DYE-FREE LORATADINE LORATADINE OHM LABORATORIES INC. 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
ANDA210088

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each chewable tablet) Loratadine USP 10 mg
Inactive Ingredients
Inactive ingredients aspartame citric acid anhydrous colloidal silicon dioxide flavor magnesium stearate mannitol microcrystalline cellulose sodium starch glycolate stearic acid
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: 10

Identifiers & Packaging

Container Type BOX
UPC
0351660755022
UNII
7AJO3BO7QN
Packaging

PRINCIPAL DISPLAY PANEL - 10 mg Tablet Blister Pack Carton Carton

Package Descriptions
  • PRINCIPAL DISPLAY PANEL - 10 mg Tablet Blister Pack Carton Carton

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 chew or crush tablets completely before swallowing. adults and children 6 years and over chew 1 tablets daily; not more than 1 chewable tablets 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 (1-800-222-1222).
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 (1-800-222-1222).

Storage & Handling

Other information phenylketonurics: contains phenylalanine 1.25 mg per tablet. TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. store between 20° to 25°C (68° to 77°F).

Questions

Questions? call toll-free Monday to Friday 8:30 am to 5:00 pm EST at 1-800-406-7984 . Keep the carton. It contains important information. See end panel for expiration date.


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