LORATADINE LORATADINE BIONPHARMA 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
ANDA202538

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each capsule) Loratadine 10 mg
Inactive Ingredients
Inactive ingredients FD&C blue no.1 gelatin glycerin hypromellose hydrolyzed collagen isopropyl alcohol mannitol medium chain mono- & di-glycerides propylene glycol purified water sorbitan sorbitol titanium dioxide
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: oval Color: blue Imprint: L10

Identifiers & Packaging

Container Type BOX
UNII
7AJO3BO7QN
Packaging

Principal Display Panel 5's Carton

Package Descriptions
  • Principal Display Panel 5's Carton

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 adults and children 6 years and over 1 capsule daily; not more than 1 capsule 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 Tamper-evident: do not use if foil seal under cap, printed with “Sealed for your protection” is missing, open or broken. (For Bottle Labels and Cartons) Safety sealed: do not use if individual blister unit printed with Loratadine Capsule, 10 mg is open or torn. (For Blister Carton) store between 20° to 25°C (68° to 77°F) protect from freezing

Questions

Questions or comments? call toll free 1-888-235-2466 (Mon - Fri 9AM - 5PM EST) † This product is not manufactured or distributed by the owners of Claritin® LIQUI-GELS®. Blister carton contain the following: THIS PRODUCT IS PACKAGED IN A CHILD-RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. Do not use if carton is open, or if individual blister unit is open or torn Manufactured for: Bionpharma Inc. 600 Alexander Road, Princeton, NJ 08540


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