Loratadine LORATADINE ORAL AUROHEALTH LLC 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
FunFoxMeds bottle
Substance Loratadine
Route
ORAL
Applications
ANDA208931

Drug Facts

Composition & Profile

Active Ingredients
Drug Facts Active ingredient (in each 5 mL) Loratadine USP 5 mg
Inactive Ingredients
Inactive ingredients artificial flavors ascorbic acid glycerin maltitol monobasic sodium phosphate monohydrate phosphoric acid propylene glycol purified water sodium benzoate sodium metabisulfite sorbitol sucralose.
Strengths
5 ml 5 mg
Quantities
5 ml 60 ml
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
Color: yellow

Identifiers & Packaging

Container Type BOTTLE
UNII
7AJO3BO7QN
Packaging

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg/5 mL (60 mL Bottle) AUROHEALTH NDC 58602-423-11 Ages 2 years and older Loratadine Oral Solution USP 5 mg/5 mL Antihistamine Non-Drowsy* 24 Hour Relief of: Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose Do not use if carton is opened, or if cap safety seal is broken or missing. Dye-Free Sugar-Free Alcohol Free Indoor & Outdoor Allergies Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions. * When taken as directed. See Drug Facts Panel. Grape Flavor 2 FL OZ (60 mL) PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg/5 mL (60 mL Bottle); PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg/5 mL Carton (60 mL) AUROHEALTH NDC 58602-423-11 # Compare to the active ingredient in children’s Claritin ® Ages 2 years and older Loratadine Oral Solution USP 5 mg/5 mL Antihistamine Non-Drowsy* 24 Hour Relief of: Sneezing Runny Nose Itchy,watery Eyes Itchy Throat or Nose Indoor & Outdoor Allergies Dosing Cup Included Dye-Free Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions. * When taken as directed. See Drug Facts Panel. Grape Flavor 2 FL OZ (60 mL) PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg/5 mL Carton (60 mL)

Package Descriptions
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg/5 mL (60 mL Bottle) AUROHEALTH NDC 58602-423-11 Ages 2 years and older Loratadine Oral Solution USP 5 mg/5 mL Antihistamine Non-Drowsy* 24 Hour Relief of: Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose Do not use if carton is opened, or if cap safety seal is broken or missing. Dye-Free Sugar-Free Alcohol Free Indoor & Outdoor Allergies Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions. * When taken as directed. See Drug Facts Panel. Grape Flavor 2 FL OZ (60 mL) PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg/5 mL (60 mL Bottle)
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg/5 mL Carton (60 mL) AUROHEALTH NDC 58602-423-11 # Compare to the active ingredient in children’s Claritin ® Ages 2 years and older Loratadine Oral Solution USP 5 mg/5 mL Antihistamine Non-Drowsy* 24 Hour Relief of: Sneezing Runny Nose Itchy,watery Eyes Itchy Throat or Nose Indoor & Outdoor Allergies Dosing Cup Included Dye-Free Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions. * When taken as directed. See Drug Facts Panel. Grape Flavor 2 FL OZ (60 mL) PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg/5 mL Carton (60 mL)

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 use only with enclosed dosing cup mL = milliliter adults and children 6 years and over 10 mL daily; do not take more than 10 mL in 24 hours children 2 to under 6 years of age 5 mL daily; do not take more than 5 mL in 24 hours children under 2 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.
Purpose

Purpose Antihistamine

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 each 5 mL contains : sodium 6 mg do not use if carton is opened, or if cap safety seal is broken or missing. store at 20° to 25°C (68° to 77°F)

Questions

Questions or comments? Call 1-855-274-4122 Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road, East Windsor, NJ 08520 Made in India


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