Loratadine LORATADINE CAMBER CONSUMER CARE INC FDA Approved USE(S) 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
ANDA210409

Drug Facts

Composition & Profile

Active Ingredients
ACTIVE INGREDIENT(S) (in each 5 mL teaspoonful) Loratadine USP 5mg
Inactive Ingredients
INACTIVE INGREDIENTS ART grape flavor edetate disodium dihydrate glycerin maltitol solution monobasic sodium phosphate non crystallizing sorbitol solution phosphoric acid propylene glycol purified water sodium benzoate and sucralose
Strengths
5 ml 5 mg
Quantities
5 ml 120 ml
Treats Conditions
Use S 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 BOX
UNII
7AJO3BO7QN
Packaging

PRINCIPAL DISPLAY PANEL Loratadine Oral Solution USP, 5 mg/5mL 120 mL Carton Label loratadine-os-carton

Package Descriptions
  • PRINCIPAL DISPLAY PANEL Loratadine Oral Solution USP, 5 mg/5mL 120 mL Carton Label loratadine-os-carton

Overview

USE(S) 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

USE(S) 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 adults and children 6 years and over 2 teaspoonfuls (tsp) daily; do not take more than 2 teaspoonfuls (tsp) in 24 hours children 2 to under 6 years of age 1 teaspoonful (tsp) daily; do not take more than 1 teaspoonful (tsp) in 24 hours children under 2 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 right away.

Storage & Handling

STORAGE


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