Loratadine

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

   

SPL UNCLASSIFIED SECTION

Original Prescription Strength Non-Drowsy*

Indoor and Outdoor Allergies

*When taken as directed. See Drug Facts Panel.

TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

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
• itchy, watery eyes
• sneezing
• 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 (24 Hour Relief)

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

• TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
• Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
• protect from excessive moisture

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Corn starch, lactose monohydrate and magnesium stearate.

Questions or comments?

OTC - QUESTIONS SECTION

1-800-848-0462

• Serious side effects associated with use of this product may be reported to this number.

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Made in India

Code No.: MH/DRUGS/25/NKD/89

Distributed by:
Mylan Institutional Inc.
Rockford, IL 61103 U.S.A.

S-11333 R3
1/21

     

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL – 10 mg

NDC 51079-246-20

Loratadine
Tablets, USP
10 mg

Antihistamine

Original Prescription Strength    Non-Drowsy*

Indoor and Outdoor Allergies

24 Hour Relief(See Uses section of enclosed leaflet)

*When taken as directed. See enclosed leaflet.

TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE
TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

DailyMed RxNorm Mappings#

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DailyMed Socrata Ingredients#

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

• Loratadine
• STARCH, CORN
• LACTOSE MONOHYDRATE
• MAGNESIUM STEARATE

NDC Codes#

Ingredients#

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Source Document#

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Inactive ingredient matches#

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Observed Orange Book product history#

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Product history page 1 of 2 · 43 observed states.

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