Loratadine Tablet
FDA Label NDC 0904-6852

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Major Pharmaceuticals for the product Loratadine (NDC 0904-6852). 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, uses, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, 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 10 mg

Purpose

Antihistamine

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

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)

Directions

adults and children 6 years and over

1 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

  • do not use if printed foil under cap is broken or missing
  • store between 20° to 25°C (68° to 77°F)

Inactive Ingredients

lactose monohydrate, magnesium stearate, povidone, pregelatinized starch

Questions Or Comments?

1-800-719-9260

Principal Display Panel

COMPARE TO the active ingredient of CLARITIN®

Non-Drowsy* ● Allergy

Original Prescription Strength

*When taken as directed. See Drug Facts Panel.

Loratadine Tablets, 10 mg/Antihistamine

Indoor & Outdoor Allergies

24 HOUR

Actual Size

24 Hour Relief of:

Sneezing; Runny Nose; Itchy, Watery Eyes; Itchy Throat or Nose

100 Tablets

* Please review the disclaimer below.