MedPath

Allergy Relief-D

HEB-Loratadine and Pseudoephedrine sulfate ER tablets

Approved
Approval ID

36230417-8687-d9fd-e063-6394a90ac2e5

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 27, 2025

Manufacturers
FDA

HEB

DUNS: 007924756

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

LORATADINE AND PSEUDOEPHEDRINE SULFATE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code37808-787
Application NumberANDA218017
Product Classification
M
Marketing Category
C73584
G
Generic Name
LORATADINE AND PSEUDOEPHEDRINE SULFATE
Product Specifications
Route of AdministrationORAL
Effective DateMay 27, 2025
FDA Product Classification

INGREDIENTS (12)

PSEUDOEPHEDRINE SULFATEActive
Quantity: 240 mg in 1 1
Code: Y9DL7QPE6B
Classification: ACTIB
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: L11K75P92J
Classification: IACT
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
LORATADINEActive
Quantity: 10 mg in 1 1
Code: 7AJO3BO7QN
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/27/2025

15's carton

ComparetoCLARITIN-D® 24 HOURactive 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 carton

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/27/2025

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 the nose

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/27/2025

Active ingredient (in each capsule)

Loratadine, USP 10 mg

Pseudoephedrine sulfate, USP 240 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/27/2025

Purpose

Antihistamine

Nasal decongestant

WARNINGS SECTION

LOINC: 34071-1Updated: 8/20/2021

Warnings

Do not use

• 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

• 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

do not take more than directed. Taking more than directed may cause drowsiness.

Stop use and ask a doctor if

• 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,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/27/2025

Directions

• 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 SECTION

LOINC: 44425-7Updated: 5/27/2025

Other information

  • 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 INGREDIENT SECTION

LOINC: 51727-6Updated: 5/27/2025

Inactive ingredients

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

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 5/27/2025

Questions or comments?

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

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 5/27/2025

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

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Allergy Relief-D - FDA Drug Approval Details