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First Aid Direct Allergy Relief

First Aid Direct Allergy Relief

Approved
Approval ID

6b43e5a5-30a8-46ca-a44d-1e1abf567b51

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 23, 2025

Manufacturers
FDA

Cintas Corporation

DUNS: 056481716

Products 1

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

Loratadine Tablets

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code42961-120
Application NumberANDA210722
Product Classification
M
Marketing Category
C73584
G
Generic Name
Loratadine Tablets
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 23, 2025
FDA Product Classification

INGREDIENTS (5)

LORATADINEActive
Quantity: 10 mg in 1 1
Code: 7AJO3BO7QN
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/23/2025

Principal Display Panel

Original Prescription Strength

Non-Drowsy*

Allergy Relief

Loratadine Tablets, 10 mg - Antihistamine

Indoor & Outdoor Allergies

†Compare to active ingredient of Claritin®

Relief of:

  • sneezing
  • runny nose
  • itchy, watery eyes
  • itchy throat or nose

24 Hour

Actual Size

20 TABLETS

*When taken as directed. See drug facts panel

Box

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/24/2022

Uses

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

  • runny nose
  • itchy, watery eyes
  • sneezing
  • iching of the nose or throat

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/23/2025

Active Ingredient (in each tablet)

Loratadine 10 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/24/2022

Purpose

Antihistamine

WARNINGS SECTION

LOINC: 34071-1Updated: 8/24/2022

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

Keep out of reach of children.

In case of accidental overdose, contact a doctor or Poison Control Center immediately.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/24/2022

Directions

** 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

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 8/24/2022

Other information

  • store between 20°C to 25°C (68° to 77°F)
  • protect from excessive moisture
  • do not use if blister unit is torn or open

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/24/2022

Inactive ingredients

lactose monohydrate, magensium stearate, pregelatinized starch, sodium startch glycolate

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 8/24/2022

Questions?

1-800-327-2704 Monday - Friday 8:00am - 5:00pm (CDT)

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First Aid Direct Allergy Relief - FDA Drug Approval Details