Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride

Manufacturer: Sun Pharmaceutical Industries, Inc. | Sun Pharmaceutical Industries Limited
Effective date: 2024-11-27
Label type: Human OTC Drug Label
Version: 11
Source: full-release
Hydrated at: 2026-06-01 00:39:41

Label at a glance#

ProductCetirizine Hydrochloride and Pseudoephedrine Hydrochloride

Active ingredientCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE

Label structure16 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 nasal congestion reduces swelling of nasal passages temporarily relieves sinus congestion and pressure temporarily restores freer breathing through the nose

Dosage and administration

do not break or chew tablet; swallow tablet whole adults and children 12 years and over take 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours. adults 65 years and over ask a doctor children under 12 years of age ask a doctor consumers with liver or kidney disease ask a doctor

Storage and handling

store between 20° to 25°C (68° to 77°F) Do not use if carton is opened or if the blister unit is broken See side panel 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 ingredients

OTC - ACTIVE INGREDIENT SECTION

Cetirizine HCl, USP 5 mg
Pseudoephedrine HCl, USP 120 mg

Purposes

OTC - PURPOSE SECTION

Antihistamine
Nasal decongestant

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
- nasal congestion
reduces swelling of nasal passages
temporarily relieves sinus congestion and pressure
temporarily restores freer breathing through the nose

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.
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (cer tain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks af ter stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

heart disease
thyroid disease
diabetes
glaucoma
high blood pressure
trouble urinating due to an enlarged prostate gland
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

do not use more than directed
drowsiness may occur
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

OTC - STOP USE SECTION

an allergic reaction to this product occurs. Seek medical help right away.
you get nervous, dizzy, or sleepless
symptoms do not improve within 7 days or are accompanied by fever

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

do not break or chew tablet; swallow tablet whole

adults and children 12 years and over	take 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours.
adults 65 years and over	ask a doctor
children under 12 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 carton is opened or if the blister unit is broken
See side panel for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

hydroxyethyl cellulose, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, stearic acid, titanium dioxide
Imprinting Ink Contents: ammonium hydroxide, iron oxide black, isopropyl alcohol, N-butyl alcohol, propylene glycol, shellac glaze

Questions?

OTC - QUESTIONS SECTION

Call toll free 1-800-818-4555 weekdays

Principal Display Panel - Showbox

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 62756-915-62

Original Prescription Strength
Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended-release Tablets, USP
5 mg/120 mg
Antihistamine/Nasal Decongestant
Indoor & Outdoor Allergies
ALLERGY & SINUS
SUN PHARMA
Actual Size
DO NOT USE IF INDIVIDUAL BLISTER UNIT IS OPEN OR TORN
12 Tablets (2 blister cards of 6 tablets each)

Principal Display Panel - Blister pack

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablet, USP

5 mg/120 mg

Mfg. by: Sun Pharmaceutical Ind. Ltd. India.

spl-cetirizine-pseudoephedrine-blister

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1014571	cetirizine HCl 5 MG / pseudoephedrine HCl 120 MG 12HR Extended Release Oral Tablet	PSN	11
1014571	12 HR cetirizine hydrochloride 5 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral Tablet	SCD	11
1014571	cetirizine dihydrochloride 5 MG / pseudoephedrine HCl 120 MG 12 HR Extended Release Oral Tablet	SY	11

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
CETIRIZINE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813
PSEUDOEPHEDRINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35be	Product name	1	20200304
a255659f-db40-429d-8c07-5f173f330d9c	Product name	1	20190402
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
e974e22d-8688-7d92-1e87-40c1079e170c	Product name	3	20151125
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
30c51294-7ae9-8007-7de6-58222684a0be	Product name	1	20140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66	Product name	1	20140508
70a83adc-6047-bbea-5a08-dfd304aa47d2	Product name	1	20140508
858ce051-9941-aafc-8c7c-44a8e0227463	Product name	1	20140508
b893258d-0942-3d8a-3411-056ea0788ff5	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
62756-915-60	Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride	6 in 1 BLISTER PACK	TABLET, FILM COATED, EXTENDED RE	6	11
62756-915-62	Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride	2 in 1 CARTON	TABLET, FILM COATED, EXTENDED RE	2	11
62756-915-73	Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride	4 in 1 CARTON	TABLET, FILM COATED, EXTENDED RE	4	11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62756-915	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.]	11	Current NDC, Legacy NDC, 3 package rows	20241129_796c4b81-145b-4050-a851-dec81ff97006.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
CETIRIZINE HYDROCHLORIDE	ACTIVE INGREDIENT	64O047KTOA	5
PSEUDOEPHEDRINE HYDROCHLORIDE	ACTIVE INGREDIENT	6V9V2RYJ8N	5
CETIRIZINE	ACTIVE MOIETY	YO7261ME24	5
PSEUDOEPHEDRINE	ACTIVE MOIETY	7CUC9DDI9F	5
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	5
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	5
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	5
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	5
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	5
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	5
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	5
SHELLAC	INACTIVE INGREDIENT	46N107B71O	5
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	5

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride
CETIRIZINE HYDROCHLORIDE
CETIRIZINE
PSEUDOEPHEDRINE HYDROCHLORIDE
PSEUDOEPHEDRINE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYDROXYETHYL CELLULOSE, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
STEARIC ACID
TITANIUM DIOXIDE
AMMONIA
FERROSOFERRIC OXIDE
ISOPROPYL ALCOHOL
BUTYL ALCOHOL
PROPYLENE GLYCOL
SHELLAC

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
62756-915	62756-915-60, 62756-915-62, 62756-915-73

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CETIRIZINE HYDROCHLORIDE	64O047KTOA	ACTIB
PSEUDOEPHEDRINE HYDROCHLORIDE	6V9V2RYJ8N	ACTIB
HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	IACT
HYDROXYETHYL CELLULOSE, UNSPECIFIED	T4V6TWG28D	IACT
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
STEARIC ACID	4ELV7Z65AP	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
AMMONIA	5138Q19F1X	IACT
FERROSOFERRIC OXIDE	XM0M87F357	IACT
ISOPROPYL ALCOHOL	ND2M416302	IACT
BUTYL ALCOHOL	8PJ61P6TS3	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SHELLAC	46N107B71O	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 3 · 180 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
AMMONIA	AMMONIA SOLUTION	5138Q19F1X	CAPSULE, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii+route 28 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	TABLET, FILM COATED / ORAL	4.4 mg		Exact identifier — unii+route 48 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	TABLET / ORAL		112 mg	Exact identifier — unii+route 48 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		19 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	POWDER, FOR SUSPENSION / ORAL	NA		Exact identifier — unii+route 40 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	TABLET, DELAYED RELEASE / ORAL		6 mg	Exact identifier — unii+route 40 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE (TYPE H)	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	187.6 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	POWDER, FOR SUSPENSION / ORAL	NA		Exact identifier — unii+route 40 equally ranked IID candidates
BUTYL ALCOHOL	BUTYL ALCOHOL	8PJ61P6TS3	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 32 equally ranked IID candidates
AMMONIA	AMMONIA SOLUTION	5138Q19F1X	CAPSULE, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii+route 28 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	TABLET, FILM COATED / ORAL	4.4 mg		Exact identifier — unii+route 48 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE (TYPE H)	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	187.6 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
AMMONIA	AMMONIA SOLUTION	5138Q19F1X	SUSPENSION / ORAL	NA		Exact identifier — unii+route 28 equally ranked IID candidates
BUTYL ALCOHOL	BUTYL ALCOHOL	8PJ61P6TS3	TABLET, DELAYED RELEASE / ORAL	0.05 mg		Exact identifier — unii+route 32 equally ranked IID candidates
AMMONIA	AMMONIA SOLUTION	5138Q19F1X	TABLET / ORAL	NA		Exact identifier — unii+route 28 equally ranked IID candidates
AMMONIA	AMMONIA SOLUTION	5138Q19F1X	CAPSULE, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 28 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	TABLET, FILM COATED / ORAL	0.2 mg		Exact identifier — unii+route 40 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	CAPSULE / ORAL	34.48 mg		Exact identifier — unii+route 48 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	TABLET, DELAYED RELEASE / ORAL		6 mg	Exact identifier — unii+route 40 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	TABLET, COATED / ORAL	NA		Exact identifier — unii+route 40 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	TABLET, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 4 equally ranked IID candidates
BUTYL ALCOHOL	BUTYL ALCOHOL	8PJ61P6TS3	CAPSULE / ORAL	0.02 mg		Exact identifier — unii+route 32 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	CAPSULE, DELAYED RELEASE / ORAL		1 mg	Exact identifier — unii+route 48 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	CAPSULE, COATED / ORAL	0.11 mg		Exact identifier — unii+route 40 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	CAPSULE, COATED PELLETS / ORAL	29 mg		Exact identifier — unii+route 48 equally ranked IID candidates
BUTYL ALCOHOL	BUTYL ALCOHOL	8PJ61P6TS3	CAPSULE, EXTENDED RELEASE / ORAL	0.01 mg		Exact identifier — unii+route 32 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	TABLET / ORAL		112 mg	Exact identifier — unii+route 48 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii+route 48 equally ranked IID candidates
AMMONIA	AMMONIA SOLUTION	5138Q19F1X	TABLET / ORAL	NA		Exact identifier — unii+route 28 equally ranked IID candidates
AMMONIA	AMMONIA SOLUTION	5138Q19F1X	TABLET / ORAL	NA		Exact identifier — unii+route 28 equally ranked IID candidates
AMMONIA	AMMONIA SOLUTION	5138Q19F1X	TABLET, DELAYED RELEASE / ORAL	NA		Exact identifier — unii+route 28 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	CAPSULE / ORAL		11 mg	Exact identifier — unii+route 40 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	TABLET / ORAL		112 mg	Exact identifier — unii+route 48 equally ranked IID candidates
AMMONIA	AMMONIA SOLUTION	5138Q19F1X	SUSPENSION / ORAL	NA		Exact identifier — unii+route 28 equally ranked IID candidates
BUTYL ALCOHOL	BUTYL ALCOHOL	8PJ61P6TS3	TABLET, COATED / ORAL	NA		Exact identifier — unii+route 32 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		615 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
AMMONIA	AMMONIA SOLUTION	5138Q19F1X	SUSPENSION / ORAL	NA		Exact identifier — unii+route 28 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		120 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
BUTYL ALCOHOL	BUTYL ALCOHOL	8PJ61P6TS3	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 32 equally ranked IID candidates
BUTYL ALCOHOL	BUTYL ALCOHOL	8PJ61P6TS3	CAPSULE, EXTENDED RELEASE / ORAL	0.01 mg		Exact identifier — unii+route 32 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	TABLET / ORAL		2 mg	Exact identifier — unii+route 40 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	CAPSULE, EXTENDED RELEASE / ORAL	75.01 mg		Exact identifier — unii+route 48 equally ranked IID candidates
AMMONIA	AMMONIA SOLUTION	5138Q19F1X	TABLET, EXTENDED RELEASE / ORAL		6 mg	Exact identifier — unii+route 28 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	TABLET, DELAYED RELEASE / ORAL		8 mg	Exact identifier — unii+route 48 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	TABLET, DELAYED RELEASE / ORAL		8 mg	Exact identifier — unii+route 48 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	TABLET, EXTENDED RELEASE / ORAL	213.24 mg		Exact identifier — unii+route 48 equally ranked IID candidates
AMMONIA	AMMONIA SOLUTION	5138Q19F1X	TABLET, DELAYED RELEASE / ORAL	NA		Exact identifier — unii+route 28 equally ranked IID candidates
BUTYL ALCOHOL	BUTYL ALCOHOL	8PJ61P6TS3	TABLET, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 32 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		120 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE (TYPE H)	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	187.6 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		11 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	CAPSULE, EXTENDED RELEASE / ORAL	75.01 mg		Exact identifier — unii+route 48 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE (TYPE H)	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	187.6 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
AMMONIA	AMMONIA SOLUTION	5138Q19F1X	CAPSULE / ORAL	0.01 mg		Exact identifier — unii+route 28 equally ranked IID candidates
BUTYL ALCOHOL	BUTYL ALCOHOL	8PJ61P6TS3	TABLET / ORAL	0.01 mg		Exact identifier — unii+route 32 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	CAPSULE, COATED / ORAL	0.11 mg		Exact identifier — unii+route 40 equally ranked IID candidates
BUTYL ALCOHOL	BUTYL ALCOHOL	8PJ61P6TS3	CAPSULE, DELAYED RELEASE / ORAL	NA		Exact identifier — unii+route 32 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		11 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
AMMONIA	AMMONIA SOLUTION	5138Q19F1X	CAPSULE / ORAL	0.01 mg		Exact identifier — unii+route 28 equally ranked IID candidates
BUTYL ALCOHOL	BUTYL ALCOHOL	8PJ61P6TS3	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 32 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090922-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL			2012-09-28

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 2 · 44 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	A090922-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2012-09-28	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A090922-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2012-09-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090922-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2012-09-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090922-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2012-09-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090922-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2012-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090922-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2012-09-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090922-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2012-09-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090922-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2012-09-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090922-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2012-09-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090922-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2012-09-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090922-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2012-09-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090922-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2012-09-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090922-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2012-09-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090922-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2012-09-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090922-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2012-09-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090922-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2012-09-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090922-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2012-09-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090922-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2012-09-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090922-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2012-09-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090922-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2012-09-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090922-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2012-09-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090922-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2012-09-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090922-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2012-09-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090922-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2012-09-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090922-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2012-09-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090922-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2012-09-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090922-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2012-09-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090922-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2012-09-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090922-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2012-09-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090922-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2012-09-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090922-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2012-09-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090922-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2012-09-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090922-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2012-09-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090922-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2012-09-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090922-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2012-09-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090922-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2012-09-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090922-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2012-09-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090922-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2012-09-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090922-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2012-09-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090922-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2012-09-28	`3a93d1ddd44b…`

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
Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	796c4b81-145b-4050-a851-dec81ff97006	2024-11-27	Warnings	Exact identifier ndc (package): 62756-915-60 ndc (package): 62756-915-62 ndc (package): 62756-915-73 ndc (product): 62756-915 ndc11 (package): 62756091562 ndc11 (package): 62756091560 ndc11 (package): 62756091573 spl id: a0bd1e9b-eb9f-46e7-8cee-10bde092d7cb spl set id: 796c4b81-145b-4050-a851-dec81ff97006

Reported adverse events (FAERS/openFDA)#

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