Allergy relief-D

Manufacturer
EQUATE (WAL-MART STORES, INC.) | Sun Pharmaceutical Industries Limited
Effective date
2019-05-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:59:35

Label at a glance#

ProductAllergy relief-D
Active ingredientCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE
Label structure10 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 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 batch number and expiration date

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each extended-release tablet)Purpose
Cetirizine HCl, USP 5 mgAntihistamine
Pseudoephedrine HCl, USP 120 mgNasal 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 nose or throat
    • nasal congestion
  • reduces swelling of nasal passages
  • temporarily relieves sinus congestion and pressure
  • temporarily restores freer breathing through the nose

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.
  • 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 after 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.

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not break or chew tablet; swallow tablet whole
adults and children 12 years and overtake 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours.
adults 65 years and overask a doctor
children under 12 years of ageask a doctor
consumers with liver or kidney diseaseask 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 batch 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

SPL UNCLASSIFIED SECTION

ammonium hydroxide, iron oxide black, isopropyl alcohol, N-butyl alcohol, propylene glycol, shellac glaze

Questions?

OTC - QUESTIONS SECTION

1-888-287-1915

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY: Walmart Inc.,
Bentonville, AR 72716

PRINCIPAL DISPLAY PANEL - 24 Tablet Blister Pack Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 49035-982-24

equate™

Compare to
Zyrtec-D® 12Hr
active ingredients*

Allergy Relief
Nasal Decongestant

Cetirizine Hydrochloride and Pseudoephedrine
Hydrochloride Extended-release Tablets, USP 5 mg/120 mg
Antihistamine/Nasal Decongestant

INDOOR AND OUTDOOR ALLERGIES

12
HOURS

ALLERGY & CONGESTION

12 Hour Relief of:

  • Sneezing
  • Runny nose
  • Itchy, watery eyes
  • Itchy throat or nose
  • Sinus pressure
  • Nasal congestion

Original prescription strength

Actual Size

24
TABLETS
(4 blister cards of
6 tablets each)

PRINCIPAL DISPLAY PANEL - 24 Tablet Blister Pack Carton
PRINCIPAL DISPLAY PANEL - 24 Tablet Blister Pack Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1014571cetirizine HCl 5 MG / pseudoephedrine HCl 120 MG 12HR Extended Release Oral TabletPSN2
101457112 HR cetirizine hydrochloride 5 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral TabletSCD2
1014571cetirizine dihydrochloride 5 MG / pseudoephedrine HCl 120 MG 12 HR Extended Release Oral TabletSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CETIRIZINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
PSEUDOEPHEDRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49035-982-242021-01-29C16284748780-1ba0f9c33-44ca-a910-e053-dadaa90a0b85Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-982-24Allergy relief-D6 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE62
49035-982-24Allergy relief-D4 in 1 CARTONTABLET, FILM COATED, EXTENDED RE42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-982ALLERGY RELIEF-D (CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [EQUATE (WAL-MART STORES, INC.)]2Legacy NDC, 2 package rows20190531_325975c2-9f88-4500-a620-deb419f1f35c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-982-24EA - Each49035-9822336183e-dd6b-4924-a9b4-1463e68fe2e212023-04-07

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49035-98249035-982-24

Ingredients#

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

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

Source Document#

Source XML

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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-28

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-2884e616aacf4f…
2026-08-18 06:07:402026-07A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-283f01610625f2…
2019-09-15 20:21 UTC2019-09A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-28b00525d2431f…
2019-07-19 19:46 UTC2019-07A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-28f41ea6bd6efb…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ef4fc264-bf2e-404d-95a0-ff92ed0bc347325975c2-9f88-4500-a620-deb419f1f35c2019-05-23WarningsExact identifier
spl id: ef4fc264-bf2e-404d-95a0-ff92ed0bc347
spl set id: 325975c2-9f88-4500-a620-deb419f1f35c

Reported adverse events (FAERS/openFDA)#

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