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FDA LABEL GENERIC: Loratadine MFR: CVS PHARMACY, INC

Loratadine 5 Mg Disintegrating Oral Tablet

Drug Facts

Active ingredient (in each tablet)

Loratadine 5 mg

Purpose

Antihistamine

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.

When using this product do not take more than directed. Taking more than directed may cause drowsiness.

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.

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

Directions

place 1 tablet on tongue; tablet disintegrates, with or without water
adults and children 6 years and over 1 tablet every 12 hours; not more than 2 tablets in 24 hours
children under 6 years of age ask a doctor
consumers with liver or kidney disease ask a doctor

Other information

safety sealed: do not use if the individual blister unit imprinted with Loratadine Orally disintegrating Tablet, USP is open or torn store between 20° to 25°C (68° to 77°F) use tablet immediately after opening individual blister complies with USP Procedure 2 for Assay and Organic Impurities and Test 2 for Disintegration

Inactive ingredients

anhydrous citric acid, mannitol, peppermint flavor, polysorbate 80, pullulan

Questions or comments?

1-877-244-9825 - Our Medical Information center shall operate between 9:00 AM to 5:00 PM EST from Monday through Friday (business hours). Queries received outside business hours shall reach voice mail and shall be attended on next business day.

Manufactured by:

Tenshi Kaizen Private Limited

Bengaluru Rural – 562112, India

Distributed by:

CVS Pharmacy, Inc.

Revised: 09/2020

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL