MedPath

Loratadine

Loratadine Tablets USP 10 mg

Approved
Approval ID

3937f769-e8e2-4b32-8338-21b0a74a8697

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 13, 2025

Manufacturers
FDA

CVS Pharmacy, Inc.

DUNS: 062312574

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 Code69842-242
Application NumberANDA208314
Product Classification
M
Marketing Category
C73584
G
Generic Name
Loratadine
Product Specifications
Route of AdministrationORAL
Effective DateMay 13, 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 A POTATOInactive
Code: 5856J3G2A2
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/13/2025

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg Blister Carton (30 Tablets)

CVS Health

Compare to the active
** ingredient in Claritin******®Tablets****
Indoor & Outdoor Allergies
NDC 69842-242-91
** Non-Drowsy

** Allergy Relief

** LORATADINE TABLETS

** USP 10 mg
*
** Antihistamine**
** 24**
****HOUR


**** Relief of:****


*Sneezing *Runny nose *Itchy, watery eyes *Itchy throat or nose

When taken as directed.
**** See Drug Facts Panel.
***


****30 TABLETS Actual Size

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg Blister Carton (30 Tablets)

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/13/2025

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 - PREGNANCY OR BREAST FEEDING SECTION

LOINC: 53414-9Updated: 5/13/2025

If pregnant or breast-feeding,

ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 5/13/2025

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.

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 5/13/2025

Stop use and ask a doctor if

an allergic reaction to this product occurs. Seek medical help right away.

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 5/13/2025

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/13/2025

Active ingredient (in each tablet)

Loratadine USP 10 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/13/2025

Purpose

Antihistamine

WARNINGS SECTION

LOINC: 34071-1Updated: 5/13/2025

Warnings

Do not use


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

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 5/13/2025

Ask a doctor before use if you have

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

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 5/13/2025

When using this product

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/13/2025

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: 5/13/2025

Other information

***Tamper-evident:**do not use if foil seal under cap, printed with “SEALED for YOUR PROTECTION” is missing, open or broken

  • store at 20° to 25°C (68° to 77°F)
  • protect from excessive moisture

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/13/2025

Inactive ingredients

lactose monohydrate, magnesium stearate, pregelatinized starch (maize), sodium starch glycolate.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 5/13/2025

Questions or comments?

call1-855-274-4122


** Distributed by:**CVS Pharmacy, Inc.
****One CVS Drive,
Woonsocket, RI 02895
©2023 CVS/pharmacy
CVS.com®
1-800-SHOP CVS

Made in India V-31735
100 % money back guaranteed.
CVS.com/returnpolicy

Code: TS/DRUGS/22/2009

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Loratadine - FDA Drug Approval Details