Loratadine LORATADINE TENSHI KAIZEN PVT LTD FDA Approved 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
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Substance Loratadine
Route
ORAL
Applications
ANDA212795
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each tablet) Loratadine 5 mg
Inactive Ingredients
Inactive ingredients anhydrous citric acid mannitol peppermint flavor polysorbate 80 pullulan
Strengths
5 mg
Treats Conditions
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
Pill Appearance
Shape: round Color: white Imprint: T5

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
7AJO3BO7QN
Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL label

Package Descriptions
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL label

Overview

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

Indications & Usage

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

Dosage & Administration

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

Warnings & Precautions
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.
Purpose

Purpose Antihistamine

Do Not Use

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

When Using

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

Stop Use & Ask a Doctor

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

Keep Out of Reach of Children

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

Storage & Handling

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

Questions

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.


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