Loratadine Tablet
FDA Label NDC 68210-4110

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Spirit Pharmaceuticals Llc for the product Loratadine (NDC 68210-4110). 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, purpose, uses, do not use, ask a doctor before use if, when usung 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

Loratadine 10 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  •  runny nose
  •  sneezing
  • itchy, water eyes 
  •  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 Usung 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.

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

  • Tamper-evident: do not use if foil under cap is missing, open or broken
  • store between 20° to 25°C (68° to 77°F)

Inactive Ingredients

Lactose monohydrate, magnesium stearate, sodium starch glycolate and starch maize pregelatinized

Questions Or Comments?

1-888-333-9792

Principal Display Panel

Compare to the active ingredient in Claritin®†

NON-DROWSY*

Original Prescription Strength

Loratadine Tablets, 10 mg / Antihistamine

Indoor & Outdoor Allergies

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

365 Tablets

*When taken as directed

See Drug Facts Panel

†This product is not manufactured or distributed by Bayer Healthcare, LLC, owner of the registered trademark Claritin®.

* Please review the disclaimer below.