Loratadine Tablet
FDA Label NDC 68084-248

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by American Health Packaging for the product Loratadine (NDC 68084-248). 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 USP, 10 mg

Purpose

Antihistamine

Uses

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

  • itching of the nose or throat
  • runny nose
  • itchy, watery eyes
  • sneezing

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

  • store between 20° to 25°C (68° to 77°F)
  • protect from excessive moisture
  • FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Inactive Ingredients

Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

Questions?

for Ohm Laboratories call 1-800-406-7984

The drug product contained in this package is from NDC # 51660-526, Ohm Laboratories Inc.

Packaged and Distributed by:
American Health Packaging, Columbus, Ohio 43217

Principal Display Panel – Carton – 10 Mg

NDC 68084-248-01

NON-DROWSY* 24 Hour Allergy Relief
Loratadine
Tablets, USP

10 mg

Antihistamine
Indoor & Outdoor Allergies

100 Tablets (10 x 10)

* When taken as directed. See Drug Facts Panel.

     

The drug product contained in this package is from
NDC # 51660-526, Ohm Laboratories Inc.

Packaged and Distributed by:
American Health Packaging, Columbus, Ohio 43217

801697
0224801/0418

Principal Display Panel – Blister – 10 Mg

Allergy Relief
Loratadine
Tablet, USP           10 mg

* Please review the disclaimer below.