Loratadine LORATADINE ORAL BLUEPOINT LABORATORIES 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
Package NDC

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 120 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
All Product Codes
UNII
7AJO3BO7QN
Packaging

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg/5 mL (120 mL Bottle) NDC 68001-449-98 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 4FL OZ (120 mL) Loratadine OS 5mg/5ml Loratadine OS Label; PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg/5 mL Carton (120 mL) NDC 68001-449-98 #Compare to the active ingredient in children’s Claritin® Ages 2years 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 Sugar-Free Alcohol Free Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions. * When taken as directed. See Drug Facts Panel. Grape Flavor 4 FL OZ (120 mL) Loratadine OS 5mg/5ml carton Loratadine OS Carton

Package Descriptions
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg/5 mL (120 mL Bottle) NDC 68001-449-98 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 4FL OZ (120 mL) Loratadine OS 5mg/5ml Loratadine OS Label
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg/5 mL Carton (120 mL) NDC 68001-449-98 #Compare to the active ingredient in children’s Claritin® Ages 2years 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 Sugar-Free Alcohol Free Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions. * When taken as directed. See Drug Facts Panel. Grape Flavor 4 FL OZ (120 mL) Loratadine OS 5mg/5ml carton Loratadine OS 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 use only with enclosed dosing cup mL= milliliter adults and children 6 years and over 10mL daily; do not take more than 10mL in 24 hours children 2 to under 6 years of age 5mL daily; do not take more than 5mL 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 5mLcontains : 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 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 090, India For BluePoint Laboratories Code:TS/DRUGS/19/1993 Revised: 04/2025


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