Loratadine

Manufacturer
Safeway, Inc
Effective date
2025-12-19
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:27:31

Key Label Information#

Active Ingredients And Purpose

Active Ingredient (in each tablet)

Loratadine 10mg

Purpose

Antihistamine

Uses

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

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.

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

Directions And Dosage

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

Other Label Information

Other Information

■ safety sealed: do not use if the individual blister unit is open or torn ■ store between 20° to 25°C (68° to 77°F) ■ protect from excessive moisture

Inactive Ingredients

lactose monohydrate, magnesium stearate, sodium starch glycolate and starch maize pregelatinized

Questions or comments?

contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST

PDP

Label Images#

CDER portal
CDER portal

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311372loratadine 10 MG 24HR Oral TabletPSN5
311372loratadine 10 MG Oral TabletSCD5
311372loratadine 10 MG 24 HR Oral TabletSY5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-780-03Loratadine30 in 1 BOTTLETABLET305

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
21130-78021130-780-03

Ingredients#

Complete SPL Sections#

Active Ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Loratadine 10mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

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

Do not use

WARNINGS SECTION

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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 Information

STORAGE AND HANDLING SECTION

■ safety sealed: do not use if the individual blister unit is open or torn ■ store between 20° to 25°C (68° to 77°F) ■ protect from excessive moisture

Inactive Ingredients

INACTIVE INGREDIENT SECTION

lactose monohydrate, magnesium stearate, sodium starch glycolate and starch maize pregelatinized

Questions or comments?

OTC - QUESTIONS SECTION

contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST

PDP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Source Document#

Source XML