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allergy relief d

Meijer Distribution, Inc. Allergy Relief-D Drug Facts

Approved
Approval ID

dd19215c-0da7-483a-88e3-6a32ac210c4c

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 28, 2025

Manufacturers
FDA

Meijer Distribution Inc

DUNS: 006959555

Products 1

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

loratadine, Pseudoephedrine sulfate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code41250-954
Application NumberANDA076050
Product Classification
M
Marketing Category
C73584
G
Generic Name
loratadine, Pseudoephedrine sulfate
Product Specifications
Route of AdministrationORAL
Effective DateMay 28, 2025
FDA Product Classification

INGREDIENTS (9)

LORATADINEActive
Quantity: 5 mg in 1 1
Code: 7AJO3BO7QN
Classification: ACTIB
PSEUDOEPHEDRINE SULFATEActive
Quantity: 120 mg in 1 1
Code: Y9DL7QPE6B
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/28/2025

Package/Label Principal Display Panel

meijer®

COMPARE TO CLARITIN-D® 12 HOUR ACTIVE INGREDIENTS

NON-DROWSY*

Allergy Relief-D

Pseudoephedrine Sulfate, 120 mg

Loratadine, 5 mg Extended-Release Tablets

Nasal Decongestant | Antihistamine

12 HOUR

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 & Outdoor Allergies

Allergy & Congestion

*When taken as directed. See Drug Facts Panel.

Actual Size

20 TABLETS

![7u0-6e-allergy-relief-d.jpg](/dailymed/image.cfm?name=7u0-6e-allergy- relief-d.jpg&id=880402)

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 6/15/2018

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: 6/15/2018

Active ingredients (in each tablet)

Loratadine 5 mg

Pseudoephedrine sulfate 120 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 6/15/2018

Purpose

Antihistamine

Nasal decongestant

WARNINGS SECTION

LOINC: 34071-1Updated: 6/15/2018

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 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.

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 right away (1-800-222-1222).

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/28/2025

Directions

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 SAFETY INFORMATION

LOINC: 60561-8Updated: 6/15/2018

Other information

**each tablet contains:** calcium 25 mg

do not use if blister unit is broken or torn

store between 20° to 25°C (68° to 77°F)

keep in a dry place

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 6/15/2018

Inactive ingredients

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

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 6/15/2018

Questions or comments?

1-800-719-9260

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allergy relief d - FDA Drug Approval Details