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

NDC Product Code69842-242
Application NumberANDA208314
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMay 13, 2025
Generic NameLoratadine

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

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