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non drowsy allergy relief

Meijer Distribution, Inc. Non-Drowsy Allergy Relief Drug Facts

Approved
Approval ID

4762c96e-d562-4f74-a275-8cba597987f9

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 8, 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

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code41250-890
Application NumberANDA076011
Product Classification
M
Marketing Category
C73584
G
Generic Name
loratadine
Product Specifications
Route of AdministrationORAL
Effective DateMay 8, 2025
FDA Product Classification

INGREDIENTS (8)

LORATADINEActive
Quantity: 10 mg in 1 1
Code: 7AJO3BO7QN
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/8/2025

Package/Label Principal Display Panel

meijer®

COMPARE TO CLARITIN® REDITABS® ACTIVE INGREDIENT

NON-DROWSY

Allergy Relief

Loratadine Orally Disintegrating Tablets, 10 mg | Antihistamine

Indoor & Outdoor Allergies

24 HOUR

RELIEF OF: SNEEZING; RUNNY NOSE; ITCHY, WATERY EYES; ITCHY THROAT OR NOSE

Melts In Your Mouth

No Water Needed

30 ORALLY DISINTEGRATING TABLETS

Original Prescription Strength

*When taken as directed. See Drug Facts Panel.

Actual Size

30 ORALLY DISINTEGRATING TABLETS

![5v9-6e-allergy-relief.jpg](/dailymed/image.cfm?name=5v9-6e-allergy- relief.jpg&id=874779)

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/14/2020

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

runny nose

itchy, watery eyes

sneezing

itching of the nose or throat

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/14/2020

Active ingredient (in each tablet)

Loratadine 10 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/14/2020

Purpose

Antihistamine

WARNINGS SECTION

LOINC: 34071-1Updated: 5/14/2020

Warnings

Do not use

if you have ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before use if you have

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.

If pregnant or breast-feeding,

ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 5/14/2020

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: 5/8/2025

Directions

place 1 tablet on tongue; tablet disintegrates, with or without water  

adults and children 6 years and over

1 tablet daily; not more than 1 tablet in 24 hours

children under 6 years of age

ask a doctor

consumers with liver or kidney disease

ask a doctor

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 5/8/2025

Other information

**do not use if printed blister unit is broken or torn**

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

use tablet immediately after opening individual blister

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/14/2020

Inactive ingredients

croscarmellose sodium, crospovidone, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, natural and artificial mint flavor, sucralose

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 5/8/2025

Questions or comments?

1-800-719-9260

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