HEB-Loratadine and Pseudoephedrine sulfate ER tablets

Manufacturer
HEB | Bionpharma Inc. | RECIPHARM PHARMASERVICES PRIVATE LIMITED
Effective date
2025-05-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:01:36

Label at a glance#

ProductAllergy Relief-D
Active ingredientPSEUDOEPHEDRINE SULFATE, LORATADINE
Label structure10 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 daily with a full glass of water; not more than 1 tablet in 24 hours children under 12 years of age ask a doctor consumers with liver or kidney disease ask a doctor

Storage and handling

Safety sealed: do not use if individual blister unit is open or torn store between 20° to 25°C (68° to 77°F) protect from light and store in a dry place

Label contents#

Full prescribing information#

Active ingredient (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

Loratadine, USP 10 mg

Pseudoephedrine sulfate, USP 240 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 enlarged prostrate gland

• liver or kidney disease. Your doctor should determine if you need a different dose.

When using this product

OTC - WHEN USING SECTION

do not take more than directed. 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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• do not divide, crush, chew or dissolve the tablet

adults and children 12 years and over

1 tablet daily with a full glass of water; not more than 1 tablet in 24 hours

children under 12 years of age

ask a doctor

consumers with liver or kidney disease

ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • Safety sealed: do not use if individual blister unit is open or torn
  • store between 20° to 25°C (68° to 77°F)
  • protect from light and store in a dry place

Inactive ingredients

INACTIVE INGREDIENT SECTION

black iron oxide, colloidal silicon dioxide, dibasic calcium phosphate anhydrous, ethyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, povidone, propylene glycol, shellac

Questions or comments?

OTC - QUESTIONS SECTION

call toll free 1-888-235-2466 (Mon - Fri 9AM - 5PM EST)

SPL UNCLASSIFIED SECTION

KEEP OUTER CARTON FOR COMPLETE

WARNINGS AND PRODUCT INFORMATION

THIS PRODUCT IS PACKAGED IN A CHILD-RESITANT AND TAMPER EVIDENT PACKAGE.

Do not use if individual blister unit is open or torn.

†This product is not manufactured or distributed by the

owners of Claritin-D® 24 hour

MADE WITH PRIDE AND CARE FOR

H-E-B® , SAN ANTONIO, TX 78204

100%

GUARANTEE

promise

If you aren't completely pleased

with this product, we'll be happy to

replace it or refund your money.

You have our word on it.

PRODUCT OF INDIA

L0000918-R1024

KD/DRUGS/KTK/25/460/2001

15's carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to CLARITIN-D® 24 HOUR active ingredients ƚ

NDC 37808-787-35

H.E.B

Allergy Relief-D

Loratadine and Pseudoephedrine Sulfate

Exrended-Release Tablets 10 mg/ 240 mg

Indoor & Outdoor Allergies

24

Hour

Non-Drowsy*

Antihistamine/Nasal Decongestant

Original Prescription Strength

15 days of Relief

Relief of:

• Nasal and Sinus Congestion Due to Colds or Allergies

• Sneexing • Runny Nose • Itchy, Watery Eyes

• Itchy Throat or Nose Due to Allergies

15 EXTENDED- RELEASE TABLETS

30's carton30's carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1117562pseudoephedrine sulfate 240 MG / loratadine 10 MG 24HR Extended Release Oral TabletPSN1
111756224 HR loratadine 10 MG / pseudoephedrine sulfate 240 MG Extended Release Oral TabletSCD1
1117562loratadine 10 MG / pseudoephedrine sulfate 240 MG 24 HR Extended Release Oral TabletSY1

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
37808-787-07Allergy Relief-D5 in 1 BLISTER PACKTABLET, EXTENDED RELEASE51
37808-787-07Allergy Relief-D2 in 1 CARTONTABLET, EXTENDED RELEASE21
37808-787-35Allergy Relief-D3 in 1 CARTONTABLET, EXTENDED RELEASE31
37808-787-35Allergy Relief-D5 in 1 BLISTER PACKTABLET, EXTENDED RELEASE51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-787ALLERGY RELIEF-D (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [HEB]1Current NDC, 4 package rows20250529_36230417-8687-d9fd-e063-6394a90ac2e5.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37808-78737808-787-07, 37808-787-35

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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
A218017-001LORATADINE AND PSEUDOEPHEDRINE SULFATELORATADINE; PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2024-05-14

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A218017-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2024-05-1484e616aacf4f…
2026-08-18 06:07:402026-07A218017-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2024-05-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A218017-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2024-05-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218017-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2024-05-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A218017-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2024-05-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218017-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2024-05-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218017-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2024-05-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218017-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2024-05-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218017-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2024-05-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218017-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2024-05-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218017-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2024-05-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A218017-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2024-05-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A218017-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2024-05-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A218017-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2024-05-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A218017-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2024-05-141e350fbaab3a…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218017-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2024-05-14a50c72e98297…

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 AND PSEUDOEPHEDRINE SULFATEHEB36230417-8687-d9fd-e063-6394a90ac2e52025-05-27WarningsExact identifier
ndc (package): 37808-787-07
ndc (package): 37808-787-35
ndc (product): 37808-787
ndc11 (package): 37808078707
ndc11 (package): 37808078735
spl id: 36230417-8688-d9fd-e063-6394a90ac2e5
spl set id: 36230417-8687-d9fd-e063-6394a90ac2e5

Reported adverse events (FAERS/openFDA)#

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