Loratadine

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Loratadine, USP 10 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

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

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

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE 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

SPL UNCLASSIFIED SECTION

• safety sealed: do not use if the printed bottle seal is open or torn
• store at 20º-25ºC (68º-77ºF) (see USP Controlled Room Temperature)

Inactive ingredients

INACTIVE INGREDIENT SECTION

lactose monohydrate,magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-753-3935 Monday-Friday 9 AM-5 PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

†Compare to the active ingredient in Claritin®

Loratadine tablets, USP

Antihistamine

10 mg

Non-drowsy*

Indoor & outdoor allergies

24-hour relief of

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

100 Tablets

*When taken as directed. See Drug Facts panel

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

†This product is not manufactured or distributed by Bayer HealthCare LLC, distributor of Claritin®

Manufactured by:

Avema Pharm Solutions

10400 NW 29th Terrace, Miami, FL 33172

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

FDA-Initiated Inactive NDC Indexing#

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Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

• Loratadine
• LACTOSE MONOHYDRATE
• MAGNESIUM STEARATE
• MICROCRYSTALLINE CELLULOSE
• SODIUM STARCH GLYCOLATE TYPE A POTATO

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML · Source PDF

Orange Book application contexts#

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Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Observed Orange Book product history#

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Product history page 1 of 2 · 43 observed states.

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