allergy relief d

Manufacturer
Publix Super Markets Inc
Effective date
2020-10-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:34:08

Label at a glance#

Productallergy relief d
Active ingredientLORATADINE, PSEUDOEPHEDRINE SULFATE
Label structure8 sections

Indications and uses

• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • sneezing • itchy, watery eyes • runny nose • itching of the nose or throat • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies • reduces swelling of nasal passages • temporarily relieves sinus congestion and pressure • temporarily restores freer breathing through...

Dosage and administration

• do not divide, crush, chew or dissolve the tablet adults and children 12 years and over 1 tablet every 12 hours; not more than 2 tablets in 24 hours children under 12 years of age ask a doctor consumers with liver or kidney disease ask a doctor

Label contents#

Full prescribing information#

Active ingredients (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Loratadine 5 mg

Pseudoephedrine sulfate 120 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • sneezing
  • itchy, watery eyes
  • runny nose
  • itching of the nose or throat
  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • 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
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain 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
  • high blood pressure
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • liver or kidney disease. Your doctor should determine if you need a different dose.

When using this product do not take more than directed.

OTC - WHEN USING SECTION

Taking more than directed may cause drowsiness.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • an allergic reaction to this product occurs. Seek medical help right away.
  • symptoms do not improve within 7 days or are accompanied by a fever
  • nervousness, dizziness or sleeplessness occurs

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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 divide, crush, chew or dissolve the tablet

adults and children 12 years and over

1 tablet every 12 hours; not more than 2 tablets in 24 hours

children under 12 years of age

ask a doctor

consumers with liver or kidney disease

ask a doctor

Other information

OTHER SAFETY INFORMATION

  • each tablet contains: calcium 25 mg
  • do not use if blister unit is broken or torn
  • store between 68° to 77°F (20° to 25°C)
  • keep in a dry place

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, dibasic calcium phosphate, hypromellose, lactose monohydrate, magnesium stearate, pharmaceutical ink, povidone, titanium dioxide

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

12-HOUR – NON-DROWSY*

allergy relief D

PSEUDOEPHEDRINE SULFATE 120 mg/LORATADINE 5 mg

EXTENDED RELEASE TABLETS

NASAL DECONGESTANT/ANTIHISTIME

ALLERGY & CONGESTION

Relief of:

Nasal and sinus congestion due to colds or allergies

Sneezing - Runny nose - Itchy, watery eyes

Itchy throat or nose due to allergies

INDOOR AND OUTDOOR ALLERGIES

10 EXTENDED RELEASE TABLETS

ACTUAL SIZE

*When taken as directed. See Drug Facts Panel.

Compare to Claritin-D® 12 hour Extended Release Tablets active ingredients

allergy relief d image
allergy relief d image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1242399pseudoephedrine sulfate 120 MG / loratadine 5 MG 12HR Extended Release Oral TabletPSN3
124239912 HR loratadine 5 MG / pseudoephedrine sulfate 120 MG Extended Release Oral TabletSCD3
1242399loratadine 5 MG / pseudoephedrine sulfate 120 MG 12 HR Extended Release Oral TabletSY3

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
56062-555-46allergy relief d1 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE13
56062-555-46allergy relief d10 in 1 CARTONTABLET, FILM COATED, EXTENDED RE103
56062-555-60allergy relief d1 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE13
56062-555-60allergy relief d20 in 1 CARTONTABLET, FILM COATED, EXTENDED RE203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
56062-555ALLERGY RELIEF D (LORATADINE, PSEUDOEPHEDRINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [PUBLIX SUPER MARKETS INC]3Current NDC, Legacy NDC, 4 package rows20201124_8209d7d5-4ecc-4170-ba50-5917bd8c46d4.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
56062-55556062-555-46, 56062-555-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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 44.

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
A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATELORATADINE; PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-30

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-30c2088c7a36db…
2026-09-14 22:38:342026-08A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-3084e616aacf4f…
2026-08-18 06:07:402026-07A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-3087673890dc5c…
2021-03-12 10:30 UTC2021-03A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-303f01610625f2…
2019-09-15 20:21 UTC2019-09A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-30b00525d2431f…
2019-07-19 19:46 UTC2019-07A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-303f0d92c62455…
2023-05-13 08:27 UTC2023-05A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-30053a50430f4f…
2023-01-26 05:58 UTC2023-01A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-303a93d1ddd44b…

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
allergy relief dLORATADINE, PSEUDOEPHEDRINE SULFATEPublix Super Markets Inc8209d7d5-4ecc-4170-ba50-5917bd8c46d42020-10-19WarningsExact identifier
ndc (package): 56062-555-60
ndc (package): 56062-555-46
ndc (product): 56062-555
ndc11 (package): 56062055546
ndc11 (package): 56062055560
spl id: 80e35c89-92c7-4256-8129-4e727f864e03
spl set id: 8209d7d5-4ecc-4170-ba50-5917bd8c46d4

Reported adverse events (FAERS/openFDA)#

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