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
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each tablet) Loratadine USP 5 mg
Inactive Ingredients
Inactive ingredients aspartame citric acid anhydrous colloidal silicon dioxide D&C red No. 27 aluminum lake FD&C blue No. 2 aluminum lake flavor magnesium stearate mannitol microcrystalline cellulose sodium starch glycolate stearic acid
Strengths
5 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: purple Imprint: 753

Identifiers & Packaging

Container Type BOX
All Product Codes
UNII
7AJO3BO7QN
Packaging

Principal Display Panel – 30 Chewable Tablet Blister Pack Carton NDC 51660-753-31 † Compare to the active ingredient of Children’s Claritin® Chewable ages 2 years and older Children’s Loratadine Chewable Tablets USP, 5 mg Antihistamine Indoor & Outdoor Allergies 30 CHEWABLE TABLETS The chewable tablets are to be chewed before swallowing. Grape Flavored Non-Drowsy* 24 Hour Relief Of: • Sneezing • Runny Nose • Itchy, Watery Eyes • Itchy Nose or Throat * When taken as directed. See Drug Facts Panel. † Ohm® is a registered trademark of Sun Pharmaceutical Industries, Inc. All other trademarks are property of their respective owners. Carton label

Package Descriptions
  • Principal Display Panel – 30 Chewable Tablet Blister Pack Carton NDC 51660-753-31 † Compare to the active ingredient of Children’s Claritin® Chewable ages 2 years and older Children’s Loratadine Chewable Tablets USP, 5 mg Antihistamine Indoor & Outdoor Allergies 30 CHEWABLE TABLETS The chewable tablets are to be chewed before swallowing. Grape Flavored Non-Drowsy* 24 Hour Relief Of: • Sneezing • Runny Nose • Itchy, Watery Eyes • Itchy Nose or Throat * When taken as directed. See Drug Facts Panel. † Ohm® is a registered trademark of Sun Pharmaceutical Industries, Inc. All other trademarks are property of their respective owners. Carton label

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 2 tablets daily; not more than 2 tablets in 24 hours children 2 to under 6 years of age chew 1 tablet daily; not more than 1 tablet 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. Ask a doctorbefore 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. 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

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).

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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