORIDE	64O047KTOA	ACTIB
HYPROMELLOSE 2910 (5 MPA.S)	R75537T0T4	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
POVIDONE, UNSPECIFIED	FZ989GH94E	IACT
STARCH, CORN	O8232NY3SJ	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
CETIRIZINE HYDROCHLORIDE	64O047KTOA	ACTIB
HYPROMELLOSE 2910 (5 MPA.S)	R75537T0T4	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
POVIDONE, UNSPECIFIED	FZ989GH94E	IACT
STARCH, CORN	O8232NY3SJ	IACT
TITANIUM DIOXIDE	15FIX9V2JP	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 4 · 198 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
HYPROMELLOSE 2910 (5 MPA.S)	HYPROMELLOSE 2910 (5 MPA.S)	R75537T0T4	TABLET / BUCCAL		5 mg	Exact identifier — unii candidate 23 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	GRANULE / ORAL		8946 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET, DELAYED RELEASE / ORAL		2313 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	FILM, SOLUBLE / ORAL		29 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	IMPLANT / INTRAVITREAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, COATED / ORAL		184 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	INSERT / VAGINAL		2282 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	INHALANT / ORAL	0.08 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	GEL / VAGINAL		1250 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / SUBLINGUAL	17.5 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	SYSTEM / INTRAVITREAL	0.02 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	GRANULE, FOR SUSPENSION / ORAL		14 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	INJECTION, SOLUTION / INTRAVENOUS		24186 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	POWDER / ORAL		50 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SPONGE / TOPICAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET, ORALLY DISINTEGRATING / ORAL		366 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CAPSULE, EXTENDED RELEASE / ORAL		17 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL		980 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	POWDER / RESPIRATORY (INHALATION)		25 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	750 mg		Exact identifier — unii candidate 38 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	IMPLANT / SUBCUTANEOUS	0.5 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
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, EXTENDED RELEASE / ORAL		67 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	FILM, SOLUBLE / ORAL		2 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SOLUTION / OPHTHALMIC		46 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	EMULSION / TOPICAL	1.2 %w/w		Exact identifier — unii candidate 36 equally ranked IID candidates
HYPROMELLOSE 2910 (5 MPA.S)	HYPROMELLOSE 2910 (5 MPA.S)	R75537T0T4	TABLET, EXTENDED RELEASE / ORAL		670 mg	Exact identifier — unii candidate 23 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET / SUBLINGUAL		505 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET, CHEWABLE / ORAL		1412 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	INHALANT / ORAL	NA		Exact identifier — unii candidate 38 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	SUSPENSION, EXTENDED RELEASE / ORAL		71 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, EXTENDED RELEASE / ORAL		90 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, COATED / ORAL		256 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET / ORAL		4384 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SHAMPOO, SUSPENSION / TOPICAL	3 %w/v		Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	POWDER, FOR SUSPENSION / ORAL		297 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER, FOR SUSPENSION / ORAL		120 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SUPPOSITORY, EXTENDED RELEASE / INTRAUTERINE	1 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS	107 mg		Exact identifier — unii candidate 38 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE PELLETS / ORAL		24 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	INJECTION / INTRAVENOUS	900 mg		Exact identifier — unii candidate 38 equally ranked IID candidates
HYPROMELLOSE 2910 (5 MPA.S)	HYPROMELLOSE 2910 (5 MPA.S)	R75537T0T4	CAPSULE, DELAYED RELEASE / ORAL		563 mg	Exact identifier — unii candidate 23 equally ranked IID candidates
HYPROMELLOSE 2910 (5 MPA.S)	HYPROMELLOSE 2910 (5 MPA.S)	R75537T0T4	TABLET, FILM COATED / ORAL		264 mg	Exact identifier — unii candidate 23 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		11 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	CAPSULE, DELAYED RELEASE / ORAL		2087 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CONCENTRATE / ORAL		3000 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
HYPROMELLOSE 2910 (5 MPA.S)	HYPROMELLOSE 2910 (5 MPA.S)	R75537T0T4	FILM / SUBLINGUAL	4.68 mg		Exact identifier — unii candidate 23 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, LIQUID FILLED / ORAL		12 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CAPSULE, DELAYED RELEASE / ORAL		216 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS		214 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	CAPSULE / ORAL		3990 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
HYPROMELLOSE 2910 (5 MPA.S)	HYPROMELLOSE 2910 (5 MPA.S)	R75537T0T4	SPRAY / NASAL	1 mg/1ml		Exact identifier — unii candidate 23 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED PELLETS / ORAL	4.4 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
HYPROMELLOSE 2910 (5 MPA.S)	HYPROMELLOSE 2910 (5 MPA.S)	R75537T0T4	TABLET, DELAYED RELEASE / ORAL		103 mg	Exact identifier — unii candidate 23 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SUSPENSION / ORAL		400 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		9 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 40 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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A078680-001	CETIRIZINE HYDROCHLORIDE HIVES	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL	2009-06-26
A078680-002	CETIRIZINE HYDROCHLORIDE HIVES	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2009-06-26
A078680-003	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL	2009-06-26
A078680-004	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2009-06-26

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 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A078680-001	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2009-06-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078680-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2009-06-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078680-003	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2009-06-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078680-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2009-06-26	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A078680-001	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2009-06-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078680-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2009-06-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078680-003	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2009-06-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078680-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2009-06-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078680-001	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2009-06-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078680-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2009-06-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078680-003	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2009-06-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078680-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2009-06-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078680-001	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2009-06-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078680-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2009-06-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078680-003	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2009-06-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078680-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2009-06-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078680-001	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2009-06-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078680-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2009-06-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078680-003	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2009-06-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078680-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2009-06-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078680-001	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2009-06-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078680-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2009-06-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078680-003	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2009-06-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078680-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2009-06-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078680-001	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2009-06-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078680-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2009-06-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078680-003	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2009-06-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078680-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2009-06-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078680-001	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2009-06-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078680-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2009-06-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078680-003	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2009-06-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078680-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2009-06-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078680-001	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2009-06-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078680-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2009-06-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078680-003	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2009-06-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078680-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2009-06-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078680-001	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2009-06-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078680-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2009-06-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078680-003	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2009-06-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078680-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2009-06-26	`2680178bc6a6…`

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
d0cda4dc-2275-4366-bbc7-d3bc4c09bdd9			a72b3687-8940-448b-a60f-2388f906a2b7	2018-12-06	Warnings	Exact identifier spl id: d0cda4dc-2275-4366-bbc7-d3bc4c09bdd9 spl set id: a72b3687-8940-448b-a60f-2388f906a2b7

Reported adverse events (FAERS/openFDA)#

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