Loratadine LORATADINE MYLAN INSTITUTIONAL INC. 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
ANDA076154

Drug Facts

Composition & Profile

Active Ingredients
Active Ingredient (in each tablet) Loratadine USP 10 mg
Inactive Ingredients
Inactive Ingredients Corn starch lactose monohydrate and magnesium stearate.
Strengths
10 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: G;L;10

Identifiers & Packaging

Container Type BOX
UNII
7AJO3BO7QN
Packaging

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. Loratadine Tablets 10 mg Carton Label Outer Carton Label

Package Descriptions
  • 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. Loratadine Tablets 10 mg Carton Label Outer Carton 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 (24 Hour Relief) 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

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.

Questions

Questions or comments? 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


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