Guardian Loratadine
FDA Label NDC 53041-285

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Guardian Drug Company for the product Guardian Loratadine (NDC 53041-285). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, use(s), warnings, do not use, ask a doctor before use if you have, when using this product, stop use and ask doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Tablet)

Loratadine USP, 10mg

Purpose

Antihistamine

Use(S)

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

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 Doctor If

an allergic reaction to this product occurs. Seek medical help right away.

If Pregnant Or Breastfeeding,

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.

Directions


 adults and children 6 years and over1 tablet daily; not more than 1 tablet in 24 hours 
 children under 6 years of age ask a doctor
 consumers with liver or kidney disease  ask a doctor




Other Information

  • Store at 20o to 25oC (68o to 77oF) [See USP Controlled Room Temperature]
  • Protect from excessive moisture


    • SAFETY SEALED: DO NOT USE IF THE IMPRINTED BOTTLE SEAL WITH "SEALED FOR YOUR PROTECTION" IS OPEN OR TORN 

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate

Questions Or Comments?

call 1-609-860-2600 Hours: 8am-4pm, EST.

Principal Display Panel

Guardian
NDC 53041-285-21

Non-Drowsy*

Original Prescription Strength

Loratadine
Tablets, USP 10 mg

Antihistamine

Indoor & Outdoor Allergies

24 Hour Relief of:
Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat Or Nose



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285 (285)


* Please review the disclaimer below.