Loratadine ODT LORATADINE CHAIN DRUG CONSORTIUM, LLC FDA Approved Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat
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Substance Loratadine
Route
ORAL
Applications
ANDA208477
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each tablet) Loratadine USP 10 mg
Inactive Ingredients
Inactive ingredients aspartame crospovidone mannitol microcrystalline cellulose peppermint pregelatinized starch (maize) sodium stearyl fumarate
Strengths
10 mg
Treats Conditions
Uses Temporarily Relieves These Symptoms Due To Hay Fever Or Other Upper Respiratory Allergies Runny Nose Sneezing Itchy Watery Eyes Itching Of The Nose Or Throat
Pill Appearance
Shape: round Color: white Imprint: K;9

Identifiers & Packaging

Container Type BOX
All Product Codes
UPC
0358602744830
UNII
7AJO3BO7QN
Packaging

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg, Blister Carton 10 Orally Disintegrating Tablets NDC 68016-088-10 **Compare to the active ingredient in Claritin ® RediTabs ® Original Prescription Strength Non-Drowsy* Premier Value ® Loratadine Orally Disintegrating Tablets USP 10 mg Allergy Relief Antihistamine Indoor & Outdoor Allergies No Water Needed Melts in Your Mouth 24 Hour Relief of: Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose 10 Orally Disintegrating Tablets *When taken as directed. See Drug Facts Panel. Figure 1

Package Descriptions
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg, Blister Carton 10 Orally Disintegrating Tablets NDC 68016-088-10 **Compare to the active ingredient in Claritin ® RediTabs ® Original Prescription Strength Non-Drowsy* Premier Value ® Loratadine Orally Disintegrating Tablets USP 10 mg Allergy Relief Antihistamine Indoor & Outdoor Allergies No Water Needed Melts in Your Mouth 24 Hour Relief of: Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose 10 Orally Disintegrating Tablets *When taken as directed. See Drug Facts Panel. Figure 1

Overview

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat

Indications & Usage

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes 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 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
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 (1-800-222-1222) right away.

Storage & Handling

Other information Phenylketonurics: Contains phenylalanine 2.25 mg per tablet do not use if the individual blister unit is open or torn store at 20° to 25°C (68° to 77°F) use tablet immediately after opening individual blister Complies with USP test 2 for Disintegration

Questions

Questions or comments? call 1-855-274-4122


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